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Tarsa Therapeutics Completes Phase III Trial of its Oral Calcitonin for Treatment of Postmenopausal Osteoporosis and Initiates Phase II Trial in Osteoporosis Prevention
Date:2/14/2011

PHILADELPHIA, Feb. 14, 2011 /PRNewswire/ -- Tarsa Therapeutics, Inc. today announced completion of its global Phase III ORACAL trial testing the company's once-daily oral recombinant calcitonin for the treatment of postmenopausal osteoporosis.  Results from the ORACAL trial are expected in early spring.  In addition, Tarsa announced initiation of a new Phase II study of its oral calcitonin for the prevention of postmenopausal osteoporosis.  

The ORACAL study is a multinational, randomized, double-blind, active and placebo-controlled Phase III trial that enrolled 565 postmenopausal women with osteoporosis.  Analysis of the trial data is currently underway.  

The new Phase II prevention trial is a randomized, double-blind, placebo-controlled study designed to enroll approximately 120 postmenopausal women with low bone mass at increased risk of fracture.  The trial will assess the efficacy of Tarsa's oral calcitonin in the prevention of bone loss in these women, as well as its safety and tolerability.  The prevention trial is being conducted at multiple centers in the US.

"The conclusion of our Phase III ORACAL osteoporosis treatment trial and initiation of our Phase II prevention trial are major milestones in Tarsa's oral calcitonin program," said David Brand, President and CEO of Tarsa.  "Our tablet has the potential to offer calcitonin's 30-year record of safety and efficacy with the advantage of once-daily oral administration to the millions of postmenopausal women with osteoporosis or at risk of osteoporosis.  We look forward to releasing ORACAL safety and efficacy data in the coming months.  If positive, we believe that our product has the potential to be the first FDA-approved oral formulation of calcitonin to reach the market."  

Tarsa plans to submit a New Drug Application to the US Food and Drug Administration for the use of its oral calcitonin as a treatment for postmenopau
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SOURCE Tarsa Therapeutics, Inc.
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