Platelet -rich plasma (PRP) is currently used as an alternative treatment method for several common orthopaedic-related sports medicine conditions. According to a new study in the October issue of the Journal of the American Academy of Orthopaedic Surgeons (JAAOS), early outcomes of PRP appear promising; however, larger clinical studies are still needed to determine the benefits of its use.
"Some believe that PRP may catalyze the body's repair mechanisms at areas of injury, improve healing and shorten recovery time," said study co-author Michael Hall, MD, a senior orthopaedic surgery resident at the NYU Hospital for Joint Diseases in New York. "However, there currently is minimal evidence of this clinically and more research must be performed."
A Simple Process and Procedure
- Obtaining and utilizing PRP is a relatively simple process: a patient's own blood is placed into a centrifuge that rotates at high speed.
- This procedure separates the red blood cells from the platelets, which are blood cells that release growth factors that help the body heal itself.
- Next, the physician takes the platelet-rich portion of this blood (PRP) and injects it directly into the patient's injured area and the treatment is complete.
PRP Used Primarily for Chronic Conditions
PRP treatments have been used for the past two decades to improve wound healing and bone grafting procedures by plastic and maxillofacial (mouth, jaw and neck) surgeons. It is only in recent years that orthopaedic surgeons and sports medicine specialists have utilized this technology.
PRP use in sports medicine primarily has been for the treatment of chronic tendon conditions, but also for acute muscle injuries and for the augmentation of tendon repair in the operating room.
The most common applications include:
- tennis elbow (lateral epicondylitis);
- Achilles tendonitis (inflammation and swelling of the Achilles tendon);
- patellar tendonitis (inflammation of the patellar tendon, also called "Jumper's Knee"); and
- rotator cuff tendonopathy.
Should I Have PRP Treatment?
According to Dr. Hall, PRP use has increased in recent years, and it has become a popular topic of discussion because the process is "simple, quick and relatively safe for patients."
"Use of PRP has increased, in large part due to new devices that enable fast preparation in the outpatient setting. A patient gives a blood sample and 30 minutes later can receive their injection," he explained. "There is always a risk of infection with any injection, and some have reported increased pain or inflammation at the injection site, but otherwise the risks with PRP appear minimal."
Questions to Ask Your Doctor
Each patient and injury is unique; therefore it is important to discuss any treatment with an orthopaedic surgeon. If PRP treatment is recommended, Dr. Hall suggests asking your doctor the following to help determine if it is right for you:
1. What is your experience in administering PRP? (Precise placement of PRP injection into the area of injury is important for it to be effective, therefore physicians with more experience may be best.)
2. What are possible side effects? (Examples include increased pain or inflammation at the injection site.)
3. How many injections will I receive? (Several studies have reported using multiple injections, but the benefit of this is unknown.)
4. Will there be any restrictions? (Generally, patients are asked to avoid strenuous activity or sports for a short period of time after the injection to aid in the healing process.)
5. Will my insurance cover treatment? (Currently, most insurance companies do not cover treatment.)
Also, before embarking on PRP, Dr. Hall suggests trying conventional treatments, such as anti-inflammatory medications, physical therapy, massage, activity modification, bracing and even cortisone injections.
"The bottom line is that there are some studies indicating that PRP may be beneficial in the healing process. Does it really have a positive effect clinically? We don't know," said Dr. Hall. "The good news is that there are a tremendous amount of studies underway. Hopefully, in the next few years, we will be able to help determine the true benefit of PRP."
Source
American Academy of Orthopaedic Surgeons (AAOS)
вторник, 28 июня 2011 г.
суббота, 25 июня 2011 г.
Radius Completes Enrollment Of Phase II Clinical Trial Of BA058 For Osteoporosis
Radius Health
("Radius") announced the completion of patient enrollment into its
Phase II clinical trial of BA058, the company's bone anabolic candidate for
treatment of osteoporosis. The Phase II dose-finding study is designed to
further evaluate the ability of BA058 to build new bone for the treatment
of osteoporosis in postmenopausal women. Radius also announced today the
receipt of a second-tranche financing of $28.3 million based on achieving
this milestone, for a total second institutional investment of $67.5
million. Six existing venture investors-MPM Capital, The Wellcome Trust,
HealthCare Ventures, Oxford Bioscience Partners, BB Biotech Ventures, and
Scottish Widows Investment Partnership-participated in the latest closing.
Radius will use the funds to support development of the company's four
major product candidates.
The randomized, double-blind, placebo- and comparator-controlled Phase
II study is evaluating BA058 in 244 otherwise healthy postmenopausal women
with osteoporosis at 35 centers in the United States, United Kingdom,
Argentina, and India. The trial is designed to evaluate the safety of BA058
across a range of doses as well as its ability to induce bone formation
without inducing resorption through measurement of bone formation and
resorption markers and by measuring bone mineral density using a number of
different modalities. Radius expects to report the results of the Phase II
clinical trial by the end of 2008.
"The completion of patient recruitment in this Phase II trial is a very
significant achievement for Radius, and we are grateful for the enthusiasm
of our investigators, who have worked diligently to exceed our enrollment
target for this study," said C. Richard Lyttle, PhD, President and CEO of
Radius. "We believe that BA058 represents a next-generation bone anabolic
treatment for osteoporosis that promises to build bone more rapidly and to
be more convenient for patients to use. We look forward to communicating
the results later this year."
About BA058
PTHrP (parathyroid hormone-related protein) is a critical peptide for
promoting new bone formation, with a role distinct from PTH (parathyroid
hormone), which regulates calcium homeostasis and bone resorption. BA058 is
an analog of hPTHrP that is designed to build bone without inducing
hypercalcemia or significant resorption. In preclinical testing, BA058
demonstrated the potential to widen the anabolic window for bone
therapeutics: i.e., stimulating bone formation with a limited effect on
bone resorption. In Phase I studies, BA058 generally was well tolerated and
did not induce hypercalcemia in doses up to 80 mcg.
About Osteoporosis
Osteoporosis is a leading cause of morbidity and mortality in elderly
people worldwide. In the U.S. alone, more than 44 million men and women
have osteoporosis or low bone-mineral density. A 50-year-old woman in the
U.S. has a 40 percent lifetime risk of osteoporotic fracture. Twenty
percent of hip- fracture patients enter long-term care, and half of this
group never returns to living independently.
About Radius
Radius is a leading company in the discovery and development of a new
generation of drug therapies for osteoporosis and women's health. Radius
has raised $91.5 million in private equity financing since its
establishment in 2003 and is based in Cambridge, Massachusetts.
Radius
radiuspharm
("Radius") announced the completion of patient enrollment into its
Phase II clinical trial of BA058, the company's bone anabolic candidate for
treatment of osteoporosis. The Phase II dose-finding study is designed to
further evaluate the ability of BA058 to build new bone for the treatment
of osteoporosis in postmenopausal women. Radius also announced today the
receipt of a second-tranche financing of $28.3 million based on achieving
this milestone, for a total second institutional investment of $67.5
million. Six existing venture investors-MPM Capital, The Wellcome Trust,
HealthCare Ventures, Oxford Bioscience Partners, BB Biotech Ventures, and
Scottish Widows Investment Partnership-participated in the latest closing.
Radius will use the funds to support development of the company's four
major product candidates.
The randomized, double-blind, placebo- and comparator-controlled Phase
II study is evaluating BA058 in 244 otherwise healthy postmenopausal women
with osteoporosis at 35 centers in the United States, United Kingdom,
Argentina, and India. The trial is designed to evaluate the safety of BA058
across a range of doses as well as its ability to induce bone formation
without inducing resorption through measurement of bone formation and
resorption markers and by measuring bone mineral density using a number of
different modalities. Radius expects to report the results of the Phase II
clinical trial by the end of 2008.
"The completion of patient recruitment in this Phase II trial is a very
significant achievement for Radius, and we are grateful for the enthusiasm
of our investigators, who have worked diligently to exceed our enrollment
target for this study," said C. Richard Lyttle, PhD, President and CEO of
Radius. "We believe that BA058 represents a next-generation bone anabolic
treatment for osteoporosis that promises to build bone more rapidly and to
be more convenient for patients to use. We look forward to communicating
the results later this year."
About BA058
PTHrP (parathyroid hormone-related protein) is a critical peptide for
promoting new bone formation, with a role distinct from PTH (parathyroid
hormone), which regulates calcium homeostasis and bone resorption. BA058 is
an analog of hPTHrP that is designed to build bone without inducing
hypercalcemia or significant resorption. In preclinical testing, BA058
demonstrated the potential to widen the anabolic window for bone
therapeutics: i.e., stimulating bone formation with a limited effect on
bone resorption. In Phase I studies, BA058 generally was well tolerated and
did not induce hypercalcemia in doses up to 80 mcg.
About Osteoporosis
Osteoporosis is a leading cause of morbidity and mortality in elderly
people worldwide. In the U.S. alone, more than 44 million men and women
have osteoporosis or low bone-mineral density. A 50-year-old woman in the
U.S. has a 40 percent lifetime risk of osteoporotic fracture. Twenty
percent of hip- fracture patients enter long-term care, and half of this
group never returns to living independently.
About Radius
Radius is a leading company in the discovery and development of a new
generation of drug therapies for osteoporosis and women's health. Radius
has raised $91.5 million in private equity financing since its
establishment in 2003 and is based in Cambridge, Massachusetts.
Radius
radiuspharm
среда, 22 июня 2011 г.
Link Between Muscle Loss In Elderly And Blood Vessels' Failure To Dilate
Why do people become physically weaker as they age? And is there any way to slow, stop, or even reverse this process, breaking the link between increasing age and frailty?
In a paper published online this Wednesday in the Journal of Clinical Endocrinology & Metabolism, University of Texas Medical Branch at Galveston researchers present evidence that answers to both those questions can be found in the way the network of blood vessels that threads through muscles responds to the hormone insulin.
Normally, these tiny tubes are closed, but when a young person eats a meal and insulin is released into the bloodstream, they open wide to allow nutrients to reach muscle cells. In elderly people, however, insulin has no such "vasodilating" effect.
"We were unsure as to whether decreased vasodilation was just one of the side effects of aging or was one of the main causes of the reduction in muscle protein synthesis in elderly people, because when nutrients and insulin get into muscle fibers, they also turn on lots of intracellular signals linked to muscle growth," said UTMB's Dr. Elena Volpi, senior author of the paper. "This research really demonstrates that vasodilation is a necessary mechanism for insulin to stimulate muscle protein synthesis."
Volpi and her collaborators reached this conclusion after an experiment in which they infused an amount of insulin equivalent to that generated by the body in response to a single meal into the thigh muscles of two sets of young volunteers. One group had been given a drug that blocked vasodilation, while the other was allowed to respond normally. Measurements of muscle protein synthesis levels where made using chemical tracers, while biopsies yielded data on specific biochemical pathways linked to muscle growth.
"We found that by blocking vasodilation, we reproduced in young people the entire response that we see in older persons - a blunting of muscle protein response and a lack of net muscle growth. In other words, from a muscle standpoint, we made young people look 50 years older," Volpi said.
Such results point the way to what could be a powerful new therapy for age-related frailty and the health and quality-of-life problems that come with it.
"Eventually, if we can improve muscle growth in response to feeding in old people by improving blood flow, then we're going to have a major tool to reduce muscle loss with aging, which by itself is associated with reduction in physical functioning and increased risk of disability," Volpi said.
Other authors of the paper ("Insulin Stimulates Human Skeletal Muscle Protein Synthesis via an Indirect Mechanism Involving Endothelial-Dependent Vasodilation and Mammalian Target of Rapamycin Complex 1 Signaling") were lead author and postdoctoral fellow Kyle Timmerman, medical student Jessica Lee, assistant professor Hans Dreyer, research scientist Shaheen Dhanani, graduate students Erin Glynn and Christopher Fry, assistant professor Micah Drummond, associate professor Melinda Sheffield Moore, and professor Blake Rasmussen. Specialized metabolic studies were conducted by the staff of the UTMB Clinical Research Center, part of the university's Institute for Translational Sciences. The National Institute on Aging, the UTMB Claude D. Pepper Center Older Americans Independence Center, the National Institute of Child Health and Human Development and the UTMB Clinical Translational Sciences Award supported this study.
Source:
Jim Kelly
University of Texas Medical Branch at Galveston
In a paper published online this Wednesday in the Journal of Clinical Endocrinology & Metabolism, University of Texas Medical Branch at Galveston researchers present evidence that answers to both those questions can be found in the way the network of blood vessels that threads through muscles responds to the hormone insulin.
Normally, these tiny tubes are closed, but when a young person eats a meal and insulin is released into the bloodstream, they open wide to allow nutrients to reach muscle cells. In elderly people, however, insulin has no such "vasodilating" effect.
"We were unsure as to whether decreased vasodilation was just one of the side effects of aging or was one of the main causes of the reduction in muscle protein synthesis in elderly people, because when nutrients and insulin get into muscle fibers, they also turn on lots of intracellular signals linked to muscle growth," said UTMB's Dr. Elena Volpi, senior author of the paper. "This research really demonstrates that vasodilation is a necessary mechanism for insulin to stimulate muscle protein synthesis."
Volpi and her collaborators reached this conclusion after an experiment in which they infused an amount of insulin equivalent to that generated by the body in response to a single meal into the thigh muscles of two sets of young volunteers. One group had been given a drug that blocked vasodilation, while the other was allowed to respond normally. Measurements of muscle protein synthesis levels where made using chemical tracers, while biopsies yielded data on specific biochemical pathways linked to muscle growth.
"We found that by blocking vasodilation, we reproduced in young people the entire response that we see in older persons - a blunting of muscle protein response and a lack of net muscle growth. In other words, from a muscle standpoint, we made young people look 50 years older," Volpi said.
Such results point the way to what could be a powerful new therapy for age-related frailty and the health and quality-of-life problems that come with it.
"Eventually, if we can improve muscle growth in response to feeding in old people by improving blood flow, then we're going to have a major tool to reduce muscle loss with aging, which by itself is associated with reduction in physical functioning and increased risk of disability," Volpi said.
Other authors of the paper ("Insulin Stimulates Human Skeletal Muscle Protein Synthesis via an Indirect Mechanism Involving Endothelial-Dependent Vasodilation and Mammalian Target of Rapamycin Complex 1 Signaling") were lead author and postdoctoral fellow Kyle Timmerman, medical student Jessica Lee, assistant professor Hans Dreyer, research scientist Shaheen Dhanani, graduate students Erin Glynn and Christopher Fry, assistant professor Micah Drummond, associate professor Melinda Sheffield Moore, and professor Blake Rasmussen. Specialized metabolic studies were conducted by the staff of the UTMB Clinical Research Center, part of the university's Institute for Translational Sciences. The National Institute on Aging, the UTMB Claude D. Pepper Center Older Americans Independence Center, the National Institute of Child Health and Human Development and the UTMB Clinical Translational Sciences Award supported this study.
Source:
Jim Kelly
University of Texas Medical Branch at Galveston
воскресенье, 19 июня 2011 г.
Potential Of BQTTM As A Test For Osteoporosis
Crescent Diagnostics Ltd ("Crescent") has announced the publication of a
recent study demonstrating the potential of the Bone Quality Test, BQTTM to
diagnose osteoporosis. More women at risk can be screened with an accurate,
simple to use test which does not require a hospital visit.
Crescent is conducting multiple clinical studies to investigate the ability
of the BQTTM to detect osteoporosis and expand the screening of women at
risk. The most recent published study carried out at the University of
Limerick, Ireland compared the potential of the BQTTM to identify patients
at risk of fracture with DXA, the current reference standard that measures
bone mineral density ("BMD"). The study compared the fingernail clippings of
169 patients, 39 with a history of fracture and the remainder in a control
group with no fracture history. The lower disulphide content in nails
obtained from patients with a history of fracture was statistically
significantly lower than in patients without a history of fracture
(p=0.025). 26 out of 39 subjects (67%) with a history of fracture recorded
values below the cut-off value for disulphide content of the nail as
measured by Raman spectroscopy.
Commenting on these findings Ernest Poku, Chief Executive Officer of
Crescent said, "We are pleased that these preliminary results confirm the
earlier clinical findings and show the potential of the BQTTM to aid the
identification of individuals at risk of osteoporosis at a much lower cost
than current tests."
Crescent recently began recruiting patients for FRAN, a large multi-centre
trial in the UK and Ireland. This study aims to demonstrate the potential of
the BQTTM to evaluate fracture risk in hundreds of post-menopausal women.
The results are expected in early 2008.
Mr. Poku explained that Crescent "now plans to enter into dialogue with
regulatory agencies to determine the optimum route to market approval for
the test". The company is planning to complete a Series A funding round in
early 2008 to provide the funding to complete the BQTTM regulatory process.
Crescent, founded in 2004, is a development stage diagnostic company focused
on advancing its BQTTM. Low cost accurate alternatives to DEXA are needed to
enable wider osteoporosis screening.
About Crescent Diagnostics Ltd
Crescent Diagnostics is redefining the diagnosis and treatment of
osteoporosis by developing the BQTTM, a novel test which assesses human
fingernail structure as a surrogate marker for bone structure. A BQTTM Point
of Care test could be simple and accurate enough to enable wider population
screening, addressing a market exceeding $700m. Crescent Diagnostics has
offices in Limerick, Ireland and London, UK. For more information visit
crescentds
About Bone Quality Test, BQTTM
The Bone Quality Test is a Raman spectroscopy analysis performed on the nail
in-situ or on a nail clipping. The results are highly repeatable and the
test can be delivered at the point of care cost effectively. The BQTTM
addresses the need for more accurate osteoporosis testing to reduce
fractures in the community which costs billions of dollars worldwide
annually.
Journal Reference
Towler et al - Journal of Materials Science: Materials in Medicine. J Mater
Sci: Mater Med (2007) 18:759-763. Published as epub ahead of print 30
November 2006
recent study demonstrating the potential of the Bone Quality Test, BQTTM to
diagnose osteoporosis. More women at risk can be screened with an accurate,
simple to use test which does not require a hospital visit.
Crescent is conducting multiple clinical studies to investigate the ability
of the BQTTM to detect osteoporosis and expand the screening of women at
risk. The most recent published study carried out at the University of
Limerick, Ireland compared the potential of the BQTTM to identify patients
at risk of fracture with DXA, the current reference standard that measures
bone mineral density ("BMD"). The study compared the fingernail clippings of
169 patients, 39 with a history of fracture and the remainder in a control
group with no fracture history. The lower disulphide content in nails
obtained from patients with a history of fracture was statistically
significantly lower than in patients without a history of fracture
(p=0.025). 26 out of 39 subjects (67%) with a history of fracture recorded
values below the cut-off value for disulphide content of the nail as
measured by Raman spectroscopy.
