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

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