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Tarsa Therapeutics Reports Positive Top-Line Results From Pivotal Phase III ORACAL Trial of its Oral Calcitonin in Treatment of Postmenopausal Osteoporosis
Date:3/24/2011

nd efficacy of calcitonin with the advantage of once-daily oral administration to the millions of postmenopausal women with osteoporosis.  We believe that our product has the potential to be the first FDA-approved oral formulation of calcitonin to reach the market."  

Separately, Tarsa announced that it has completed screening and has begun to randomize patients in its Phase II osteoporosis prevention trial.  TAR01-201 is a double-blind study comparing Tarsa's oral recombinant salmon calcitonin to placebo in approximately 120 postmenopausal women who have low bone mass (osteopenia) and are at increased risk of fracture.  This proof-of-concept study is evaluating the ability of oral calcitonin to prevent osteoporosis and maintain bone mass in this population.  This trial, conducted entirely in the US, is expected to complete enrollment by the end of April 2011.

Dr. David Krause, Chief Medical Officer of Tarsa, commented, "Calcitonin has a long history of safety and efficacy as an osteoporosis therapy, and we believe that the availability of Tarsa's easy-to-use, once-daily oral calcitonin tablet would be welcomed by many healthcare providers and patients who are seeking additional osteoporosis treatment and prevention options, especially in view of continuing concerns about potential long-term safety issues with some other popular classes of osteoporosis drugs."

Calcitonin is approved for the treatment and prevention of postmenopausal osteoporosis, but its use has been limited by the fact that it is currently available only in intranasal and injectable forms.  Tarsa's oral calcitonin product has been shown in prior clinical studies to deliver the desired blood levels of calcitonin and reduce levels of biomarkers of bone resorption.  

For more information about the ORACAL osteoporosis treatment trial and the TAR01-201 osteoporosis prevention trial, visit

SOURCE Tarsa Therapeutics, Inc.
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