Commenting on these findings Ernest Poku, Chief Executive Officer of
Crescent said, "We are pleased that these preliminary results confirm the
earlier clinical findings and show the potential of the BQTTM to aid the
identification of individuals at risk of osteoporosis at a much lower cost
than current tests."
Crescent recently began recruiting patients for FRAN, a large multi-centre
trial in the UK and Ireland. This study aims to demonstrate the potential of
the BQTTM to evaluate fracture risk in hundreds of post-menopausal women.
The results are expected in early 2008.
Mr. Poku explained that Crescent "now plans to enter into dialogue with
regulatory agencies to determine the optimum route to market approval for
the test". The company is planning to complete a Series A funding round in
early 2008 to provide the funding to complete the BQTTM regulatory process.
Crescent, founded in 2004, is a development stage diagnostic company focused
on advancing its BQTTM. Low cost accurate alternatives to DEXA are needed to
enable wider osteoporosis screening.
About Crescent Diagnostics Ltd
Crescent Diagnostics is redefining the diagnosis and treatment of
osteoporosis by developing the BQTTM, a novel test which assesses human
fingernail structure as a surrogate marker for bone structure. A BQTTM Point
of Care test could be simple and accurate enough to enable wider population
screening, addressing a market exceeding $700m. Crescent Diagnostics has
offices in Limerick, Ireland and London, UK. For more information visit
crescentds
About Bone Quality Test, BQTTM
The Bone Quality Test is a Raman spectroscopy analysis performed on the nail
in-situ or on a nail clipping. The results are highly repeatable and the
test can be delivered at the point of care cost effectively. The BQTTM
addresses the need for more accurate osteoporosis testing to reduce
fractures in the community which costs billions of dollars worldwide
annually.
Journal Reference
Towler et al - Journal of Materials Science: Materials in Medicine. J Mater
Sci: Mater Med (2007) 18:759-763. Published as epub ahead of print 30
November 2006
четверг, 16 июня 2011 г.
PENNSAID(R) Launch Brings New Treatment To Knee Osteoarthritis Patients
Covidien (NYSE: COV), a leading global provider of healthcare products, has introduced PENNSAID® (diclofenac sodium topical solution) 1.5% w/w to the U.S. market. PENNSAID is the only FDA-approved topical non-steroidal anti-inflammatory drug (NSAID) in a vehicle solution containing dimethyl sulfoxide (DMSO), a known penetrating agent. It is indicated for treatment of the signs and symptoms of osteoarthritis of the knee(s).
PENNSAID offers patients suffering from osteoarthritis of the knee an effective option for reducing pain and improving physical function.
"We believe PENNSAID will become an important treatment for physicians caring for patients with osteoarthritis of the knee," said Timothy R. Wright, President, Pharmaceuticals, Covidien. "The product's unique formulation with DMSO and its proven clinical effectiveness make it a convenient and innovative treatment for patients who are seeking effective pain relief and improved physical function in their daily lives."
A growing number of guidelines and review committees suggest that the use of topical NSAIDs in the treatment of knee osteoarthritis offers potential significant gastrointestinal safety benefits for certain patients. Localized treatment may provide improved safety and tolerability benefits.
In Phase III clinical trials, PENNSAID demonstrated statistically significant differences in all three primary efficacy endpoints: pain and physical function (as measured by the Western Ontario and McMaster Universities LK3.1 OA Index, or WOMAC subscale), and patient overall health assessment (POHA) / patient global assessment (PGA).1,2,3
"Ten million Americans suffer from osteoarthritis of the knee, illustrating the clear need for additional treatment alternatives," said Charles Argoff, M.D., Professor of Neurology at Albany Medical College and Director of the Comprehensive Pain Program of Albany Medical Center. "Though osteoarthritis is not preventable, many people are able to manage it and maintain an active lifestyle with a well designed treatment program, including medications, exercise, and physical therapy when needed."
According to the Arthritis Foundation, moderate exercise provides multiple benefits for people with osteoarthritis - reducing joint pain and stiffness, building strong muscle around the joints and increasing flexibility and endurance for osteoarthritic patients.4 Education around appropriate knee osteoarthritis treatment is especially timely, as May is National Arthritis Awareness Month.
Knee osteoarthritis is one of five leading causes of disability among adults5,6 and is a chronic condition characterized by the breakdown of the joint's cartilage. Cartilage cushions the ends of the bones and allows easy movement of joints. The breakdown of this cartilage causes the bones to rub against each other, resulting in stiffness, pain and loss of movement in the joint.7
Symptoms of osteoarthritis include joint pain or stiffness following periods of either inactivity or excessive use, a grating or catching sensation during joint movement and bone spurs (small growth of new bone) in the affected joints.7
Last November, Covidien with Nuvo Research announced the U.S. Food and Drug Administration (FDA) had approved the New Drug Application for PENNSAID.
About PENNSAID®
PENNSAID (diclofenac sodium topical solution) 1.5% w/w is a NSAID in a vehicle solution containing the penetrating agent DMSO.1,2 PENNSAID was developed to help increase the effective, local delivery of pain relief to patients suffering from knee osteoarthritis, a disorder impacting an estimated 10 million patients in the United States.8 PENNSAID is the only FDA-approved topical NSAID for the treatment of knee osteoarthritis which demonstrated statistically significant differences in all three primary efficacy endpoints: pain and physical function (WOMAC), patient overall health assessment (POHA) and patient global assessment of knee osteoarthritis.1,2,3,9
About Osteoarthritis
Osteoarthritis is a chronic condition characterized by the breakdown of cartilage in the joint. Cartilage cushions the ends of the bones in joints - such as knees, hands, elbows, wrists, ankles and feet - which allows for easy movement. When this cartilage erodes, bones can rub together, resulting in pain and loss of free movement in the joint. Today, an estimated 27 million Americans live with osteoarthritis.7
The most common symptoms include pain, joint soreness, stiffness and deterioration of overall coordination, posture and walking. Despite the high prevalence of osteoarthritis, there is no cure for this disease, which tends to progressively reduce mobility and the overall health state in affected patients.
Important Risk Information About Pennsaid®
Cardiovascular Risk
- Nonsteroidal anti-inflammatory drugs (NSAIDs) may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk.
- PENNSAID is contraindicated in the perioperative setting of coronary artery bypass graft (CABG) surgery.
Gastrointestinal Risk
- NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events.
PENNSAID is contraindicated in patients:
- with a known hypersensitivity to diclofenac sodium or any other component of PENNSAID
- who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal anaphylactic-like reactions to NSAIDs have been reported in such patients.
Elevation of one or more liver tests may occur during therapy with NSAIDs. PENNSAID should be discontinued immediately if abnormal liver tests persist or worsen.
Use with caution in patients with fluid retention or heart failure. Hypertension can occur with NSAID treatment. Monitor blood pressure closely with PENNSAID treatment.
Long-term administration of NSAIDs can result in renal papillary necrosis and other renal injury. Use PENNSAID with caution in patients at greatest risk of this reaction, including the elderly, those with impaired renal function, heart failure, liver dysfunction, and those taking diuretics and ACE-inhibitors.
Should not be used in pregnant or lactating women and is not approved for use in pediatric patients.
Anaphylactoid reactions may occur in patients without prior exposure to PENNSAID. NSAIDs can cause serious skin adverse events such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal.
The most common treatment-related adverse events in patients receiving PENNSAID were application site skin reactions including dry skin (32%), contact dermatitis characterized by skin erythema and induration (9%), contact dermatitis with vesicles (2%) and pruritus (4%). In a long term safety study, contact dermatitis occurred in 13% and contact dermatitis with vesicles in 10% of patients, generally within the first 6 months of exposure, leading to a withdrawal rate for an application site event of 14%. Other common adverse events greater than placebo include: dyspepsia (9%), abdominal pain (6%), flatulence (4%), diarrhea (4%) and nausea (4%).
Do not apply to open wounds. Protect treated knee(s) from natural or artificial sunlight. Topicals such as sunscreen and bug repellant may be applied after PENNSAID treated knee(s) are completely dry. Avoid contact of PENNSAID with eyes and mucous membranes. Wash and dry hands after use.
Concurrent use with oral NSAIDs should be avoided unless benefit outweighs risk and periodic laboratory evaluations are conducted.
PENNSAID is a registered trademark of Nuvo Research Inc.
1 Simon LS, Grierson LM, Naseer Z, Bookman AAM, Shainhouse JZ. Efficacy and safety of topical diclofenac containing dimethyl sulfoxide (DMSO) compared with those of topical placebo, DMSO vehicle and oral diclofenac for knee osteoarthritis. Pain. 2009; 143:238-245.
2 Roth SH, Shainhouse JZ. Efficacy and safety of a topical diclofenac solution (PENNSAID) in the treatment of primary osteoarthritis of the knee. Arch Intern Med. 2004; 164:2017-2023.
3 PENNSAID Product Insert. Dosage and administration.
4 Arthritis Foundation. Osteoarthritis: Treatment Options "Self-Management Techniques, Exercise" see here [ Last Accessed April 2010]
5 Osteoarthritis. Centers for Disease Control and Prevention Web site. See here. Updated February 4, 2010. [ Last Accessed April 2010]
6 Guccione AA, Felson DT, Anderson JJ, et al. The effects of specific medical conditions on the functional limitations of elders in the Framingham study. Am J Public Health. 1994; 84:351-358. [Last Accessed April 2010]
7 Arthritis Foundation. Osteoarthritis Fact Sheet. See here [ Last Accessed April 2010]
8 Parmet, S., Lynm, C., & Glass, R. M. (2003). Osteoarthritis of the Knee. JAMA, 289(8), 1068.
9 Tugwell, P. S., Wells, G. A., & Shainhouse, J. Z. Equivalence study of a topical diclofenac solution (PENNSAID) compared with oral diclofenac in symptomatic treatment of osteoarthritis of the knee: a randomized controlled trial. Journal of Rheumatology, 2004;31(10), 2002-12.
Source
Covidien
View drug information on Pennsaid.
PENNSAID offers patients suffering from osteoarthritis of the knee an effective option for reducing pain and improving physical function.
"We believe PENNSAID will become an important treatment for physicians caring for patients with osteoarthritis of the knee," said Timothy R. Wright, President, Pharmaceuticals, Covidien. "The product's unique formulation with DMSO and its proven clinical effectiveness make it a convenient and innovative treatment for patients who are seeking effective pain relief and improved physical function in their daily lives."
A growing number of guidelines and review committees suggest that the use of topical NSAIDs in the treatment of knee osteoarthritis offers potential significant gastrointestinal safety benefits for certain patients. Localized treatment may provide improved safety and tolerability benefits.
In Phase III clinical trials, PENNSAID demonstrated statistically significant differences in all three primary efficacy endpoints: pain and physical function (as measured by the Western Ontario and McMaster Universities LK3.1 OA Index, or WOMAC subscale), and patient overall health assessment (POHA) / patient global assessment (PGA).1,2,3
"Ten million Americans suffer from osteoarthritis of the knee, illustrating the clear need for additional treatment alternatives," said Charles Argoff, M.D., Professor of Neurology at Albany Medical College and Director of the Comprehensive Pain Program of Albany Medical Center. "Though osteoarthritis is not preventable, many people are able to manage it and maintain an active lifestyle with a well designed treatment program, including medications, exercise, and physical therapy when needed."
According to the Arthritis Foundation, moderate exercise provides multiple benefits for people with osteoarthritis - reducing joint pain and stiffness, building strong muscle around the joints and increasing flexibility and endurance for osteoarthritic patients.4 Education around appropriate knee osteoarthritis treatment is especially timely, as May is National Arthritis Awareness Month.
Knee osteoarthritis is one of five leading causes of disability among adults5,6 and is a chronic condition characterized by the breakdown of the joint's cartilage. Cartilage cushions the ends of the bones and allows easy movement of joints. The breakdown of this cartilage causes the bones to rub against each other, resulting in stiffness, pain and loss of movement in the joint.7
Symptoms of osteoarthritis include joint pain or stiffness following periods of either inactivity or excessive use, a grating or catching sensation during joint movement and bone spurs (small growth of new bone) in the affected joints.7
Last November, Covidien with Nuvo Research announced the U.S. Food and Drug Administration (FDA) had approved the New Drug Application for PENNSAID.
About PENNSAID®
PENNSAID (diclofenac sodium topical solution) 1.5% w/w is a NSAID in a vehicle solution containing the penetrating agent DMSO.1,2 PENNSAID was developed to help increase the effective, local delivery of pain relief to patients suffering from knee osteoarthritis, a disorder impacting an estimated 10 million patients in the United States.8 PENNSAID is the only FDA-approved topical NSAID for the treatment of knee osteoarthritis which demonstrated statistically significant differences in all three primary efficacy endpoints: pain and physical function (WOMAC), patient overall health assessment (POHA) and patient global assessment of knee osteoarthritis.1,2,3,9
About Osteoarthritis
Osteoarthritis is a chronic condition characterized by the breakdown of cartilage in the joint. Cartilage cushions the ends of the bones in joints - such as knees, hands, elbows, wrists, ankles and feet - which allows for easy movement. When this cartilage erodes, bones can rub together, resulting in pain and loss of free movement in the joint. Today, an estimated 27 million Americans live with osteoarthritis.7
The most common symptoms include pain, joint soreness, stiffness and deterioration of overall coordination, posture and walking. Despite the high prevalence of osteoarthritis, there is no cure for this disease, which tends to progressively reduce mobility and the overall health state in affected patients.
Important Risk Information About Pennsaid®
Cardiovascular Risk
- Nonsteroidal anti-inflammatory drugs (NSAIDs) may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk.
- PENNSAID is contraindicated in the perioperative setting of coronary artery bypass graft (CABG) surgery.
Gastrointestinal Risk
- NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events.
PENNSAID is contraindicated in patients:
- with a known hypersensitivity to diclofenac sodium or any other component of PENNSAID
- who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal anaphylactic-like reactions to NSAIDs have been reported in such patients.
Elevation of one or more liver tests may occur during therapy with NSAIDs. PENNSAID should be discontinued immediately if abnormal liver tests persist or worsen.
Use with caution in patients with fluid retention or heart failure. Hypertension can occur with NSAID treatment. Monitor blood pressure closely with PENNSAID treatment.
Long-term administration of NSAIDs can result in renal papillary necrosis and other renal injury. Use PENNSAID with caution in patients at greatest risk of this reaction, including the elderly, those with impaired renal function, heart failure, liver dysfunction, and those taking diuretics and ACE-inhibitors.
Should not be used in pregnant or lactating women and is not approved for use in pediatric patients.
Anaphylactoid reactions may occur in patients without prior exposure to PENNSAID. NSAIDs can cause serious skin adverse events such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal.
The most common treatment-related adverse events in patients receiving PENNSAID were application site skin reactions including dry skin (32%), contact dermatitis characterized by skin erythema and induration (9%), contact dermatitis with vesicles (2%) and pruritus (4%). In a long term safety study, contact dermatitis occurred in 13% and contact dermatitis with vesicles in 10% of patients, generally within the first 6 months of exposure, leading to a withdrawal rate for an application site event of 14%. Other common adverse events greater than placebo include: dyspepsia (9%), abdominal pain (6%), flatulence (4%), diarrhea (4%) and nausea (4%).
Do not apply to open wounds. Protect treated knee(s) from natural or artificial sunlight. Topicals such as sunscreen and bug repellant may be applied after PENNSAID treated knee(s) are completely dry. Avoid contact of PENNSAID with eyes and mucous membranes. Wash and dry hands after use.
Concurrent use with oral NSAIDs should be avoided unless benefit outweighs risk and periodic laboratory evaluations are conducted.
PENNSAID is a registered trademark of Nuvo Research Inc.
1 Simon LS, Grierson LM, Naseer Z, Bookman AAM, Shainhouse JZ. Efficacy and safety of topical diclofenac containing dimethyl sulfoxide (DMSO) compared with those of topical placebo, DMSO vehicle and oral diclofenac for knee osteoarthritis. Pain. 2009; 143:238-245.
2 Roth SH, Shainhouse JZ. Efficacy and safety of a topical diclofenac solution (PENNSAID) in the treatment of primary osteoarthritis of the knee. Arch Intern Med. 2004; 164:2017-2023.
3 PENNSAID Product Insert. Dosage and administration.
4 Arthritis Foundation. Osteoarthritis: Treatment Options "Self-Management Techniques, Exercise" see here [ Last Accessed April 2010]
5 Osteoarthritis. Centers for Disease Control and Prevention Web site. See here. Updated February 4, 2010. [ Last Accessed April 2010]
6 Guccione AA, Felson DT, Anderson JJ, et al. The effects of specific medical conditions on the functional limitations of elders in the Framingham study. Am J Public Health. 1994; 84:351-358. [Last Accessed April 2010]
7 Arthritis Foundation. Osteoarthritis Fact Sheet. See here [ Last Accessed April 2010]
8 Parmet, S., Lynm, C., & Glass, R. M. (2003). Osteoarthritis of the Knee. JAMA, 289(8), 1068.
9 Tugwell, P. S., Wells, G. A., & Shainhouse, J. Z. Equivalence study of a topical diclofenac solution (PENNSAID) compared with oral diclofenac in symptomatic treatment of osteoarthritis of the knee: a randomized controlled trial. Journal of Rheumatology, 2004;31(10), 2002-12.
Source
Covidien
View drug information on Pennsaid.
понедельник, 13 июня 2011 г.
Fall Chores Spark Safety Advice From Orthopaedic Surgeons
It's that time of year again and the fall season has begun. As each changing season brings its own set of activities and chores, families start thinking about outdoor yardwork. From raking leaves, to mowing lawns and using ladders, the American Academy of Orthopaedic Surgeons (AAOS) offers outdoor safety advice to make sure your autumn clean-up is as safe and injury-free as possible.
According to the Consumer Product Safety Commission, in 2008, about 617,000 people were injured due to rakes, other outdoor garden supplies and ladders alone.
"Many people work vigorously in the yard during the autumn season and it often takes a toll on your body," stated Laurence Laudicina, MD, an orthopaedic surgeon who specializes in sports medicine and spokesperson for the AAOS. "Raking leaves and cleaning out the gutters are popular seasonal chores and can lead to falls or strain to your back and upper body," he added.
Rakes and Pains
Orthopaedic surgeons and the AAOS recommend:
-- Warming up for at least 10 minutes with some stretching and light exercise.
-- Using a rake that is comfortable for your height and strength. Wearing gloves or using a rake with padded handles can prevent blisters.
-- Keeping your vision free of impediment, such as hats or scarves and being aware of large rocks, low branches, tree stumps or uneven surfaces.
-- Varying your movement, alternating your leg and arm positions often, and when picking up leaves, bend at the knees, not the waist.
-- Wearing shoes or boots with slip-resistant soles because wet leaves can be slippery.
