>>NPS Announces Progression of the Calcilytics Development Program in Osteoporosis by GlaxoSmithKline
Monday June 4, 4:39 pm ET
PARSIPPANY, N.J., June 4 /PRNewswire-FirstCall/ -- NPS Pharmaceuticals, Inc. (Nasdaq: NPSP - News) today announced that GlaxoSmithKline (GSK), under a collaboration agreement between the two companies, has dosed the first patient in a Phase II dose-range finding study with the investigational calcilytic compound 751689 in post-menopausal women with osteoporosis.
The Phase II, double blind, placebo-controlled study will evaluate the efficacy and safety of compound 751689 over a twelve month period. The study will enroll approximately 520 post-menopausal women with osteoporosis and is designed to assess the overall efficacy, safety, and tolerability of 751689 in comparison with placebo and two active comparators. Outcome measures include bone mineral density of the lumbar spine and hip, vertebral and hip strength parameters, and biomarkers of bone turnover. Data from this study, along with other data, will be used to select a dose of compound 751689 for further evaluation.
NPS CEO and president, Tony Coles, M.D., stated, "We are pleased that the development of the calcilytics program is advancing under GSK's leadership. We believe that calcilytics have the potential to represent an important new class of drugs for the treatment of osteoporosis and look forward to the results of this exciting trial."
Under the terms of the Collaborative Research and License Agreement with GSK, NPS will receive royalties on global product sales and has the option to co-promote products resulting from the collaboration with GSK in the United States.
ABOUT CALCILYTICS
Calcilytics are novel small molecules that work by antagonizing calcium-sensing receptors on the surface of the parathyroid gland, thereby triggering a transient release of the body's own stores of parathyroid hormone (PTH). This release of PTH may have the potential to rebuild the bone mass lost as a result of osteoporosis and improve overall bone microarchitecture in these patients. NPS and GSK have previously disclosed that in animal models, daily oral administration of a calcilytic compound was shown to stimulate new bone formation, increase bone mineral density (BMD) at vertebral and non-vertebral skeletal sites, and increase biomechanical parameters of bone strength.<<
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Well, finally, some clinical progress. Though results probably won't be known until about ~09. Guessing Glaxo won't do an interim look, but perhaps the company will soon say something about that.
Cheers, Tuck |