-- Not overfilling leaf bags, especially if the leaves are wet. To avoid back injury, you should be able to carry bags comfortably.
-- Never throwing leaves over your shoulder or to the side. The twisting motion required to do so places undue stress on your back.
Ladders
Homeowners often take time to clean the leaves out of gutters, check roof integrity and wash windows before the winter begins. However, injuries from ladder use are very common. According to the Consumer Product Safety Commission, in 2008, about 539,000 people went to the doctor, emergency room or hospital due to a ladder injury.
To stay safe on a ladder and avoid injuries:
-- Inspect the ladder for loose screws, hinges or rungs. Clean off any mud, dirt or liquids.
-- Make sure all four legs rest on a firm, level surface. Avoid uneven ground or soft, muddy spots.
-- Always face a ladder when climbing and descending.
-- Be sure that any ladder is fully open and locked, before climbing.
-- Ladders should be angled about 75 degrees from the ground.
-- Wear shoes with nonslip soles on ladders with rounded rungs.
-- Never sit or stand on the top of the ladder or on its pail shelf. It is not designed to carry your weight.
-- Choose the right ladder for the job. A step stool or utility ladder is good for working at low or medium heights, for jobs such as washing windows. Extension ladders are appropriate for outdoors to reach high places, for when you need to clean gutters or inspect the roof.
Source: American Academy of Orthopaedic Surgeons (AAOS)
According to the Consumer Product Safety Commission, in 2008, about 617,000 people were injured due to rakes, other outdoor garden supplies and ladders alone.
"Many people work vigorously in the yard during the autumn season and it often takes a toll on your body," stated Laurence Laudicina, MD, an orthopaedic surgeon who specializes in sports medicine and spokesperson for the AAOS. "Raking leaves and cleaning out the gutters are popular seasonal chores and can lead to falls or strain to your back and upper body," he added.
Rakes and Pains
Orthopaedic surgeons and the AAOS recommend:
-- Warming up for at least 10 minutes with some stretching and light exercise.
-- Using a rake that is comfortable for your height and strength. Wearing gloves or using a rake with padded handles can prevent blisters.
-- Keeping your vision free of impediment, such as hats or scarves and being aware of large rocks, low branches, tree stumps or uneven surfaces.
-- Varying your movement, alternating your leg and arm positions often, and when picking up leaves, bend at the knees, not the waist.
-- Wearing shoes or boots with slip-resistant soles because wet leaves can be slippery.
-- Not overfilling leaf bags, especially if the leaves are wet. To avoid back injury, you should be able to carry bags comfortably.
-- Never throwing leaves over your shoulder or to the side. The twisting motion required to do so places undue stress on your back.
Ladders
Homeowners often take time to clean the leaves out of gutters, check roof integrity and wash windows before the winter begins. However, injuries from ladder use are very common. According to the Consumer Product Safety Commission, in 2008, about 539,000 people went to the doctor, emergency room or hospital due to a ladder injury.
To stay safe on a ladder and avoid injuries:
-- Inspect the ladder for loose screws, hinges or rungs. Clean off any mud, dirt or liquids.
-- Make sure all four legs rest on a firm, level surface. Avoid uneven ground or soft, muddy spots.
-- Always face a ladder when climbing and descending.
-- Be sure that any ladder is fully open and locked, before climbing.
-- Ladders should be angled about 75 degrees from the ground.
-- Wear shoes with nonslip soles on ladders with rounded rungs.
-- Never sit or stand on the top of the ladder or on its pail shelf. It is not designed to carry your weight.
-- Choose the right ladder for the job. A step stool or utility ladder is good for working at low or medium heights, for jobs such as washing windows. Extension ladders are appropriate for outdoors to reach high places, for when you need to clean gutters or inspect the roof.
Source: American Academy of Orthopaedic Surgeons (AAOS)
воскресенье, 12 июня 2011 г.
Surgeon Develops International Database For Scoliosis Treatment
The adolescent and teen years can be tough enough without the disfiguring and activity-limiting effects of scoliosis. 18-year-old William Burnley knows this well. His diagnosis of scoliosis came after he couldn't properly execute directions from his Tae Kwon Do instructor.
"Stand up straight, is what his instructor told him," says Leonard Burnley, William's father. "He replied that he was standing straight! After class, the instructor said that we should take him to a chiropractor."
But William would need more than a chiropractor. When the Burnleys made their way to the University of Virginia's Spine Center, they met with spine orthopaedic surgeon Dr. Vincent Arlet. They learned that William would need surgery to correct the curvature of his spine. Arlet answered their questions with help from a database he invented called Scolisoft.
"There is a lack of evidence-based information about treatment and outcomes for scoliosis," says Arlet. "What little data there is comes mainly in the form of figures and charts."
So Arlet changed that by creating Scolisoft to show clinical pictures and x-rays of different types of spine curvatures. Scolisoft is the largest international, online, spinal deformity database and the only database that carries clinical photographs of surgical patients taken before and after surgery. It also shares information on how each case was treated and the results experienced by each patient. Doctors from around the world can enter similar information about the cases they treat. All together, the information serves as a guide that helps surgeons make decisions about the type of care their individual patients need.
"When you get a new case that you can match with five identical cases in the database, you can see clearly what the best course of treatment was for that particular type of curvature," Arlet says. "The extent of surgery that is needed varies. With information from the database, we can avoid giving too little surgical correction or too much surgical correction and we can determine exactly what is best for the patient."
Scolisoft also lets patients see the type of spine curvature they have and the kinds of results they can expect after surgery. William got to see a photo of the type of curvature that matched his and was excited to see that how straight his back would become.
"I was really impressed by the pictures," William says.
Scolisoft also has implications for medical education. Currently, medical students and residents learn by reviewing medical records, which is time consuming. With Scolisoft, they have a library of cases that they can review and learn from, with just a click of the mouse. Residents with access to the database also learn to set up research protocols. They can study patient satisfaction and body image information items for which Arlet's team will soon have data. Scolisoft is the only database of its kind in the world. Surgeons who use it give overwhelmingly positive feedback.
"Our next step is to increase the number of physicians who use the database and make Scolisoft the reference of choice for teaching, research, and patient education," Arlet adds. Arlet and Mark Abel, pediatric orthopedic surgeon at University of Virginia have constantly been contributing their surgical cases to Scolisoft ever since it has been established at UVA.
Each year, scoliosis affects several thousand people mostly teens. It is a complex deformity of the spine that can be either congenital or idiopathic. If left untreated, scoliosis can worsen or result in respiratory compromise.
Source: University of Virginia Health System
"Stand up straight, is what his instructor told him," says Leonard Burnley, William's father. "He replied that he was standing straight! After class, the instructor said that we should take him to a chiropractor."
But William would need more than a chiropractor. When the Burnleys made their way to the University of Virginia's Spine Center, they met with spine orthopaedic surgeon Dr. Vincent Arlet. They learned that William would need surgery to correct the curvature of his spine. Arlet answered their questions with help from a database he invented called Scolisoft.
"There is a lack of evidence-based information about treatment and outcomes for scoliosis," says Arlet. "What little data there is comes mainly in the form of figures and charts."
So Arlet changed that by creating Scolisoft to show clinical pictures and x-rays of different types of spine curvatures. Scolisoft is the largest international, online, spinal deformity database and the only database that carries clinical photographs of surgical patients taken before and after surgery. It also shares information on how each case was treated and the results experienced by each patient. Doctors from around the world can enter similar information about the cases they treat. All together, the information serves as a guide that helps surgeons make decisions about the type of care their individual patients need.
"When you get a new case that you can match with five identical cases in the database, you can see clearly what the best course of treatment was for that particular type of curvature," Arlet says. "The extent of surgery that is needed varies. With information from the database, we can avoid giving too little surgical correction or too much surgical correction and we can determine exactly what is best for the patient."
Scolisoft also lets patients see the type of spine curvature they have and the kinds of results they can expect after surgery. William got to see a photo of the type of curvature that matched his and was excited to see that how straight his back would become.
"I was really impressed by the pictures," William says.
Scolisoft also has implications for medical education. Currently, medical students and residents learn by reviewing medical records, which is time consuming. With Scolisoft, they have a library of cases that they can review and learn from, with just a click of the mouse. Residents with access to the database also learn to set up research protocols. They can study patient satisfaction and body image information items for which Arlet's team will soon have data. Scolisoft is the only database of its kind in the world. Surgeons who use it give overwhelmingly positive feedback.
"Our next step is to increase the number of physicians who use the database and make Scolisoft the reference of choice for teaching, research, and patient education," Arlet adds. Arlet and Mark Abel, pediatric orthopedic surgeon at University of Virginia have constantly been contributing their surgical cases to Scolisoft ever since it has been established at UVA.
Each year, scoliosis affects several thousand people mostly teens. It is a complex deformity of the spine that can be either congenital or idiopathic. If left untreated, scoliosis can worsen or result in respiratory compromise.
Source: University of Virginia Health System
суббота, 11 июня 2011 г.
Cytokinetics Announces The Initiation Of A First-Time-in-Humans, Phase I Clinical Trial Of CK-2017357
Cytokinetics, Incorporated (NASDAQ: CYTK) announced that the company has initiated a first-time-in-humans, Phase I clinical trial of CK-2017357 in healthy male volunteers. CK-2017357 is a fast skeletal muscle troponin activator and is the lead drug candidate that has emerged from the company's skeletal sarcomere activator program. CK-2017357 selectively activates the troponin complex and increases its sensitivity to calcium, subsequently leading to an increase in skeletal muscle force. This mechanism of action has demonstrated encouraging pharmacological activity in preclinical models that may relate to the potential treatment of diseases associated with aging, muscle wasting, and neuromuscular dysfunction.
This Phase I clinical trial is a double-blind, randomized, placebo-controlled, single ascending dose study designed to evaluate CK-2017357 in healthy male volunteers. Each volunteer will participate in two dosing sessions separated by an adequate washout period. Subjects will be randomized (3:1) at the start of each dosing period to receive active study drug or placebo. The primary objective of this clinical trial is to determine the safety, tolerability and maximum tolerated dose (MTD) of CK-2017357 administered orally. The secondary objective is to evaluate the pharmacokinetic profile of CK-2017357. Following determination of the MTD and the pharmacokinetic profile of CK-2017357, further evaluation of the drug candidate's pharmacodynamic effects on skeletal muscle function in healthy volunteers may be undertaken in a second stage of this clinical trial.
"This first-time-in-humans clinical trial of CK-2017357 builds on our expertise in the biology of muscle function, initially demonstrated with our cardiac muscle myosin activator program and now translated to our skeletal sarcomere activator program," stated Fady Malik, MD, PhD, Cytokinetics' Vice President, Biology and Therapeutics. "This novel drug candidate may represent an important approach to treating skeletal muscle weakness that is a consequence of a wide array of diseases associated with muscle wasting or primary neuromuscular dysfunction."
"The initiation of this Phase I clinical trial is further demonstration of Cytokinetics' expertise in building a portfolio of novel drug candidates that leverage our expertise in the cytoskeletal pharmacology and biology of muscle contractility," stated Robert I. Blum, Cytokinetics' President and CEO. "This drug candidate, along with others we are developing, illustrates the productivity of our research and development teams that have now generated five next-generation drug candidates, which may address significant unmet needs across multiple therapeutic indications."
Background on Skeletal Muscle Activators
Skeletal muscle contractility is driven by the sarcomere, the fundamental unit of skeletal muscle contraction. It is a highly ordered cytoskeletal structure composed of several key proteins. The first, skeletal muscle myosin, is the cytoskeletal motor protein that converts chemical energy into mechanical force through its interaction with a second protein, actin. A set of regulatory proteins, which includes tropomyosin and several types of troponin, make the actin-myosin interaction dependent on changes in intracellular calcium levels. Cytokinetics' skeletal muscle contractility program is focused to the discovery and development of small molecule skeletal sarcomere activators and leverages Cytokinetics' expertise gained from its ongoing discovery and development of cardiac sarcomere activators, including the cardiac myosin activator, CK-1827452, now in Phase II clinical development as a potential treatment for heart failure. In non-clinical models, skeletal sarcomere activators have demonstrated pharmacological activity that may lead to new therapeutic options for diseases associated with aging, muscle wasting, and neuromuscular dysfunction. The clinical effects of muscle wasting, fatigue and loss of mobility can range from decreased quality of life to, in some instances, life-threatening complications. By directly improving skeletal muscle function, a small molecule activator of the skeletal sarcomere may potentially enhance physical performance and quality of life in patients with conditions marked by muscle weakness, including neuromuscular diseases such as amyotrophic lateral sclerosis (ALS), myasthenia gravis, cachexia, sarcopenia and the general frailty associated with aging.
Market Potential for Skeletal Muscle Activators
The conditions that could benefit from a skeletal muscle activator are grievous and severe. ALS, which afflicts between 20,000 and 30,000 people in the United States and is associated with a 3-year mortality rate of 50%. In addition, few options exist for the treatment of other neuromuscular disorders, such as myasthenia gravis, a chronic disease characterized by a defect in the transmission of nerve impulses to skeletal muscles, which afflicts approximately 60,000 patients in the United States. Patients with disorders and conditions with a higher prevalence could also benefit from enhanced skeletal muscle functional performance, including patients with cachexia, intermittent claudication and sarcopenia. Cachexia, a syndrome characterized by a drastic and unintentional loss of body mass, is estimated to be prevalent in 15%-35% of heart failure patients and in approximately 50% of cancer patients. Intermittent claudication, which usually refers to cramping pains in the legs caused by peripheral arterial disease, is a condition that impacts between 1 million and 3 million people in the United States each year. Sarcopenia, which is an age-related loss of muscle mass, strength, and function, is estimated to impact the lives of over 25-30% of the U.S. population over the age of 65 and can result in additional injuries and medical conditions due to limited mobility.
Source
Cytokinetics
This Phase I clinical trial is a double-blind, randomized, placebo-controlled, single ascending dose study designed to evaluate CK-2017357 in healthy male volunteers. Each volunteer will participate in two dosing sessions separated by an adequate washout period. Subjects will be randomized (3:1) at the start of each dosing period to receive active study drug or placebo. The primary objective of this clinical trial is to determine the safety, tolerability and maximum tolerated dose (MTD) of CK-2017357 administered orally. The secondary objective is to evaluate the pharmacokinetic profile of CK-2017357. Following determination of the MTD and the pharmacokinetic profile of CK-2017357, further evaluation of the drug candidate's pharmacodynamic effects on skeletal muscle function in healthy volunteers may be undertaken in a second stage of this clinical trial.
"This first-time-in-humans clinical trial of CK-2017357 builds on our expertise in the biology of muscle function, initially demonstrated with our cardiac muscle myosin activator program and now translated to our skeletal sarcomere activator program," stated Fady Malik, MD, PhD, Cytokinetics' Vice President, Biology and Therapeutics. "This novel drug candidate may represent an important approach to treating skeletal muscle weakness that is a consequence of a wide array of diseases associated with muscle wasting or primary neuromuscular dysfunction."
"The initiation of this Phase I clinical trial is further demonstration of Cytokinetics' expertise in building a portfolio of novel drug candidates that leverage our expertise in the cytoskeletal pharmacology and biology of muscle contractility," stated Robert I. Blum, Cytokinetics' President and CEO. "This drug candidate, along with others we are developing, illustrates the productivity of our research and development teams that have now generated five next-generation drug candidates, which may address significant unmet needs across multiple therapeutic indications."
Background on Skeletal Muscle Activators
Skeletal muscle contractility is driven by the sarcomere, the fundamental unit of skeletal muscle contraction. It is a highly ordered cytoskeletal structure composed of several key proteins. The first, skeletal muscle myosin, is the cytoskeletal motor protein that converts chemical energy into mechanical force through its interaction with a second protein, actin. A set of regulatory proteins, which includes tropomyosin and several types of troponin, make the actin-myosin interaction dependent on changes in intracellular calcium levels. Cytokinetics' skeletal muscle contractility program is focused to the discovery and development of small molecule skeletal sarcomere activators and leverages Cytokinetics' expertise gained from its ongoing discovery and development of cardiac sarcomere activators, including the cardiac myosin activator, CK-1827452, now in Phase II clinical development as a potential treatment for heart failure. In non-clinical models, skeletal sarcomere activators have demonstrated pharmacological activity that may lead to new therapeutic options for diseases associated with aging, muscle wasting, and neuromuscular dysfunction. The clinical effects of muscle wasting, fatigue and loss of mobility can range from decreased quality of life to, in some instances, life-threatening complications. By directly improving skeletal muscle function, a small molecule activator of the skeletal sarcomere may potentially enhance physical performance and quality of life in patients with conditions marked by muscle weakness, including neuromuscular diseases such as amyotrophic lateral sclerosis (ALS), myasthenia gravis, cachexia, sarcopenia and the general frailty associated with aging.
Market Potential for Skeletal Muscle Activators
The conditions that could benefit from a skeletal muscle activator are grievous and severe. ALS, which afflicts between 20,000 and 30,000 people in the United States and is associated with a 3-year mortality rate of 50%. In addition, few options exist for the treatment of other neuromuscular disorders, such as myasthenia gravis, a chronic disease characterized by a defect in the transmission of nerve impulses to skeletal muscles, which afflicts approximately 60,000 patients in the United States. Patients with disorders and conditions with a higher prevalence could also benefit from enhanced skeletal muscle functional performance, including patients with cachexia, intermittent claudication and sarcopenia. Cachexia, a syndrome characterized by a drastic and unintentional loss of body mass, is estimated to be prevalent in 15%-35% of heart failure patients and in approximately 50% of cancer patients. Intermittent claudication, which usually refers to cramping pains in the legs caused by peripheral arterial disease, is a condition that impacts between 1 million and 3 million people in the United States each year. Sarcopenia, which is an age-related loss of muscle mass, strength, and function, is estimated to impact the lives of over 25-30% of the U.S. population over the age of 65 and can result in additional injuries and medical conditions due to limited mobility.
Source
Cytokinetics
пятница, 10 июня 2011 г.
Estrogen Supplements Not As Effective As Claimed
Dietary supplements claiming to help postmenopausal women with bone health may not be doing what they say, according to new research from Purdue University.
"We found that some plant-derived isoflavones have a modest effect on suppressing bone loss during post-menopause, but more concerning is many dietary supplements that claim to have the power of estrogen do not," said Connie Weaver, distinguished professor of foods and nutrition. "It's buyer beware. Some of the supplements in our study claimed to be substitutes for estrogen, yet they weren't effective at all or weren't as effective as some of the current treatments for osteoporosis."
Women who are menopausal or postmenopausal produce less estrogen, and that leads to bone loss. More than 2 million women in the United States reach menopause each year, according to the National Women's Health Resource Center.
Estrogen hormone replacement therapy was the traditional treatment, but it is no longer recommended for the long term because of links to stroke, embolism and breast cancer. Some individuals have harmful side effects with long-term use of bisphosphonates, the current main class of osteoporosis treatment drugs.
"This is a reminder that it's better to build up a good healthy skeleton than to rely on a drug to fix it later," Weaver said. "Healthy bones can be maintained by a good diet that is rich in calcium and regular exercise that includes strength training."
Weaver, who also is co-director of the Botanicals Research Center for Age Related Diseases, and her team looked at four popular isoflavones: soy cotyledon, soy germ, red clover and kudzu. These plant-derived phytoestrogens are claimed to protect bone health from estrogen loss, which can lead to osteoporosis and even fractures.
The researchers compared the four isoflavones to a traditional bisphosphonate treatment, risedronate and estrogen plus progesterone. These traditional therapies decreased bone loss 22 percent to 24 percent, but only soy isoflavones from the cotyledon and germ significantly decreased bone loss by 9 percent and 5 percent, respectively. The findings are available online and will be published in the October edition of the Journal of Clinical Endocrinology and Metabolism.
The findings also indicate that the soy cotyledon was more effective because of its higher genistein content. Weaver's team is currently evaluating the role of genistein more closely.
"Before, we might have assumed that any isoflavone was equally effective, but we found that for a supplement to work it was because of the genistein content specifically," she said.
This work was funded by the National Institutes of Health and supplements were supplied by the dietary and health companies Cognis, Frutarom and Novagen. Weaver also is on the advisory board of Pharmative and Wyeth Global Nutrition. The Botanicals Research Center for Age Related Diseases is a partnership between Purdue and the University of Alabama-Birmingham.
Source:
Amy Patterson Neubert
Purdue University
"We found that some plant-derived isoflavones have a modest effect on suppressing bone loss during post-menopause, but more concerning is many dietary supplements that claim to have the power of estrogen do not," said Connie Weaver, distinguished professor of foods and nutrition. "It's buyer beware. Some of the supplements in our study claimed to be substitutes for estrogen, yet they weren't effective at all or weren't as effective as some of the current treatments for osteoporosis."
Women who are menopausal or postmenopausal produce less estrogen, and that leads to bone loss. More than 2 million women in the United States reach menopause each year, according to the National Women's Health Resource Center.
Estrogen hormone replacement therapy was the traditional treatment, but it is no longer recommended for the long term because of links to stroke, embolism and breast cancer. Some individuals have harmful side effects with long-term use of bisphosphonates, the current main class of osteoporosis treatment drugs.
"This is a reminder that it's better to build up a good healthy skeleton than to rely on a drug to fix it later," Weaver said. "Healthy bones can be maintained by a good diet that is rich in calcium and regular exercise that includes strength training."
Weaver, who also is co-director of the Botanicals Research Center for Age Related Diseases, and her team looked at four popular isoflavones: soy cotyledon, soy germ, red clover and kudzu. These plant-derived phytoestrogens are claimed to protect bone health from estrogen loss, which can lead to osteoporosis and even fractures.
The researchers compared the four isoflavones to a traditional bisphosphonate treatment, risedronate and estrogen plus progesterone. These traditional therapies decreased bone loss 22 percent to 24 percent, but only soy isoflavones from the cotyledon and germ significantly decreased bone loss by 9 percent and 5 percent, respectively. The findings are available online and will be published in the October edition of the Journal of Clinical Endocrinology and Metabolism.
The findings also indicate that the soy cotyledon was more effective because of its higher genistein content. Weaver's team is currently evaluating the role of genistein more closely.
"Before, we might have assumed that any isoflavone was equally effective, but we found that for a supplement to work it was because of the genistein content specifically," she said.
This work was funded by the National Institutes of Health and supplements were supplied by the dietary and health companies Cognis, Frutarom and Novagen. Weaver also is on the advisory board of Pharmative and Wyeth Global Nutrition. The Botanicals Research Center for Age Related Diseases is a partnership between Purdue and the University of Alabama-Birmingham.
Source:
Amy Patterson Neubert
Purdue University
New Evidence Shows MabThera Inhibits Joint Damage In Patients With Rheumatoid Arthritis
New data presented at the EULAR meeting (European League Against Rheumatism) show for the first time that MabThera (rituximab), a unique B cell targeted therapy, is able to significantly inhibit structural damage of joints caused by rheumatoid arthritis (RA). The study was conducted in patients who had an inadequate response to one or more TNF inhibitors and they received either MabThera plus methotrexate (MTX) or MTX alone. X-ray evidence at 56 weeks showed that the progression of bone erosions and progression of narrowing of joint spaces in patients in the MabThera group were reduced by more than 50 % compared to patients receiving MTX alone (erosion scores of 0.59 and 1.32 respectively; joint space narrowing scores of 0.41 and 0.99 respectively).
Damage to the structure of the joints ultimately causes destruction of the joints and contributes to joint deformity and loss of mobility. Patients' ability to work and perform every day tasks such as getting dressed, walking and eating can be severely hampered.
Presenting the results, Professor Keystone, Rheumatology Department at the University of Toronto, Canada, said: "This is the first evidence demonstrating that MabThera can inhibit structural joint damage in patients with an inadequate response to one or more TNF inhibitors. Preventing structural damage is a critical outcome in treating rheumatoid arthritis. These X-ray data confirm MabThera as an effective and innovative therapy for patients with rheumatoid arthritis and highlight the value of targeting B cells."
Repeat treatment courses
Additional new data presented at EULAR demonstrate that repeat courses of MabThera in RA patients, 6 to 12 months after the initial course, provide continued improvement of symptoms across all clinical measures. Each treatment course consists of two infusions of 1000mg given two weeks apart. The challenging goal of treatment in RA is remission and, following a second course of MabThera in patients with an inadequate response to one or more TNF inhibitors, the number of patients achieving remission doubled from 6 % following an initial course to 13 % following a second course. A similar trend was seen for those achieving the hard-to-reach goal of a 70 % improvement in symptoms (ACR70), with responses increasing from 12 % following an initial course to 21 % following a second course.
Patient perspectives
Importantly, data presented at EULAR show improvements in clinical scores are reflected in patient reported outcomes.
"While it is important to a physician to address a disease from a clinical perspective, what matters most to the patient is whether they are able to function normally and how well they feel. For example, the impact of fatigue is often underestimated, but this is something which really impacts patients' lives. MabThera has demonstrated continuous improvements in physical and mental health aspects with repeated courses of therapy", said Professor Tak, Director, Division of Clinical Immunology and Rheumatology at the Academic Medical Centre/University of Amsterdam, The Netherlands.
Approval Status
On 2 June 2006 MabThera received a recommendation for approval from the Committee for Medicinal Products for Human Use (CHMP) for the treatment of rheumatoid arthritis (RA) in Europe. MabThera, in combination with methotrexate, has been recommended for the treatment of adult patients with severe active rheumatoid arthritis who have had an inadequate response or intolerance to other disease-modifying anti-rheumatic drugs (DMARDs). On 28 February 2006, after priority review, Genentech and Biogen Idec received US approval for Rituxan (rituximab in the US) for the treatment of adult patients with moderately to severely active RA in combination with methotrexate for reducing signs and symptoms in those RA patients who have had an inadequate response to one or more tumour necrosis factor (TNF) therapies.
About the REFLEX study
The REFLEX study (Randomised Evaluation oF Long-term Efficacy of MabThera in RA) is a multi-centre, randomized, double-blind, placebo-controlled Phase III study. In this trial, patients who received a single course of only two infusions of MabThera with a stable dose of methotrexate (MTX) displayed a statistically significant improvement in symptoms measured at 24 weeks, compared to those receiving placebo and MTX. Patients receiving additional courses did so between 6 and 12 months after the initial course. Consistent with previous findings, analysis of the REFLEX 56-week data did not reveal any unexpected safety signals. The companies continue to monitor the long-term safety of rituximab in all clinical trials.
A further phase III development programme for MabThera therapy in patients with rheumatoid arthritis who have had an inadequate response to disease modifying anti-rheumatic drugs (DMARDs) is ongoing.
Long term safety and repeated courses
Further new data of a pooled analysis presented at EULAR confirmed the safety profile of rituximab identified in the original randomised clinical trials. The analysis included all RA patients treated with MabThera during clinical development which amounted to over 1,600 patient years with some patients being followed for over 3 years, many of whom had received multiple courses of treatment. This analysis did not reveal any unexpected safety signals.
About MabThera in rheumatoid arthritis
MabThera selectively targets a subset of B cells that express CD20, leaving stem, pro-B and plasma cells unaffected. This subset of B cells plays a key role in the autoimmune process of RA and MabThera aims to interrupt this process by inhibiting a series of reactions inflaming the synovia and leading to cartilage loss and bone erosion that is characteristic of the disease. More than 1,000 patients with RA have been treated with MabThera in clinical trials to date. A comprehensive Phase III clinical development programme is also currently underway to further investigate the potential clinical benefit of MabThera in earlier RA.
About Roche
Headquartered in Basel, Switzerland, Roche is one of the world's leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As a supplier of innovative products and services for the early detection, prevention, diagnosis and treatment of disease, the Group contributes on a broad range of fronts to improving people's health and quality of life. Roche is a world leader in diagnostics, the leading supplier of medicines for cancer and transplantation and a market leader in virology. In 2005, sales by the Pharmaceuticals Division totalled 27.3 billion Swiss francs, and the Diagnostics Division posted sales of 8.2 billion Swiss francs. Roche employs roughly 70,000 people in 150 countries and has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai. Additional information about the Roche Group is available on the Internet (roche).
All trademarks used or mentioned in this release are legally protected.
EULAR:
eular
British Society for Rheumatology:
rheumatology.uk
American College of Rheumatology:
rheumatology
Genentech:
gene
BiogenIdec:
biogenidec.
View drug information on Rituxan.
Damage to the structure of the joints ultimately causes destruction of the joints and contributes to joint deformity and loss of mobility. Patients' ability to work and perform every day tasks such as getting dressed, walking and eating can be severely hampered.
Presenting the results, Professor Keystone, Rheumatology Department at the University of Toronto, Canada, said: "This is the first evidence demonstrating that MabThera can inhibit structural joint damage in patients with an inadequate response to one or more TNF inhibitors. Preventing structural damage is a critical outcome in treating rheumatoid arthritis. These X-ray data confirm MabThera as an effective and innovative therapy for patients with rheumatoid arthritis and highlight the value of targeting B cells."
Repeat treatment courses
Additional new data presented at EULAR demonstrate that repeat courses of MabThera in RA patients, 6 to 12 months after the initial course, provide continued improvement of symptoms across all clinical measures. Each treatment course consists of two infusions of 1000mg given two weeks apart. The challenging goal of treatment in RA is remission and, following a second course of MabThera in patients with an inadequate response to one or more TNF inhibitors, the number of patients achieving remission doubled from 6 % following an initial course to 13 % following a second course. A similar trend was seen for those achieving the hard-to-reach goal of a 70 % improvement in symptoms (ACR70), with responses increasing from 12 % following an initial course to 21 % following a second course.
Patient perspectives
Importantly, data presented at EULAR show improvements in clinical scores are reflected in patient reported outcomes.
"While it is important to a physician to address a disease from a clinical perspective, what matters most to the patient is whether they are able to function normally and how well they feel. For example, the impact of fatigue is often underestimated, but this is something which really impacts patients' lives. MabThera has demonstrated continuous improvements in physical and mental health aspects with repeated courses of therapy", said Professor Tak, Director, Division of Clinical Immunology and Rheumatology at the Academic Medical Centre/University of Amsterdam, The Netherlands.
Approval Status
On 2 June 2006 MabThera received a recommendation for approval from the Committee for Medicinal Products for Human Use (CHMP) for the treatment of rheumatoid arthritis (RA) in Europe. MabThera, in combination with methotrexate, has been recommended for the treatment of adult patients with severe active rheumatoid arthritis who have had an inadequate response or intolerance to other disease-modifying anti-rheumatic drugs (DMARDs). On 28 February 2006, after priority review, Genentech and Biogen Idec received US approval for Rituxan (rituximab in the US) for the treatment of adult patients with moderately to severely active RA in combination with methotrexate for reducing signs and symptoms in those RA patients who have had an inadequate response to one or more tumour necrosis factor (TNF) therapies.
About the REFLEX study
The REFLEX study (Randomised Evaluation oF Long-term Efficacy of MabThera in RA) is a multi-centre, randomized, double-blind, placebo-controlled Phase III study. In this trial, patients who received a single course of only two infusions of MabThera with a stable dose of methotrexate (MTX) displayed a statistically significant improvement in symptoms measured at 24 weeks, compared to those receiving placebo and MTX. Patients receiving additional courses did so between 6 and 12 months after the initial course. Consistent with previous findings, analysis of the REFLEX 56-week data did not reveal any unexpected safety signals. The companies continue to monitor the long-term safety of rituximab in all clinical trials.
A further phase III development programme for MabThera therapy in patients with rheumatoid arthritis who have had an inadequate response to disease modifying anti-rheumatic drugs (DMARDs) is ongoing.
Long term safety and repeated courses
Further new data of a pooled analysis presented at EULAR confirmed the safety profile of rituximab identified in the original randomised clinical trials. The analysis included all RA patients treated with MabThera during clinical development which amounted to over 1,600 patient years with some patients being followed for over 3 years, many of whom had received multiple courses of treatment. This analysis did not reveal any unexpected safety signals.
About MabThera in rheumatoid arthritis
MabThera selectively targets a subset of B cells that express CD20, leaving stem, pro-B and plasma cells unaffected. This subset of B cells plays a key role in the autoimmune process of RA and MabThera aims to interrupt this process by inhibiting a series of reactions inflaming the synovia and leading to cartilage loss and bone erosion that is characteristic of the disease. More than 1,000 patients with RA have been treated with MabThera in clinical trials to date. A comprehensive Phase III clinical development programme is also currently underway to further investigate the potential clinical benefit of MabThera in earlier RA.
About Roche
Headquartered in Basel, Switzerland, Roche is one of the world's leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As a supplier of innovative products and services for the early detection, prevention, diagnosis and treatment of disease, the Group contributes on a broad range of fronts to improving people's health and quality of life. Roche is a world leader in diagnostics, the leading supplier of medicines for cancer and transplantation and a market leader in virology. In 2005, sales by the Pharmaceuticals Division totalled 27.3 billion Swiss francs, and the Diagnostics Division posted sales of 8.2 billion Swiss francs. Roche employs roughly 70,000 people in 150 countries and has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai. Additional information about the Roche Group is available on the Internet (roche).
All trademarks used or mentioned in this release are legally protected.
EULAR:
eular
British Society for Rheumatology:
rheumatology.uk
American College of Rheumatology:
rheumatology
Genentech:
gene
BiogenIdec:
biogenidec.
View drug information on Rituxan.
четверг, 9 июня 2011 г.
Protelos(reg) significantly reduces hip fracture risk in osteoporotic postmenopausal women, Laboratoires Servier
Results of a major new study, published on-line today in the Journal of Clinical Endocrinology and Metabolism, show that
a novel treatment for osteoporosis, Protelos(reg) (S12911, strontium ranelate), significantly reduces the risk of hip fractures
in osteoporotic postmenopausal women.1
Protelos(reg) information for health care
professionals.
The TReatment Of Peripheral OSteoporosis (TROPOS) study, a large international randomised, placebo-controlled clinical
trial, found that Protelos(reg) reduced the risk of hip fractures, the most debilitating form of fracture, by 36 per cent
(P=0.046) in postmenopausal osteoporotic women over a three-year period. Protelos(reg) also significantly reduced the risk of all
peripheral fractures and major peripheral fractures. The TROPOS study also confirmed the efficacy of Protelos(reg) against new
vertebral fracture shown in a previous phase III study.2 In addition it demonstrated that Protelos(reg) is effective in less
severe patients (those without previous vertebral fractures) reducing their risk of vertebral fracture by 45 per cent over 3
years (P
Protelos(reg) information for health care
professionals.
References:
1 - Reginster JY, Seeman E, De Vernejoul, et al. Strontium ranelate reduces the risk of nonvertebral fractures in
post-menopausal women with osteoporosis:TROPOS Study . JCEM Rapid Electronic Publication. February 2005.
2 - Meunier PJ, Roux C, Seeman E, et al. The effects of strontium ranelate on the risk of vertebral fracture in women with
postmenopausal osteoporosis. N Engl J Med.2004;350:459-468.
3 - Marie PJ, Ammann P, Boivin G, et al. Mechanisms of action and therapeutic potential of strontium in bone. Calcif Tissue
Int. 2001;69:121-129.
4 - European Summary of Product Characteristics.
5 - Ammann P, Shen V, Robin B, et al. Strontium ranelate improves bone resistance by increasing bone mass and improving
architecture in intact female rats.J Bone Miner Res 2004;19 (12). 2012-2020.
OSTEOPOROSIS
BACKGROUND INFORMATION
Osteoporosis is a bone disease characterized by bone fragility due to low bone mass and changes in internal bone structure.
This results in an increase in the susceptibility to fractures occurring after minor trauma. Osteoporosis primarily affects
women.
What causes osteoporosis?
Human bone is constantly undergoing a remodeling process, in which bone is removed and reformed. Two types of cells mediate
this process; osteoblasts are responsible for creating the bone matrix and mineralizing bone, and osteoclasts for resorbing
bone. However, if the body begins to resorb bone faster than new bone is produced then over a period of time there is a
decrease in bone mass and osteoporosis occurs.
Following the menopause, there is an oestrogen deficiency as a result of a loss of oestrogen production by the ovaries, which
is associated with an increased rate of bone turnover and an accelerated rate of bone loss [1]. This accelerated bone loss
induces a decrease in bone mass and an increased incidence of fractures [2].
How common is osteoporosis?
It is difficult to assess the prevalence of osteoporosis because the majority of osteoporosis cases are undiagnosed [3].
Although osteoporosis can strike at any age, the incidence of fractures increases exponentially with age. About 40% of women
aged 50 years are predicted to sustain at least one fracture in the remainder of lifetime, of whom 20% are expected to suffer
from multiple fractures [4].
Hip fractures
The incidence of hip fractures rises exponentially with age in most parts of the world [5] with the incidence rising
dramatically around 74 years of age [6]. Most hip fractures result from a fall from standing height (or lower) in women with
low bone strength [7]. Aging increases the number of falls, which are caused by slipping or stumbling and loss of balance;
furthermore, women experience more falls than men [8].
Hip fractures are associated with an overall mortality of 15% to 30%, most of the excess deaths occurring within the first 6
months after the fracture [9]. Hip fractures are associated with high morbidity requiring a mean hospital stay of 20 to 30
days, and more than 30% of women who have had a hip fracture loose their independence. The number of hip fractures worldwide
are projected to increase almost fourfold from 1990 to 2050.
Vertebral fractures
Unlike hip fractures, vertebral fractures are difficult to diagnose. Seventy-five per cent of vertebral fractures occur
without any trauma, after an everyday action such as bending or getting up, with less than a quarter resulting from falls.
The majority of vertebral fractures are asymptomatic, and remain undiagnosed. Vertebral fractures produce serious
consequences, such as long-term pain, deformities, loss of height, and related physical disability, and have a considerable
impact on quality of life. Although many fractures occur without any pain, substantial back deformities can lead not only to
functional difficulties but also to psychological concerns such as loss of self-esteem and depressive states.
References:
1 - Parfitt AM. Age-related structural changes in trabecular and cortical bone: Cellular mechanisms and biochemical
consequences. Calcif Tissue Int. 1984;36:S123-S128.
2 - Riggs BL, Melton III LJ. Involutional osteoporosis. N Engl J Med. 1998;314:1676-1686.
3 - Norman P. Outlook for the osteoporosis market to 2005. SPECTRUM therapy markets and emerging technologies. Decision
Resources; 2001.
4 - Doherty DA, Sanders KM, Kotowicz MA, Prince RL. Lifetime and five-year age-specific risks of first and subsequent
osteoporotic fractures in postmenopausal women. Osteoporos Int. 2001;12:16-23.
5 - Johnell O, Gullberg B, Allander E, Kanis JA. The apparent incidence of hip fracture in Europe: a study of national
register sources. MEDOS Study Group. Osteoporos Int. 1992; 2:298-302.
6 - Donaldson LJ, Cook A, Thomson RG, et al. Incidence of fractures in a geographically defined population. J Epidemiol
Community Health. 1990;44:241-245
7 - Cummings SR, Melton LJ (2002) Epidemiology and outcomes of osteoporotic fractures. Lancet 359:1761-7.
8 - Cooper C. Epidemiology of osteoporosis. Osteoporos Int. 1999; 9(Suppl 2):S2-8.
9 - Report on osteoporosis in the European Community. Action for prevention. European Communities, 1998.
Protelos(reg) information for health care
professionals.
For further information, please contact:
Stephanie Makin
Tonic Life Communications
Tel: +44 20 7798 9905
E-mail: stephanie.makintoniclc
a novel treatment for osteoporosis, Protelos(reg) (S12911, strontium ranelate), significantly reduces the risk of hip fractures
in osteoporotic postmenopausal women.1
Protelos(reg) information for health care
professionals.
The TReatment Of Peripheral OSteoporosis (TROPOS) study, a large international randomised, placebo-controlled clinical
trial, found that Protelos(reg) reduced the risk of hip fractures, the most debilitating form of fracture, by 36 per cent
(P=0.046) in postmenopausal osteoporotic women over a three-year period. Protelos(reg) also significantly reduced the risk of all
peripheral fractures and major peripheral fractures. The TROPOS study also confirmed the efficacy of Protelos(reg) against new
vertebral fracture shown in a previous phase III study.2 In addition it demonstrated that Protelos(reg) is effective in less
severe patients (those without previous vertebral fractures) reducing their risk of vertebral fracture by 45 per cent over 3
years (P
Protelos(reg) information for health care
professionals.
References:
1 - Reginster JY, Seeman E, De Vernejoul, et al. Strontium ranelate reduces the risk of nonvertebral fractures in
post-menopausal women with osteoporosis:TROPOS Study . JCEM Rapid Electronic Publication. February 2005.
2 - Meunier PJ, Roux C, Seeman E, et al. The effects of strontium ranelate on the risk of vertebral fracture in women with
postmenopausal osteoporosis. N Engl J Med.2004;350:459-468.
3 - Marie PJ, Ammann P, Boivin G, et al. Mechanisms of action and therapeutic potential of strontium in bone. Calcif Tissue
Int. 2001;69:121-129.
4 - European Summary of Product Characteristics.
5 - Ammann P, Shen V, Robin B, et al. Strontium ranelate improves bone resistance by increasing bone mass and improving
architecture in intact female rats.J Bone Miner Res 2004;19 (12). 2012-2020.
OSTEOPOROSIS
BACKGROUND INFORMATION
Osteoporosis is a bone disease characterized by bone fragility due to low bone mass and changes in internal bone structure.
This results in an increase in the susceptibility to fractures occurring after minor trauma. Osteoporosis primarily affects
women.
What causes osteoporosis?
Human bone is constantly undergoing a remodeling process, in which bone is removed and reformed. Two types of cells mediate
this process; osteoblasts are responsible for creating the bone matrix and mineralizing bone, and osteoclasts for resorbing
bone. However, if the body begins to resorb bone faster than new bone is produced then over a period of time there is a
decrease in bone mass and osteoporosis occurs.
Following the menopause, there is an oestrogen deficiency as a result of a loss of oestrogen production by the ovaries, which
is associated with an increased rate of bone turnover and an accelerated rate of bone loss [1]. This accelerated bone loss
induces a decrease in bone mass and an increased incidence of fractures [2].
How common is osteoporosis?
It is difficult to assess the prevalence of osteoporosis because the majority of osteoporosis cases are undiagnosed [3].
Although osteoporosis can strike at any age, the incidence of fractures increases exponentially with age. About 40% of women
aged 50 years are predicted to sustain at least one fracture in the remainder of lifetime, of whom 20% are expected to suffer
from multiple fractures [4].
Hip fractures
The incidence of hip fractures rises exponentially with age in most parts of the world [5] with the incidence rising
dramatically around 74 years of age [6]. Most hip fractures result from a fall from standing height (or lower) in women with
low bone strength [7]. Aging increases the number of falls, which are caused by slipping or stumbling and loss of balance;
furthermore, women experience more falls than men [8].
Hip fractures are associated with an overall mortality of 15% to 30%, most of the excess deaths occurring within the first 6
months after the fracture [9]. Hip fractures are associated with high morbidity requiring a mean hospital stay of 20 to 30
days, and more than 30% of women who have had a hip fracture loose their independence. The number of hip fractures worldwide
are projected to increase almost fourfold from 1990 to 2050.
Vertebral fractures
Unlike hip fractures, vertebral fractures are difficult to diagnose. Seventy-five per cent of vertebral fractures occur
without any trauma, after an everyday action such as bending or getting up, with less than a quarter resulting from falls.
The majority of vertebral fractures are asymptomatic, and remain undiagnosed. Vertebral fractures produce serious
consequences, such as long-term pain, deformities, loss of height, and related physical disability, and have a considerable
impact on quality of life. Although many fractures occur without any pain, substantial back deformities can lead not only to
functional difficulties but also to psychological concerns such as loss of self-esteem and depressive states.
References:
1 - Parfitt AM. Age-related structural changes in trabecular and cortical bone: Cellular mechanisms and biochemical
consequences. Calcif Tissue Int. 1984;36:S123-S128.
2 - Riggs BL, Melton III LJ. Involutional osteoporosis. N Engl J Med. 1998;314:1676-1686.
3 - Norman P. Outlook for the osteoporosis market to 2005. SPECTRUM therapy markets and emerging technologies. Decision
Resources; 2001.
4 - Doherty DA, Sanders KM, Kotowicz MA, Prince RL. Lifetime and five-year age-specific risks of first and subsequent
osteoporotic fractures in postmenopausal women. Osteoporos Int. 2001;12:16-23.
5 - Johnell O, Gullberg B, Allander E, Kanis JA. The apparent incidence of hip fracture in Europe: a study of national
register sources. MEDOS Study Group. Osteoporos Int. 1992; 2:298-302.
6 - Donaldson LJ, Cook A, Thomson RG, et al. Incidence of fractures in a geographically defined population. J Epidemiol
Community Health. 1990;44:241-245
7 - Cummings SR, Melton LJ (2002) Epidemiology and outcomes of osteoporotic fractures. Lancet 359:1761-7.
8 - Cooper C. Epidemiology of osteoporosis. Osteoporos Int. 1999; 9(Suppl 2):S2-8.
9 - Report on osteoporosis in the European Community. Action for prevention. European Communities, 1998.
Protelos(reg) information for health care
professionals.
For further information, please contact:
Stephanie Makin
Tonic Life Communications
Tel: +44 20 7798 9905
E-mail: stephanie.makintoniclc
среда, 8 июня 2011 г.
Two Studies Indicate Coblation(R) Safely Treats Symptomatic Chondral Defects In The Knee
Two new studies show
Coblation(R) devices were effective for safely treating symptomatic
chondral defects in the knee. The two studies were presented at the
Arthroscopic Association of North America (AANA) annual meeting held May 18
to 21 at the Westin Diplomat Resort & Spa, Hollywood, Florida.
Coblation is a patented technology (ArthroCare Corp. Nasdaq: ARTC) that
combines bipolar radiofrequency energy with a saline solution to gently and
precisely remove soft tissue at low temperatures, typically 40 to 70
degrees Celsius.
The first study, presented by Ferdinando Battistella, MD, orthopaedic
surgeon at Legano Hospital (Milan, Italy) is the first clinical study to
evaluate in vivo histologic findings after the use of bipolar
radiofrequency-based methods in articular cartilage of the knee. Results of
the study indicate this approach can be used to safely treat grades II and
III lesions in the knee.
"The cells in the tissue surrounding the treated area were healthy
months after the procedure, which may decrease the chance of long term
degeneration," said Battistella, lead author of the study titled: In Vivo
Histology Findings Through One Year After Clinical Use of Bipolar
Radiofrequency-Based Chondroplasty. "These findings are significant for
orthopaedic surgeons as I have also found Coblation is easy to use and
produces a smoother surface than a mechanical shaver during the debridement
of articular cartilage."
The study, conducted in Italy, included four patients awaiting total
knee replacement who were treated with arthroscopic chondroplasty using
Coblation. Second-look arthroscopy of treated defects in patients at six,
nine and 12 months following the procedure appeared viable and stable, with
no evidence of deterioration.
A second study, Osteonecrosis Following Arthroscopic Chondroplasty -- a
Retrospective Evaluation of 521 Patients Who Underwent Arthroscopic Knee
Surgery -- indicated no relationship between the onset of osteonecrosis and
the type of surgical device used for treating symptomatic chondral defects
in the knee. The study was presented by Dain Allred, MD, orthopaedic
surgeon at the University of Rochester School of Medicine.
Of the 521 patients receiving arthroscopic knee surgery and treatment
of chondral defects using Coblation alone, a mechanical shaver alone, or
both Coblation and a mechanical shaver, there were no cases of
osteonecrosis among the 52 people treated with Coblation alone. The rate of
osteonecrosis following chondroplasty with a mechanical shaver was 0.98
percent (2 out of 205 people), and among those who were treated using both
methods, the rate of osteonecrosis was 1.2 percent (3 out of 259 people).
For more information about bipolar radio frequency-based Coblation
Visit arthrocare.
ABOUT ARTHROCARE
Founded in 1993, ArthroCare Corp. ( arthrocare ) is a highly
innovative, multi-business medical device company that develops,
manufactures and markets minimally invasive surgical products. With these
products, ArthroCare targets a multi-billion dollar market opportunity
across several medical specialties, significantly improving existing
surgical procedures and enabling new, minimally invasive procedures. Many
of ArthroCare's products are based on its patented Coblation technology,
which uses low-temperature radiofrequency energy to gently and precisely
dissolve rather than burn soft tissue -- minimizing damage to healthy
tissue. Used in more than four million surgeries worldwide, Coblation-based
devices have been developed and marketed for sports medicine;
spine/neurologic; ear, nose and throat (ENT); cosmetic; urologic and
gynecologic procedures. ArthroCare also has added a number of novel
technologies to its portfolio, including Opus Medical sports medicine,
Parallax spine and Applied Therapeutics ENT products, to complement
Coblation within key indications.
SAFE HARBOR STATEMENTS
Except for historical information, this press release includes
forward-looking statements. These statements include, but are not limited
to, the company's stated business outlook for fiscal 2006 and 2007,
continued strength of the company's fundamental position, the strength of
the company's technology, the company's belief that strategic moves will
enhance achievement of the company's long term potential, the potential and
expected rate of growth of new businesses, continued success of product
diversification efforts, and other statements that involve risks and
uncertainties. These risks and uncertainties include, but are not limited
to the uncertainty of success of the company's non-arthroscopic products,
competitive risk, uncertainty of the success of strategic business
alliances, uncertainty over reimbursement, need for governmental clearances
or approvals before selling products, the uncertainty of protecting the
company's patent position, and any changes in financial results from
completion of year-end audit activities. These and other risks and
uncertainties are detailed from time to time in the company's Securities
and Exchange Commission filings, including ArthroCare's Form 10-Q for the
quarter ended Sept. 30, 2005 and Form 10-K for the year ended Dec. 31,
2005. Forward-looking statements are indicated by words or phrases such as
"anticipates," "estimates," "projects," "believes," "intends," "expects,"
and similar words and phrases. Actual results may differ materially from
management expectations.
ArthroCare Corp.
arthrocare
Coblation(R) devices were effective for safely treating symptomatic
chondral defects in the knee. The two studies were presented at the
Arthroscopic Association of North America (AANA) annual meeting held May 18
to 21 at the Westin Diplomat Resort & Spa, Hollywood, Florida.
Coblation is a patented technology (ArthroCare Corp. Nasdaq: ARTC) that
combines bipolar radiofrequency energy with a saline solution to gently and
precisely remove soft tissue at low temperatures, typically 40 to 70
degrees Celsius.
The first study, presented by Ferdinando Battistella, MD, orthopaedic
surgeon at Legano Hospital (Milan, Italy) is the first clinical study to
evaluate in vivo histologic findings after the use of bipolar
radiofrequency-based methods in articular cartilage of the knee. Results of
the study indicate this approach can be used to safely treat grades II and
III lesions in the knee.
"The cells in the tissue surrounding the treated area were healthy
months after the procedure, which may decrease the chance of long term
degeneration," said Battistella, lead author of the study titled: In Vivo
Histology Findings Through One Year After Clinical Use of Bipolar
Radiofrequency-Based Chondroplasty. "These findings are significant for
orthopaedic surgeons as I have also found Coblation is easy to use and
produces a smoother surface than a mechanical shaver during the debridement
of articular cartilage."
The study, conducted in Italy, included four patients awaiting total
knee replacement who were treated with arthroscopic chondroplasty using
Coblation. Second-look arthroscopy of treated defects in patients at six,
nine and 12 months following the procedure appeared viable and stable, with
no evidence of deterioration.
A second study, Osteonecrosis Following Arthroscopic Chondroplasty -- a
Retrospective Evaluation of 521 Patients Who Underwent Arthroscopic Knee
Surgery -- indicated no relationship between the onset of osteonecrosis and
the type of surgical device used for treating symptomatic chondral defects
in the knee. The study was presented by Dain Allred, MD, orthopaedic
surgeon at the University of Rochester School of Medicine.
Of the 521 patients receiving arthroscopic knee surgery and treatment
of chondral defects using Coblation alone, a mechanical shaver alone, or
both Coblation and a mechanical shaver, there were no cases of
osteonecrosis among the 52 people treated with Coblation alone. The rate of
osteonecrosis following chondroplasty with a mechanical shaver was 0.98
percent (2 out of 205 people), and among those who were treated using both
methods, the rate of osteonecrosis was 1.2 percent (3 out of 259 people).
For more information about bipolar radio frequency-based Coblation
Visit arthrocare.
ABOUT ARTHROCARE
Founded in 1993, ArthroCare Corp. ( arthrocare ) is a highly
innovative, multi-business medical device company that develops,
manufactures and markets minimally invasive surgical products. With these
products, ArthroCare targets a multi-billion dollar market opportunity
across several medical specialties, significantly improving existing
surgical procedures and enabling new, minimally invasive procedures. Many
of ArthroCare's products are based on its patented Coblation technology,
which uses low-temperature radiofrequency energy to gently and precisely
dissolve rather than burn soft tissue -- minimizing damage to healthy
tissue. Used in more than four million surgeries worldwide, Coblation-based
devices have been developed and marketed for sports medicine;
spine/neurologic; ear, nose and throat (ENT); cosmetic; urologic and
gynecologic procedures. ArthroCare also has added a number of novel
technologies to its portfolio, including Opus Medical sports medicine,
Parallax spine and Applied Therapeutics ENT products, to complement
Coblation within key indications.
SAFE HARBOR STATEMENTS
Except for historical information, this press release includes
forward-looking statements. These statements include, but are not limited
to, the company's stated business outlook for fiscal 2006 and 2007,
continued strength of the company's fundamental position, the strength of
the company's technology, the company's belief that strategic moves will
enhance achievement of the company's long term potential, the potential and
expected rate of growth of new businesses, continued success of product
diversification efforts, and other statements that involve risks and
uncertainties. These risks and uncertainties include, but are not limited
to the uncertainty of success of the company's non-arthroscopic products,
competitive risk, uncertainty of the success of strategic business
alliances, uncertainty over reimbursement, need for governmental clearances
or approvals before selling products, the uncertainty of protecting the
company's patent position, and any changes in financial results from
completion of year-end audit activities. These and other risks and
uncertainties are detailed from time to time in the company's Securities
and Exchange Commission filings, including ArthroCare's Form 10-Q for the
quarter ended Sept. 30, 2005 and Form 10-K for the year ended Dec. 31,
2005. Forward-looking statements are indicated by words or phrases such as
"anticipates," "estimates," "projects," "believes," "intends," "expects,"
and similar words and phrases. Actual results may differ materially from
management expectations.
ArthroCare Corp.
arthrocare
вторник, 7 июня 2011 г.
Key Gene May Increase Osteoarthritis Risk
Japanese scientists from the Institute of Physical and Chemical Research say a key mutant gene seems to raise the risk of
osteoarthritis. The gene is a mutant form of asporin. According to the scientists, the more severe your osteoarthritis is,
the more likely you are to have this mutant asporin gene.
You can read about this study in the journal Nature Genetics.
If your body produces new cartilage at a slower rate than it is losing it, the unprotected ends of bones rub together and
cause inflammation.
The researchers say that asporin plays a role in balancing the production of new cartilage to the loss of it.
It is estimated that 5% of adults suffer from osteoarthritis.
osteoarthritis. The gene is a mutant form of asporin. According to the scientists, the more severe your osteoarthritis is,
the more likely you are to have this mutant asporin gene.
You can read about this study in the journal Nature Genetics.
If your body produces new cartilage at a slower rate than it is losing it, the unprotected ends of bones rub together and
cause inflammation.
The researchers say that asporin plays a role in balancing the production of new cartilage to the loss of it.
It is estimated that 5% of adults suffer from osteoarthritis.
Compliance Essential In Osteoporosis Treatment
Women who do not comply with treatment instructions for osteoporosis or who do not respond to treatment are more likely to suffer further fractures, which seriously affects their quality of life. There is an urgent need to provide support to these patients and address their issues when new therapies are assessed and new treatment guidelines drawn up, according to lead researcher Professor Cyrus Cooper from the MRC Epidemiology Resource Centre, University of Southampton, in the UK. His findings (1) will be published in the April issue of Osteoporosis International, a Springer journal.
Osteoporosis is an increasing global health problem and currently available therapies have been shown to reduce the risk of fragility fractures in postmenopausal women. Most patients gain bone mineral density within a year of treatment. However, surveys of osteoporotic patients show that compliance to treatment is low in practice, and up to 50% of patients stop their treatment within a year due in part to side-effects. In addition, clinical trials show that osteoporotic fractures have physical, psychological and social implications that can seriously affect patients' quality of life.
Cooper and colleagues' study, the Observational Study of Severe Osteoporosis (OSSO)*, looked at the number of fractures suffered by women who did not respond to drug therapy, and how treatment failure affected their health-related quality of life. A total of 1,885 70-year-old women with established osteoporosis and 'inadequate clinical response to osteoporosis drug therapy' were assessed over a year. The researchers used a combination of two questionnaires to measure their quality of life at the start of the study, and then after six months and after a year. 'Inadequate clinical response to osteoporosis drug therapy' is defined as either a fragility fracture despite therapy for one year, or discontinued drug treatment due to adverse effects and/or noncompliance.
A total of 209 fractures occurred in 166 women over the year. Women who had suffered fractures in the past were more likely to sustain a new fracture than those who had not. Quality of life scores were worse in women who suffered a fracture regardless of whether they had had a fracture in the past. General health perception, social function and pain were the worst rated quality of life measures.
These findings show that the risk of fracture is high in women after failed osteoporosis therapy and the presence of a previous fracture in the previous 12 months strongly predicts a fracture in the next 12 months. The improvement in quality of life in the absence of fractures was significant, indicating the need for effective treatments for patients with osteoporosis.
*OSSO was a multi-national, 12-month prospective observational study across 469 out-patient settings in six European countries: France, Germany, Greece, Portugal, Spain and the UK. Women were recruited between April 2003 and June 2004.
Reference
1. Cooper C et al (2008). Fracture incidence and changes in quality of life in women with an inadequate clinical outcome from osteoporosis therapy: the Observational Study of Severe Osteoporosis (OSSO). Osteoporosis International (DOI 10.1007/s00198-007-0488-8)
Source: Joan Robinson
Springer
Osteoporosis is an increasing global health problem and currently available therapies have been shown to reduce the risk of fragility fractures in postmenopausal women. Most patients gain bone mineral density within a year of treatment. However, surveys of osteoporotic patients show that compliance to treatment is low in practice, and up to 50% of patients stop their treatment within a year due in part to side-effects. In addition, clinical trials show that osteoporotic fractures have physical, psychological and social implications that can seriously affect patients' quality of life.
Cooper and colleagues' study, the Observational Study of Severe Osteoporosis (OSSO)*, looked at the number of fractures suffered by women who did not respond to drug therapy, and how treatment failure affected their health-related quality of life. A total of 1,885 70-year-old women with established osteoporosis and 'inadequate clinical response to osteoporosis drug therapy' were assessed over a year. The researchers used a combination of two questionnaires to measure their quality of life at the start of the study, and then after six months and after a year. 'Inadequate clinical response to osteoporosis drug therapy' is defined as either a fragility fracture despite therapy for one year, or discontinued drug treatment due to adverse effects and/or noncompliance.
A total of 209 fractures occurred in 166 women over the year. Women who had suffered fractures in the past were more likely to sustain a new fracture than those who had not. Quality of life scores were worse in women who suffered a fracture regardless of whether they had had a fracture in the past. General health perception, social function and pain were the worst rated quality of life measures.
These findings show that the risk of fracture is high in women after failed osteoporosis therapy and the presence of a previous fracture in the previous 12 months strongly predicts a fracture in the next 12 months. The improvement in quality of life in the absence of fractures was significant, indicating the need for effective treatments for patients with osteoporosis.
*OSSO was a multi-national, 12-month prospective observational study across 469 out-patient settings in six European countries: France, Germany, Greece, Portugal, Spain and the UK. Women were recruited between April 2003 and June 2004.
Reference
1. Cooper C et al (2008). Fracture incidence and changes in quality of life in women with an inadequate clinical outcome from osteoporosis therapy: the Observational Study of Severe Osteoporosis (OSSO). Osteoporosis International (DOI 10.1007/s00198-007-0488-8)
Source: Joan Robinson
Springer
понедельник, 6 июня 2011 г.
New Spine Fusion Indication for Recombinant Protein Treatment
Wyeth and Astellas BV, today announced that the European Commission has approved InductOs™ (rhBMP-2/ACS) [recombinant
human Bone Morphogenetic Protein-2/Absorbable Collagen Sponge] for the treatment of single level (L4-S1) anterior lumbar
spine fusions as a substitute for autogenous bone graft in adults with degenerative disc disease who have had at least six
months of nonoperative treatment for this condition. InductOs has been approved by the European authorities since 2002 for
the treatment of acute tibia fractures in adults, as an adjunct to standard care using open fracture reduction and
intramedullary nail fixation.
Degenerative disc disease is a leading cause of lower back pain and one of the most prevalent health problems in the world.
Nonoperative forms of treatment fail to provide sufficient relief from pain and disability for many patients. For them,
fusion of the involved spinal segments, and often anterior lumbar interbody spine fusion using autogenous bone with interbody
fusion cages, is considered a viable course of action.
"With InductOs, surgeons can now offer EU patients an alternative to painful autogenous bone harvesting," said Joseph
Camardo, M.D., Senior Vice President of Global Medical Affairs and Medical Director for Wyeth Pharmaceuticals North America.
"The potential benefit for the patient is relief from the symptoms of degenerative disc disease without the additional pain
and morbidity associated with autograft harvesting."
InductOs contains recombinant human Bone Morphogenetic Protein-2 (rhBMP-2, or dibotermin alfa), a recombinant version of a
naturally occurring human protein that was discovered and developed by Wyeth Pharmaceuticals. The protein is manufactured at
a Wyeth biopharmaceutical facility in Andover, Massachusetts.
The EMEA approval was based on data from a randomized multicenter study of 279 patients undergoing an open anterior lumbar
fusion procedure. At 24 months postoperation, results in terms of predetermined overall success, pain and disability, and
radiologic fusion were comparable between the patient group treated with InductOs and the patient group treated with
autologous bone fusion.
Like all medicines, InductOs may have side effects. The undesirable effects observed in anterior lumbar spine fusion
patients were generally representative of the morbidity associated with spine fusion using autogenous bone graft taken from
the iliac crest. Very common (>10 percent) undesirable effects such as accidental injury, neuralgia, back pain and bone
disorder, were similar in both control and InductOs treatment groups. In spinal fusion studies 0.7 percent of patients
receiving InductOs developed antibodies to rhBMP-2 vs. 0.8 percent of patients receiving bone grafts; in addition 19 percent
of patients receiving InductOs developed antibodies to bovine Type I collagen vs. 13 percent of patients receiving autogenous
bone graft.
Wyeth Pharmaceuticals and Astellas BV, a subsidiary of Astellas Pharma Inc., are partners in the development and
commercialization of BMP products in Europe. Medtronic Sofamor Danek (MSD), the spinal business of Medtronic (NYSE: MDT),
has the exclusive promotion rights for InductOs in Europe for certain indications, including acute tibial fractures and
spinal fusion.
About Wyeth Pharmaceuticals
Wyeth Pharmaceuticals, a division of Wyeth, has leading products in the areas of women's health care, cardiovascular disease,
central nervous system, inflammation, transplantation, hemophilia, oncology, vaccines and nutritional products. Wyeth is one
of the world's largest research-driven pharmaceutical and health care products companies. It is a leader in the discovery,
development, manufacturing, and marketing of pharmaceuticals, vaccines, biotechnology products and nonprescription medicines
that improve the quality of life for people worldwide. The Company's major divisions include Wyeth Pharmaceuticals, Wyeth
Consumer Healthcare, and Fort Dodge Animal Health.
About Astellas
Astellas Pharma Europe BV is a subsidiary of Astellas Pharma Inc., located in Tokyo, a pharmaceutical company dedicated to
improving the health of people around the world through the provision of innovative and reliable pharmaceutical products. In
April 2005, the company was formed through the merger of Fujisawa Pharmaceutical Co., Ltd. and Yamanouchi Pharmaceutical Co.,
Ltd. The organization is committed to becoming a global mega pharmaceutical company by combining outstanding R&D and
marketing capabilities and continuing to grow in the world pharmaceutical market.
The statements in this press release that are not historical facts are forward-looking statements based on current
expectations of future events that involve risks and uncertainties including, without limitation, risks associated with the
inherent uncertainty of the timing and success of pharmaceutical research, product development, manufacturing,
commercialization, economic conditions including interest and currency exchange rate fluctuations, changes in generally
accepted accounting principles, the impact of competitive or generic products, trade buying patterns, wars or terrorist acts,
product liability and other types of lawsuits, the impact of legislation and regulatory compliance and obtaining
reimbursement, favorable drug pricing, access and other approvals, environmental liabilities, and patent, and other risks and
uncertainties, including those detailed from time to time in the Company's periodic reports, including current reports on
Form 8-K, quarterly reports on Form 10-Q and the annual report on Form 10-K, filed with the Securities and Exchange
Commission. Actual results may vary materially from the forward-looking statements. The Company assumes no obligation to
publicly update any forward-looking statements, whether as a result of new information, future events or otherwise.
Media
Christopher Garland
Wyeth Pharmaceuticals
484-865-6323
Investor
Justin Victoria
Wyeth
973-660-5340
wyeth
human Bone Morphogenetic Protein-2/Absorbable Collagen Sponge] for the treatment of single level (L4-S1) anterior lumbar
spine fusions as a substitute for autogenous bone graft in adults with degenerative disc disease who have had at least six
months of nonoperative treatment for this condition. InductOs has been approved by the European authorities since 2002 for
the treatment of acute tibia fractures in adults, as an adjunct to standard care using open fracture reduction and
intramedullary nail fixation.
Degenerative disc disease is a leading cause of lower back pain and one of the most prevalent health problems in the world.
Nonoperative forms of treatment fail to provide sufficient relief from pain and disability for many patients. For them,
fusion of the involved spinal segments, and often anterior lumbar interbody spine fusion using autogenous bone with interbody
fusion cages, is considered a viable course of action.
"With InductOs, surgeons can now offer EU patients an alternative to painful autogenous bone harvesting," said Joseph
Camardo, M.D., Senior Vice President of Global Medical Affairs and Medical Director for Wyeth Pharmaceuticals North America.
"The potential benefit for the patient is relief from the symptoms of degenerative disc disease without the additional pain
and morbidity associated with autograft harvesting."
InductOs contains recombinant human Bone Morphogenetic Protein-2 (rhBMP-2, or dibotermin alfa), a recombinant version of a
naturally occurring human protein that was discovered and developed by Wyeth Pharmaceuticals. The protein is manufactured at
a Wyeth biopharmaceutical facility in Andover, Massachusetts.
The EMEA approval was based on data from a randomized multicenter study of 279 patients undergoing an open anterior lumbar
fusion procedure. At 24 months postoperation, results in terms of predetermined overall success, pain and disability, and
radiologic fusion were comparable between the patient group treated with InductOs and the patient group treated with
autologous bone fusion.
Like all medicines, InductOs may have side effects. The undesirable effects observed in anterior lumbar spine fusion
patients were generally representative of the morbidity associated with spine fusion using autogenous bone graft taken from
the iliac crest. Very common (>10 percent) undesirable effects such as accidental injury, neuralgia, back pain and bone
disorder, were similar in both control and InductOs treatment groups. In spinal fusion studies 0.7 percent of patients
receiving InductOs developed antibodies to rhBMP-2 vs. 0.8 percent of patients receiving bone grafts; in addition 19 percent
of patients receiving InductOs developed antibodies to bovine Type I collagen vs. 13 percent of patients receiving autogenous
bone graft.
Wyeth Pharmaceuticals and Astellas BV, a subsidiary of Astellas Pharma Inc., are partners in the development and
commercialization of BMP products in Europe. Medtronic Sofamor Danek (MSD), the spinal business of Medtronic (NYSE: MDT),
has the exclusive promotion rights for InductOs in Europe for certain indications, including acute tibial fractures and
spinal fusion.
About Wyeth Pharmaceuticals
Wyeth Pharmaceuticals, a division of Wyeth, has leading products in the areas of women's health care, cardiovascular disease,
central nervous system, inflammation, transplantation, hemophilia, oncology, vaccines and nutritional products. Wyeth is one
of the world's largest research-driven pharmaceutical and health care products companies. It is a leader in the discovery,
development, manufacturing, and marketing of pharmaceuticals, vaccines, biotechnology products and nonprescription medicines
that improve the quality of life for people worldwide. The Company's major divisions include Wyeth Pharmaceuticals, Wyeth
Consumer Healthcare, and Fort Dodge Animal Health.
About Astellas
Astellas Pharma Europe BV is a subsidiary of Astellas Pharma Inc., located in Tokyo, a pharmaceutical company dedicated to
improving the health of people around the world through the provision of innovative and reliable pharmaceutical products. In
April 2005, the company was formed through the merger of Fujisawa Pharmaceutical Co., Ltd. and Yamanouchi Pharmaceutical Co.,
Ltd. The organization is committed to becoming a global mega pharmaceutical company by combining outstanding R&D and
marketing capabilities and continuing to grow in the world pharmaceutical market.
The statements in this press release that are not historical facts are forward-looking statements based on current
expectations of future events that involve risks and uncertainties including, without limitation, risks associated with the
inherent uncertainty of the timing and success of pharmaceutical research, product development, manufacturing,
commercialization, economic conditions including interest and currency exchange rate fluctuations, changes in generally
accepted accounting principles, the impact of competitive or generic products, trade buying patterns, wars or terrorist acts,
product liability and other types of lawsuits, the impact of legislation and regulatory compliance and obtaining
reimbursement, favorable drug pricing, access and other approvals, environmental liabilities, and patent, and other risks and
uncertainties, including those detailed from time to time in the Company's periodic reports, including current reports on
Form 8-K, quarterly reports on Form 10-Q and the annual report on Form 10-K, filed with the Securities and Exchange
Commission. Actual results may vary materially from the forward-looking statements. The Company assumes no obligation to
publicly update any forward-looking statements, whether as a result of new information, future events or otherwise.
Media
Christopher Garland
Wyeth Pharmaceuticals
484-865-6323
Investor
Justin Victoria
Wyeth
973-660-5340
wyeth
воскресенье, 5 июня 2011 г.
Endocrine Society Calls For Medicare Coverage Of DXA Bone Density Testing To Be Extended To Men With Testosterone Deficiency
Hypogonadism, also known as testosterone deficiency, affects 4-5 million men in the United States placing them at risk for developing osteoporosis. Despite the clear association of testosterone deficiency with low bone density and osteoporosis, Medicare does not provide coverage for bone density testing for these individuals. To address this concern, today The Endocrine Society issued a Position Statement, endorsed by the National Osteoporosis Foundation, calling for Medicare coverage of bone density testing to be extended to this at-risk population.
Bone mineral density, measured by dual energy x-ray absorptiometry (DXA), is an excellent predictor of the risk of fractures in both men and women. Nationally, Medicare currently provides coverage for DXA scans in men only when an individual has been previously diagnosed with osteoporosis, osteopenia or has had a vertebral bone fracture. This means that most men found to have osteoporosis are diagnosed only after a hip or spine fracture has already occurred.
"The lack of Medicare coverage for DXA scans in men with hypogonadism results in underdiagnosis and undertreatment of osteoporosis, resulting in significant morbidity, mortality,and cost to society," said Robert Vigersky, MD, president of The Endocrine Society. "The Endocrine Society recommends widening the scope of Medicare coverage to include bone density scans for men with testosterone deficiency."
In the United States, 2 million osteoporotic fractures occur each year; 29 percent of these occur in men. Men also account for more than 80,000 hip fractures in the United States each year. In 2005, osteoporosis-related fractures in men were responsible for an estimated $4.3 billion in health care costs. By 2025, experts predict that these costs will rise to approximately
$6.3 billion.
There are a variety of conditions which cause hypogonadism, including tumors of the hypothalamus or pituitary gland, inflammatory or infectious diseases which affect the testes and even normal aging. Medications can also cause testosterone deficiency.
"The benefits of extending Medicare coverage of bone density testing in hypogonadal men should be more than enough incentive to change policy," said Vigersky. "Extended coverage can help prevent painful osteoporatic fractures and help reduce the high costs associated with those fractures. "
Source
The Endocrine Society
Bone mineral density, measured by dual energy x-ray absorptiometry (DXA), is an excellent predictor of the risk of fractures in both men and women. Nationally, Medicare currently provides coverage for DXA scans in men only when an individual has been previously diagnosed with osteoporosis, osteopenia or has had a vertebral bone fracture. This means that most men found to have osteoporosis are diagnosed only after a hip or spine fracture has already occurred.
"The lack of Medicare coverage for DXA scans in men with hypogonadism results in underdiagnosis and undertreatment of osteoporosis, resulting in significant morbidity, mortality,and cost to society," said Robert Vigersky, MD, president of The Endocrine Society. "The Endocrine Society recommends widening the scope of Medicare coverage to include bone density scans for men with testosterone deficiency."
In the United States, 2 million osteoporotic fractures occur each year; 29 percent of these occur in men. Men also account for more than 80,000 hip fractures in the United States each year. In 2005, osteoporosis-related fractures in men were responsible for an estimated $4.3 billion in health care costs. By 2025, experts predict that these costs will rise to approximately
$6.3 billion.
There are a variety of conditions which cause hypogonadism, including tumors of the hypothalamus or pituitary gland, inflammatory or infectious diseases which affect the testes and even normal aging. Medications can also cause testosterone deficiency.
"The benefits of extending Medicare coverage of bone density testing in hypogonadal men should be more than enough incentive to change policy," said Vigersky. "Extended coverage can help prevent painful osteoporatic fractures and help reduce the high costs associated with those fractures. "
Source
The Endocrine Society
суббота, 4 июня 2011 г.
FDA Broadens US Indication For Once-Yearly Reclast(R) As Only Osteoporosis Treatment Approved For Prevention Of Fractures After A Hip Fracture
The US Food and Drug
Administration (FDA) has broadened the US indication for once-yearly
Reclast(R) (zoledronic acid) Injection to include the prevention of new
clinical fractures in patients who have recently had a low-trauma hip
fracture(1).
No other osteoporosis treatment has demonstrated a reduction of new
clinical fractures in patients who have recently had a low-trauma hip
fracture (e.g., due to a fall from standing height or less)(1). A clinical
fracture is defined as a composite endpoint of skeletal sites excluding
finger, face and toe.
The FDA decision is based on safety and efficacy data from the landmark
Recurrent Fracture Trial, published in The New England Journal of Medicine,
showing a significant 35% reduction in the risk of new clinical fractures
in patients treated with Reclast(3).
"The consequences of osteoporosis can be devastating, particularly hip
fractures. However, few patients actually receive treatment for the
prevention of additional fractures after a hip fracture(2)," said Kenneth
G. Saag, MD, MSc, Professor of Medicine and Epidemiology, Division of
Clinical Immunology and Rheumatology, University of Alabama at Birmingham.
"In the first large scale clinical trial of its kind, these data support an
efficacious therapeutic option for patients after a hip fracture."
Osteoporosis is a condition in which the bones become weak and can
break more easily(4). Around 10 million people in the US are affected by
osteoporosis, which caused an estimated 297,000 hip fractures in the US in
2005(4). Of those patients who experience a hip fracture, almost a quarter
of people over the age of 50 die from complications within one year(4).
Among those who experience a hip fracture, 85% need help walking at six
months, nearly 20% who could walk before their hip fracture require
long-term nursing care, and all remain at high risk of further fracture(4).
Yet, currently few patients are treated for osteoporosis following a hip
fracture(2).
The Recurrent Fracture Trial involved more than 2,100 men and women
aged 50 and older with osteoporosis who had experienced a recent low-trauma
hip fracture(3). Results showed that Reclast increased bone mineral density
(BMD) and reduced the risk of new clinical fractures by 35% compared to
patients treated with placebo(3). The risk of new spine fractures was
reduced by 46%(3). The incidence of all-cause mortality was 9.6% in the
Reclast group and 13.3% in the placebo group(3).
The updated US label further reinforces the safety and efficacy of
Reclast, the only once-yearly treatment for postmenopausal osteoporosis
approved in the US and European Union (EU) (under the name Aclasta(R)) for
the reduction in the incidence of fractures in all key areas of the body
typically affected by this disease, including the hip, spine and
non-spine(1). Regulatory approval is also being sought for Aclasta in the
EU for this broadened indication.
Reclast is given as a once-yearly 15-minute intravenous infusion(1).
This means a single treatment, along with daily calcium and vitamin D
supplements, helps protect against fracture for a full year.
"The new label reinforces the potential of Reclast for treating a range
of osteoporosis patients," said Trevor Mundel, MD, Head of Global
Development Functions at Novartis Pharma AG. "These data support the clear
need to treat patients after hip fracture who are at risk of the
potentially devastating and life-threatening consequences of osteoporosis."
Reclast is already approved in more than 50 countries for the treatment
of postmenopausal osteoporosis and in more than 70 countries for the
treatment of Paget's disease of bone, the second most common metabolic bone
disorder(5).
The active ingredient in Reclast is zoledronic acid 5 mg administered
once a year(1). Zoledronic acid is also available in a different dosage
under the brand name Zometa(R) (zoledronic acid) Injection 4 mg
administered every three to four weeks in certain oncologic indications(6).
Patients should not take Reclast if they're on Zometa as it contains
the same ingredient; if they have low blood calcium, kidney problems, or
are allergic to Reclast or Zometa; or they're pregnant, plan to become
pregnant or nursing.
It's important for patients to drink fluids before getting Reclast to
help prevent kidney problems. The most common side effects are flu-like
symptoms, fever, muscle or joint pain and headache. Patients should tell
their doctor if they have dental problems because rarely, problems with the
jaw have been reported with Reclast. Patients should tell their doctor if
they have low blood calcium or cannot take calcium and vitamin D, had
surgery involving the neck or intestines. In patients with Paget's disease
of bone, it is especially important for them to take 1500 mg of calcium and
800 IU of vitamin D daily, particularly during the first 2 weeks after
getting Reclast. Patients should discuss all medicines they're taking,
including prescription and non-prescription, vitamins and herbal
supplements. Patients should contact their doctor if they develop severe
bone, joint or muscle pain, numbness, tingling or muscle spasms.
Disclaimer
The foregoing release contains forward-looking statements that can be
identified by terminology such as "option," "risk," "potential" or similar
expressions, or by express or implied discussions regarding potential new
indications or labelling for Reclast or regarding potential future revenues
from Reclast. Such forward-looking statements reflect the current views of
the Company regarding future events, and involve known and unknown risks,
uncertainties and other factors that may cause actual results with Reclast
to be materially different from any future results, performance or
achievements expressed or implied by such statements. There can be no
guarantee that Reclast will be approved for any additional indications or
labelling in any market. Nor can there be any guarantee that Reclast will
achieve any particular levels of revenue in the future. In particular,
management's expectations regarding Reclast could be affected by, among
other things, unexpected regulatory actions or delays or government
regulation generally; unexpected clinical trial results, including
unexpected new clinical data and unexpected additional analysis of existing
clinical data; unexpected regulatory actions or delays or government
regulation generally; the company's ability to obtain or maintain patent or
other proprietary intellectual property protection; competition in general;
government, industry and general public pricing pressures, and other risks
and factors referred to in Novartis AG's current Form 20-F on file with the
US Securities and Exchange Commission. Should one or more of these risks or
uncertainties materialize, or should underlying assumptions prove
incorrect, actual results may vary materially from those anticipated,
believed, estimated or expected. Novartis is providing the information in
this press release as of this date and does not undertake any obligation to
update any forward-looking statements contained in this press release as a
result of new information, future events or otherwise.
About Novartis
Novartis Pharmaceuticals Corporation researches, develops, manufactures
and markets leading innovative prescription drugs used to treat a number of
diseases and conditions, including those in the cardiovascular, metabolic,
cancer, organ transplantation, central nervous system, dermatological, GI
and respiratory areas. The company's mission is to improve people's lives
by pioneering novel healthcare solutions.
Located in East Hanover, New Jersey, Novartis Pharmaceuticals
Corporation is an affiliate of Novartis AG (NYSE: NVS), which provides
healthcare solutions that address the evolving needs of patients and
societies. Focused solely on growth areas in healthcare, Novartis offers a
diversified portfolio to best meet these needs: innovative medicines,
cost-saving generic pharmaceuticals, preventive vaccines and diagnostic
tools, and consumer health products. Novartis is the only company with
leading positions in these areas. In 2007, the Group's continuing
operations (excluding divestments in 2007) achieved net sales of USD 38.1
billion and net income of USD 6.5 billion. Approximately USD 6.4 billion
was invested in R&D activities throughout the Group. Headquartered in
Basel, Switzerland, Novartis Group companies employ approximately 98,200
full-time associates and operate in over 140 countries around the world.
For more information, please visit novartis.
References
1. Reclast(R) (zoledronic acid) Injection [Prescribing Information]. East
Hanover, NJ: Novartis Pharmaceuticals Corporation; June 2008
2. Cadarette SM, et al. Trends in drug prescribing for osteoporosis
after hip fracture, 1995-2004. Journal of Rheumatology. 2007;
35:319-326.
3. Lyles KW, Colon-Emeric CS, Magaziner JS, et al. for the HORIZON
Recurrent Fracture Trial. Zoledronic acid and clinical fractures and
mortality after hip fracture. N Engl J Med. 2007:537:1799-1809.
4. National Osteoporosis Foundation. Fast Facts on Osteoporosis Brochure.
February 2008.
5. U.S. Department of Health and Human Services. Bone Health and
Osteoporosis: A Report of the Surgeon General. 2004, p. 88.
6. Zometa(R) (zoledronic acid) Injection [Prescribing Information]. East
Hanover, NJ: Novartis Pharmaceuticals Corporation. March 2008.
Novartis
novartis
View drug information on Reclast; Zometa.
Administration (FDA) has broadened the US indication for once-yearly
Reclast(R) (zoledronic acid) Injection to include the prevention of new
clinical fractures in patients who have recently had a low-trauma hip
fracture(1).
No other osteoporosis treatment has demonstrated a reduction of new
clinical fractures in patients who have recently had a low-trauma hip
fracture (e.g., due to a fall from standing height or less)(1). A clinical
fracture is defined as a composite endpoint of skeletal sites excluding
finger, face and toe.
The FDA decision is based on safety and efficacy data from the landmark
Recurrent Fracture Trial, published in The New England Journal of Medicine,
showing a significant 35% reduction in the risk of new clinical fractures
in patients treated with Reclast(3).
"The consequences of osteoporosis can be devastating, particularly hip
fractures. However, few patients actually receive treatment for the
prevention of additional fractures after a hip fracture(2)," said Kenneth
G. Saag, MD, MSc, Professor of Medicine and Epidemiology, Division of
Clinical Immunology and Rheumatology, University of Alabama at Birmingham.
"In the first large scale clinical trial of its kind, these data support an
efficacious therapeutic option for patients after a hip fracture."
Osteoporosis is a condition in which the bones become weak and can
break more easily(4). Around 10 million people in the US are affected by
osteoporosis, which caused an estimated 297,000 hip fractures in the US in
2005(4). Of those patients who experience a hip fracture, almost a quarter
of people over the age of 50 die from complications within one year(4).
Among those who experience a hip fracture, 85% need help walking at six
months, nearly 20% who could walk before their hip fracture require
long-term nursing care, and all remain at high risk of further fracture(4).
Yet, currently few patients are treated for osteoporosis following a hip
fracture(2).
The Recurrent Fracture Trial involved more than 2,100 men and women
aged 50 and older with osteoporosis who had experienced a recent low-trauma
hip fracture(3). Results showed that Reclast increased bone mineral density
(BMD) and reduced the risk of new clinical fractures by 35% compared to
patients treated with placebo(3). The risk of new spine fractures was
reduced by 46%(3). The incidence of all-cause mortality was 9.6% in the
Reclast group and 13.3% in the placebo group(3).
The updated US label further reinforces the safety and efficacy of
Reclast, the only once-yearly treatment for postmenopausal osteoporosis
approved in the US and European Union (EU) (under the name Aclasta(R)) for
the reduction in the incidence of fractures in all key areas of the body
typically affected by this disease, including the hip, spine and
non-spine(1). Regulatory approval is also being sought for Aclasta in the
EU for this broadened indication.
Reclast is given as a once-yearly 15-minute intravenous infusion(1).
This means a single treatment, along with daily calcium and vitamin D
supplements, helps protect against fracture for a full year.
"The new label reinforces the potential of Reclast for treating a range
of osteoporosis patients," said Trevor Mundel, MD, Head of Global
Development Functions at Novartis Pharma AG. "These data support the clear
need to treat patients after hip fracture who are at risk of the
potentially devastating and life-threatening consequences of osteoporosis."
Reclast is already approved in more than 50 countries for the treatment
of postmenopausal osteoporosis and in more than 70 countries for the
treatment of Paget's disease of bone, the second most common metabolic bone
disorder(5).
The active ingredient in Reclast is zoledronic acid 5 mg administered
once a year(1). Zoledronic acid is also available in a different dosage
under the brand name Zometa(R) (zoledronic acid) Injection 4 mg
administered every three to four weeks in certain oncologic indications(6).
Patients should not take Reclast if they're on Zometa as it contains
the same ingredient; if they have low blood calcium, kidney problems, or
are allergic to Reclast or Zometa; or they're pregnant, plan to become
pregnant or nursing.
It's important for patients to drink fluids before getting Reclast to
help prevent kidney problems. The most common side effects are flu-like
symptoms, fever, muscle or joint pain and headache. Patients should tell
their doctor if they have dental problems because rarely, problems with the
jaw have been reported with Reclast. Patients should tell their doctor if
they have low blood calcium or cannot take calcium and vitamin D, had
surgery involving the neck or intestines. In patients with Paget's disease
of bone, it is especially important for them to take 1500 mg of calcium and
800 IU of vitamin D daily, particularly during the first 2 weeks after
getting Reclast. Patients should discuss all medicines they're taking,
including prescription and non-prescription, vitamins and herbal
supplements. Patients should contact their doctor if they develop severe
bone, joint or muscle pain, numbness, tingling or muscle spasms.
Disclaimer
The foregoing release contains forward-looking statements that can be
identified by terminology such as "option," "risk," "potential" or similar
expressions, or by express or implied discussions regarding potential new
indications or labelling for Reclast or regarding potential future revenues
from Reclast. Such forward-looking statements reflect the current views of
the Company regarding future events, and involve known and unknown risks,
uncertainties and other factors that may cause actual results with Reclast
to be materially different from any future results, performance or
achievements expressed or implied by such statements. There can be no
guarantee that Reclast will be approved for any additional indications or
labelling in any market. Nor can there be any guarantee that Reclast will
achieve any particular levels of revenue in the future. In particular,
management's expectations regarding Reclast could be affected by, among
other things, unexpected regulatory actions or delays or government
regulation generally; unexpected clinical trial results, including
unexpected new clinical data and unexpected additional analysis of existing
clinical data; unexpected regulatory actions or delays or government
regulation generally; the company's ability to obtain or maintain patent or
other proprietary intellectual property protection; competition in general;
government, industry and general public pricing pressures, and other risks
and factors referred to in Novartis AG's current Form 20-F on file with the
US Securities and Exchange Commission. Should one or more of these risks or
uncertainties materialize, or should underlying assumptions prove
incorrect, actual results may vary materially from those anticipated,
believed, estimated or expected. Novartis is providing the information in
this press release as of this date and does not undertake any obligation to
update any forward-looking statements contained in this press release as a
result of new information, future events or otherwise.
About Novartis
Novartis Pharmaceuticals Corporation researches, develops, manufactures
and markets leading innovative prescription drugs used to treat a number of
diseases and conditions, including those in the cardiovascular, metabolic,
cancer, organ transplantation, central nervous system, dermatological, GI
and respiratory areas. The company's mission is to improve people's lives
by pioneering novel healthcare solutions.
Located in East Hanover, New Jersey, Novartis Pharmaceuticals
Corporation is an affiliate of Novartis AG (NYSE: NVS), which provides
healthcare solutions that address the evolving needs of patients and
societies. Focused solely on growth areas in healthcare, Novartis offers a
diversified portfolio to best meet these needs: innovative medicines,
cost-saving generic pharmaceuticals, preventive vaccines and diagnostic
tools, and consumer health products. Novartis is the only company with
leading positions in these areas. In 2007, the Group's continuing
operations (excluding divestments in 2007) achieved net sales of USD 38.1
billion and net income of USD 6.5 billion. Approximately USD 6.4 billion
was invested in R&D activities throughout the Group. Headquartered in
Basel, Switzerland, Novartis Group companies employ approximately 98,200
full-time associates and operate in over 140 countries around the world.
For more information, please visit novartis.
References
1. Reclast(R) (zoledronic acid) Injection [Prescribing Information]. East
Hanover, NJ: Novartis Pharmaceuticals Corporation; June 2008
2. Cadarette SM, et al. Trends in drug prescribing for osteoporosis
after hip fracture, 1995-2004. Journal of Rheumatology. 2007;
35:319-326.
3. Lyles KW, Colon-Emeric CS, Magaziner JS, et al. for the HORIZON
Recurrent Fracture Trial. Zoledronic acid and clinical fractures and
mortality after hip fracture. N Engl J Med. 2007:537:1799-1809.
4. National Osteoporosis Foundation. Fast Facts on Osteoporosis Brochure.
February 2008.
5. U.S. Department of Health and Human Services. Bone Health and
Osteoporosis: A Report of the Surgeon General. 2004, p. 88.
6. Zometa(R) (zoledronic acid) Injection [Prescribing Information]. East
Hanover, NJ: Novartis Pharmaceuticals Corporation. March 2008.
Novartis
novartis
View drug information on Reclast; Zometa.
Improved Healing Of Bone Fractures After Radiation Exposure
A drug currently under development by the University of Pittsburgh School of Medicine may help bone fractures heal more quickly after radiation exposure, according to a study by Pitt researchers. The study's results were presented during the American Society for Radiation Oncology (ASTRO) annual meeting in Chicago.
The drug, JP4-039, is a free-radical scavenger targeted to the mitochondria, the energy generator of all cells. For this study, researchers compared the healing time of fractures in a mouse model system treated immediately after radiation exposure with JP4-039 against a control group of mice that did not receive the drug. The fractured bones in the group treated with JP4-039 healed much more rapidly than the control group.
"This study has important implications on two levels," said study author Abhay S. Gokhale, M.D., M.B.A., chief resident in the Department of Radiation Oncology. "From a patient care standpoint, this drug could eventually be beneficial to pediatric cancer patients who are vulnerable to the late effects of radiation treatment on bone growth and development. From an emergency response perspective, if the ideal dosage of the drug is developed and we find a way to have it easily administered, it could potentially help people exposed to radiation in an accident or attack."
The study, carried out in the laboratory of Joel Greenberger, M.D., and Michael Epperly, Ph.D., with co-investigator Peter Wipf, Ph.D., in the Department of Chemistry at Pitt, is overseen by Pitt's Center for Medical Countermeasures Against Radiation. The center is dedicated to identifying and developing small molecule radiation protectors and mitigators that can be easily accessed and administered in the event of a large-scale radiological or nuclear emergency.
Previous research conducted by this team showed that JP4-039 helps protect cells from the damaging effects of radiation.
This project has been funded in whole or in part with federal funds from the Biomedical Advanced Research and Development Authority, Office of the Assistant Secretary for Preparedness and Response, Office of the Secretary, Department of Health and Human Services, under Contract No. HHSO100200800062C.
Source: Courtney McCrimmon
University of Pittsburgh Schools of the Health Sciences
The drug, JP4-039, is a free-radical scavenger targeted to the mitochondria, the energy generator of all cells. For this study, researchers compared the healing time of fractures in a mouse model system treated immediately after radiation exposure with JP4-039 against a control group of mice that did not receive the drug. The fractured bones in the group treated with JP4-039 healed much more rapidly than the control group.
"This study has important implications on two levels," said study author Abhay S. Gokhale, M.D., M.B.A., chief resident in the Department of Radiation Oncology. "From a patient care standpoint, this drug could eventually be beneficial to pediatric cancer patients who are vulnerable to the late effects of radiation treatment on bone growth and development. From an emergency response perspective, if the ideal dosage of the drug is developed and we find a way to have it easily administered, it could potentially help people exposed to radiation in an accident or attack."
The study, carried out in the laboratory of Joel Greenberger, M.D., and Michael Epperly, Ph.D., with co-investigator Peter Wipf, Ph.D., in the Department of Chemistry at Pitt, is overseen by Pitt's Center for Medical Countermeasures Against Radiation. The center is dedicated to identifying and developing small molecule radiation protectors and mitigators that can be easily accessed and administered in the event of a large-scale radiological or nuclear emergency.
Previous research conducted by this team showed that JP4-039 helps protect cells from the damaging effects of radiation.
This project has been funded in whole or in part with federal funds from the Biomedical Advanced Research and Development Authority, Office of the Assistant Secretary for Preparedness and Response, Office of the Secretary, Department of Health and Human Services, under Contract No. HHSO100200800062C.
Source: Courtney McCrimmon
University of Pittsburgh Schools of the Health Sciences
пятница, 3 июня 2011 г.
What Are The Advantages Of Minimally Invasive Surgery For Hip Replacement?
With the evolution of new surgical methods, better anesthesia techniques, and computer navigation systems, surgeons are now able to reduce recovery times after hip replacement. The effects of such methods and technologies allow the surgeon to operate with greater precision and less injury to the body. Minimally Invasive Surgery for Joint Replacement (MIS) is one surgical approach with this goal in mind.
The term, however, can be misleading. In a broad sense, minimally invasive surgery for hip replacement refers to a surgical method that uses a smaller incision. Many surgeons have this goal in mind already, and incorporate it into the existing techniques for a traditional hip replacement. An article put out by the University of Missouri-Columbia School of Medicine reads:
"Minimally invasive surgery variations of both the posterior approach and the lateral approach are popular today, and these involve re-training surgeons to learn how to do the same approach using a smaller skin opening. Most surgeons refer to an incision that is 4 inches or less in length as 'minimally invasive.'"
But there are new surgical methods, also called minimally invasive, which go beyond making the smaller incision. These new surgical methods avoid cutting into the muscle altogether, which distinguishes them from traditional methods. Fewer surgeons are trained in these methods and special instruments and implants are required. One example is the MIS-2 incision hip replacement. The same article put out by the University of Missouri-Columbia School of Medicine describes the difference between a surgical method that makes a smaller incision and the MIS-2:
"What is new is the adaptation of this previously described pathway of reaching the hip joint to a new method of performing hip replacement surgery using two incisions that are very small. More important than the incision size or number is the fact that under the skin, the muscles are spread in their natural planes. The surgeon navigates a path around the muscles, without cutting into them."
The advantage of any minimally invasive surgery is less injury to the body. With more radical approaches, such as MIS-2 incision, there is reduced trauma to the deep muscle tissues and underlying structure of the hip. Because of the reduced trauma, patients feel better and recover faster. However, always remember that the size of the incision will be dictated by the size of the implants and the need to be able to manipulate them inside the joint to get the optimal positioning. Getting accurate positioning is key to the success of the entire procedure. The physicians at the University of Missouri-Columbia School of Medicine write:
"With modern hip replacement surgeries, the person is encouraged to become mobile much earlier than with standard methods of hip replacements. Many people are able to get out of bed either the same day or the next day, with the help of a physical therapist. In many cases outpatient therapy is not necessary, although it can help certain patients."
This should not give the reader the impression that minimally invasive surgical techniques are free of risks and complications. Blood-clots, for example, still occur and surgeons must apply methods to reduce them. In addition, most surgeons will still restrict the patient for six weeks after the surgery.
Keep in mind that all surgery is invasive to the body. These new surgical techniques merely reduce injury and trauma. If you believe you may be a candidate for minimally invasive hip replacement surgery, do research, talks with doctors, and always weigh the short-term benefits and the long-term results.
About Author
Jeremy Reither manages the online outreach effort for BoneSmart®, which is dedicated to raising global awareness about knee replacement and hip replacement options for consumers. He specializes in raising consumer awareness through the use of new media and internet technologies.
Source
Bonesmart
The term, however, can be misleading. In a broad sense, minimally invasive surgery for hip replacement refers to a surgical method that uses a smaller incision. Many surgeons have this goal in mind already, and incorporate it into the existing techniques for a traditional hip replacement. An article put out by the University of Missouri-Columbia School of Medicine reads:
"Minimally invasive surgery variations of both the posterior approach and the lateral approach are popular today, and these involve re-training surgeons to learn how to do the same approach using a smaller skin opening. Most surgeons refer to an incision that is 4 inches or less in length as 'minimally invasive.'"
But there are new surgical methods, also called minimally invasive, which go beyond making the smaller incision. These new surgical methods avoid cutting into the muscle altogether, which distinguishes them from traditional methods. Fewer surgeons are trained in these methods and special instruments and implants are required. One example is the MIS-2 incision hip replacement. The same article put out by the University of Missouri-Columbia School of Medicine describes the difference between a surgical method that makes a smaller incision and the MIS-2:
"What is new is the adaptation of this previously described pathway of reaching the hip joint to a new method of performing hip replacement surgery using two incisions that are very small. More important than the incision size or number is the fact that under the skin, the muscles are spread in their natural planes. The surgeon navigates a path around the muscles, without cutting into them."
The advantage of any minimally invasive surgery is less injury to the body. With more radical approaches, such as MIS-2 incision, there is reduced trauma to the deep muscle tissues and underlying structure of the hip. Because of the reduced trauma, patients feel better and recover faster. However, always remember that the size of the incision will be dictated by the size of the implants and the need to be able to manipulate them inside the joint to get the optimal positioning. Getting accurate positioning is key to the success of the entire procedure. The physicians at the University of Missouri-Columbia School of Medicine write:
"With modern hip replacement surgeries, the person is encouraged to become mobile much earlier than with standard methods of hip replacements. Many people are able to get out of bed either the same day or the next day, with the help of a physical therapist. In many cases outpatient therapy is not necessary, although it can help certain patients."
This should not give the reader the impression that minimally invasive surgical techniques are free of risks and complications. Blood-clots, for example, still occur and surgeons must apply methods to reduce them. In addition, most surgeons will still restrict the patient for six weeks after the surgery.
Keep in mind that all surgery is invasive to the body. These new surgical techniques merely reduce injury and trauma. If you believe you may be a candidate for minimally invasive hip replacement surgery, do research, talks with doctors, and always weigh the short-term benefits and the long-term results.
About Author
Jeremy Reither manages the online outreach effort for BoneSmart®, which is dedicated to raising global awareness about knee replacement and hip replacement options for consumers. He specializes in raising consumer awareness through the use of new media and internet technologies.
Source
Bonesmart
четверг, 2 июня 2011 г.
Innovations Make Hip Replacement Safe, Less Invasive
According to the Centers for Disease Control and Prevention (CDC), hip replacements are among the most common surgical procedures in the United States; and with osteoarthritis and obesity on the rise, demand for the procedure is expected to grow.
From 1996 to 2006, the number of hip replacement surgeries performed nationally increased by 30 percent, partial hip replacements increased by 60 percent; and the number of the surgeries performed on those aged 65 years and older is more than three times that of their younger counterparts (source: CDC). At NewYork-Presbyterian Hospital/Columbia University Medical Center, the number of hip replacements has increased two-fold since 1999.
"When it hurts to get around in daily life or you can't participate in your favorite sports or hobbies and your medication and physical therapy aren't working anymore, it's time to talk to your doctor. Hip replacement surgery may be right for you," says Dr. Jeffrey A. Geller, director of minimally invasive joint replacement surgery at the Center for Hip and Knee Replacement at NewYork-Presbyterian Hospital/Columbia University Medical Center and assistant professor of orthopedic surgery at Columbia University College of Physicians and Surgeons. "After a hip replacement, most patients are in the hospital for two or three days and can get around with a walker about a week later. From there, they transition to a cane, and often return to walking on their own within two to three weeks."
Surgical Innovations
Hip replacement has seen significant advances in minimally invasive surgical techniques. For one surgical option, Dr. Geller and his colleagues use a method that reduces trauma and leads to a much quicker recovery. Traditional approaches require surgeons to split and detach large portions of the musculature; however, Dr. Geller is able to use a small front or rear incision in some cases.
Dr. Geller and his colleagues are also using robotics to improve outcomes in orthopedic surgery. "In the near future, robotic surgery may give us improved accuracy when placing the hip socket, which if it isn't in the correct position could lead to dislocation or the artificial joint wearing out earlier than it should," says Dr. Geller.
Another improvement has been seen with the replacement joints themselves. The first generation of joints had a shelf-life of about 15 years. "Today patients can get as many as 20 years out of their new hips, and with the newest generation of implants, replacement hips may last as long as 30 years," adds Dr. Geller.
Research Update
Dr. Jeffrey A. Geller and his colleagues recently published a study in the Journal of Bone and Joint Surgery addressing a rare complication of hip replacement. Even with a successful initial surgery, it is possible for patients to experience pain and weakness if the gluteus medius muscle -- one of the main supporting muscles of the hip -- is damaged or underperforming. Traditionally there was no satisfactory way to repair the muscle, as any grafts or sutures proved too weak to withstand the force exerted on the muscle.
The new research reports on an innovative surgical approach that reinforces the muscle graft with a piece of the Achilles tendon. "From 2003 to 2006, seven patients received the novel treatment at NewYork-Presbyterian Hospital/Columbia and the results have been very encouraging with all patients experiencing greater strength and decreased or even absent pain," says Dr. Geller.
Source: NewYork-Presbyterian Hospital
From 1996 to 2006, the number of hip replacement surgeries performed nationally increased by 30 percent, partial hip replacements increased by 60 percent; and the number of the surgeries performed on those aged 65 years and older is more than three times that of their younger counterparts (source: CDC). At NewYork-Presbyterian Hospital/Columbia University Medical Center, the number of hip replacements has increased two-fold since 1999.
"When it hurts to get around in daily life or you can't participate in your favorite sports or hobbies and your medication and physical therapy aren't working anymore, it's time to talk to your doctor. Hip replacement surgery may be right for you," says Dr. Jeffrey A. Geller, director of minimally invasive joint replacement surgery at the Center for Hip and Knee Replacement at NewYork-Presbyterian Hospital/Columbia University Medical Center and assistant professor of orthopedic surgery at Columbia University College of Physicians and Surgeons. "After a hip replacement, most patients are in the hospital for two or three days and can get around with a walker about a week later. From there, they transition to a cane, and often return to walking on their own within two to three weeks."
Surgical Innovations
Hip replacement has seen significant advances in minimally invasive surgical techniques. For one surgical option, Dr. Geller and his colleagues use a method that reduces trauma and leads to a much quicker recovery. Traditional approaches require surgeons to split and detach large portions of the musculature; however, Dr. Geller is able to use a small front or rear incision in some cases.
Dr. Geller and his colleagues are also using robotics to improve outcomes in orthopedic surgery. "In the near future, robotic surgery may give us improved accuracy when placing the hip socket, which if it isn't in the correct position could lead to dislocation or the artificial joint wearing out earlier than it should," says Dr. Geller.
Another improvement has been seen with the replacement joints themselves. The first generation of joints had a shelf-life of about 15 years. "Today patients can get as many as 20 years out of their new hips, and with the newest generation of implants, replacement hips may last as long as 30 years," adds Dr. Geller.
Research Update
Dr. Jeffrey A. Geller and his colleagues recently published a study in the Journal of Bone and Joint Surgery addressing a rare complication of hip replacement. Even with a successful initial surgery, it is possible for patients to experience pain and weakness if the gluteus medius muscle -- one of the main supporting muscles of the hip -- is damaged or underperforming. Traditionally there was no satisfactory way to repair the muscle, as any grafts or sutures proved too weak to withstand the force exerted on the muscle.
The new research reports on an innovative surgical approach that reinforces the muscle graft with a piece of the Achilles tendon. "From 2003 to 2006, seven patients received the novel treatment at NewYork-Presbyterian Hospital/Columbia and the results have been very encouraging with all patients experiencing greater strength and decreased or even absent pain," says Dr. Geller.
Source: NewYork-Presbyterian Hospital
среда, 1 июня 2011 г.
Biogen Idec Announces Top-Line Results From Phase II Clinical Trial Of Baminercept In Rheumatoid Arthritis
Biogen Idec (NASDAQ: BIIB) announced today that its Phase II trial of baminercept (BG9924, LTBR-Ig) in rheumatoid arthritis (RA) patients who have had an inadequate response to conventional therapy with a disease-modifying antirheumatic drug (DMARD) did not meet its primary endpoint. The primary endpoint was defined as the proportion of baminercept-treated patients who achieved an ACR50 response, a standard measure of disease improvement in RA, compared to placebo at 14 weeks. The study also did not meet any of the pre-specified secondary endpoints. Biogen Idec will continue to analyze the study results and will submit the data for presentation at an upcoming medical meeting.
Based on these results as well as preliminary data from a Phase II trial of baminercept in RA patients who have had an inadequate response to a tumor necrosis factor (TNF) inhibitor, the company has decided to discontinue the development of the compound in RA.
About the 104RA202 Study
The 104RA202 study was a Phase II randomized, double-blind, placebo-controlled, multicenter, dose-finding trial involved 380 individuals with active RA who had an inadequate response to conventional DMARD therapy. The trial was designed to assess the efficacy of five different regimens of baminercept when administered over 12 weeks in combination with methotrexate within this patient population.
About the 104RA203 Study
The 104RA203 study was a Phase II randomized, double-blind, placebo-controlled, multicenter trial in patients with active RA who had an inadequate response to TNF inhibitors. About 120 patients were expected to be enrolled in the trial, which was designed to assess the efficacy of 200 mg dose of baminercept administered over 12 weeks in combination with methotrexate.
In both studies, the primary endpoint was the proportion of patients who achieved an ACR50 response, defined as a 50% improvement compared to baseline for swollen and tender joint counts and other clinical measures, at week 14. Secondary endpoints included the proportion of patients to achieve scores of ACR20 (a 20% improvement compared to baseline for swollen and tender joint counts and other clinical measures) and ACR70 (a 70% improvement compared to baseline for swollen and tender joint counts and other clinical measures), improvement in DAS scores, and accepted tools to evaluate improvements in Quality of Life.
The safety data to date, including incidence of overall adverse events, serious adverse events and infections, suggest that baminercept was well-tolerated.
About RA
RA is a debilitating autoimmune disease that affects an estimated 1.3 million Americans and hinders daily activities. The damage that occurs in RA is a result of the immune system attacking joint tissue, causing painful chronic inflammation, irreversible destruction of cartilage, tendons and bones, which often results in disability. Common RA symptoms include inflammation of the joints, swelling, fatigue, stiffness and pain. Additionally, since RA is a systemic disease, it can affect other tissues such as the lungs and eyes.
About Biogen Idec
Biogen Idec creates new standards of care in therapeutic areas with high unmet medical needs. Founded in 1978, Biogen Idec is a global leader in the discovery, development, manufacturing, and commercialization of innovative therapies. Patients in more than 90 countries benefit from Biogen Idec's significant products that address diseases such as lymphoma, multiple sclerosis, and rheumatoid arthritis. For product labeling, press releases and additional information about the company, please visit biogenidec.
Safe Harbor/Forward-Looking Statements
This press release contains "forward-looking statements" regarding Biogen Idec's development of baminercept and therapies for autoimmune diseases that are based on current expectations and assumptions that are subject to risks and uncertainties. Only a small number of research and development programs result in commercialization of a product. In addition, the company may not be able to meet applicable regulatory standards or regulatory authorities may fail to approve the therapies that we develop; and the company may encounter other unexpected hurdles. For further information regarding factors, risks and uncertainties relating to Biogen Idec's drug research and development and other activities, please refer to the filings Biogen Idec has made with the Securities and Exchange Commission, including the "Risk Factors" section of Biogen Idec's Quarterly and Annual Reports, copies of which may be obtained at biogenidec. Biogen Idec assumes no obligation to update and specifically disclaims any duty to update the information in this press release for any reason, except as required by law, even as new information becomes available or other events occur in the future. All forward-looking statements in this press release are qualified in their entirety by this cautionary statement.
Biogen Idec
Based on these results as well as preliminary data from a Phase II trial of baminercept in RA patients who have had an inadequate response to a tumor necrosis factor (TNF) inhibitor, the company has decided to discontinue the development of the compound in RA.
About the 104RA202 Study
The 104RA202 study was a Phase II randomized, double-blind, placebo-controlled, multicenter, dose-finding trial involved 380 individuals with active RA who had an inadequate response to conventional DMARD therapy. The trial was designed to assess the efficacy of five different regimens of baminercept when administered over 12 weeks in combination with methotrexate within this patient population.
About the 104RA203 Study
The 104RA203 study was a Phase II randomized, double-blind, placebo-controlled, multicenter trial in patients with active RA who had an inadequate response to TNF inhibitors. About 120 patients were expected to be enrolled in the trial, which was designed to assess the efficacy of 200 mg dose of baminercept administered over 12 weeks in combination with methotrexate.
In both studies, the primary endpoint was the proportion of patients who achieved an ACR50 response, defined as a 50% improvement compared to baseline for swollen and tender joint counts and other clinical measures, at week 14. Secondary endpoints included the proportion of patients to achieve scores of ACR20 (a 20% improvement compared to baseline for swollen and tender joint counts and other clinical measures) and ACR70 (a 70% improvement compared to baseline for swollen and tender joint counts and other clinical measures), improvement in DAS scores, and accepted tools to evaluate improvements in Quality of Life.
The safety data to date, including incidence of overall adverse events, serious adverse events and infections, suggest that baminercept was well-tolerated.
About RA
RA is a debilitating autoimmune disease that affects an estimated 1.3 million Americans and hinders daily activities. The damage that occurs in RA is a result of the immune system attacking joint tissue, causing painful chronic inflammation, irreversible destruction of cartilage, tendons and bones, which often results in disability. Common RA symptoms include inflammation of the joints, swelling, fatigue, stiffness and pain. Additionally, since RA is a systemic disease, it can affect other tissues such as the lungs and eyes.
About Biogen Idec
Biogen Idec creates new standards of care in therapeutic areas with high unmet medical needs. Founded in 1978, Biogen Idec is a global leader in the discovery, development, manufacturing, and commercialization of innovative therapies. Patients in more than 90 countries benefit from Biogen Idec's significant products that address diseases such as lymphoma, multiple sclerosis, and rheumatoid arthritis. For product labeling, press releases and additional information about the company, please visit biogenidec.
Safe Harbor/Forward-Looking Statements
This press release contains "forward-looking statements" regarding Biogen Idec's development of baminercept and therapies for autoimmune diseases that are based on current expectations and assumptions that are subject to risks and uncertainties. Only a small number of research and development programs result in commercialization of a product. In addition, the company may not be able to meet applicable regulatory standards or regulatory authorities may fail to approve the therapies that we develop; and the company may encounter other unexpected hurdles. For further information regarding factors, risks and uncertainties relating to Biogen Idec's drug research and development and other activities, please refer to the filings Biogen Idec has made with the Securities and Exchange Commission, including the "Risk Factors" section of Biogen Idec's Quarterly and Annual Reports, copies of which may be obtained at biogenidec. Biogen Idec assumes no obligation to update and specifically disclaims any duty to update the information in this press release for any reason, except as required by law, even as new information becomes available or other events occur in the future. All forward-looking statements in this press release are qualified in their entirety by this cautionary statement.
Biogen Idec
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