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Tarsa Therapeutics Presents Positive Efficacy and Safety Data Comparing Its Oral Calcitonin to Nasal Calcitonin and Placebo in Phase III Osteoporosis Treatment Trial
Date:9/19/2011

SAN DIEGO, and PHILADELPHIA, Sept. 19, 2011 /PRNewswire/ -- Tarsa Therapeutics today reported that it presented positive safety and efficacy data from its Phase III ORACAL trial of OSTORA™, the company's oral recombinant salmon calcitonin tablet in development for the treatment of postmenopausal osteoporosis.  These data were presented at the American Society for Bone and Mineral Research 2011 Annual Meeting by ORACAL investigator Neil Binkley, MD, who is an Associate Professor of Endocrinology and Geriatrics at the University of Wisconsin School of Medicine and Public Health in Madison, Wisconsin.

The ORACAL study was a Phase III multinational, randomized, double-blind, double-dummy, placebo controlled trial of Tarsa's oral recombinant salmon calcitonin compared to placebo and to commercially available, synthetic salmon calcitonin administered by nasal spray.  The trial enrolled 565 postmenopausal women in six countries with established osteoporosis.

Earlier this year, Tarsa reported top-line efficacy and safety results from the ORACAL trial.  The data reported today show that OSTORA achieved all of the efficacy endpoints in the trial and indicate that the safety profile of OSTORA did not substantially differ from nasal calcitonin or placebo.  The majority of adverse events were mild or moderate, and OSTORA was also significantly less immunogenic than nasal calcitonin spray.  

"These are encouraging results that may be of particular relevance for the women with osteoporosis who are reluctant to take or unable to tolerate currently available treatments," said Dr. Binkley.  "Potential safety issues with current drug therapies, while rare, have led some osteoporosis patients to discontinue therapy or avoid beginning treatment.  Calcitonin has a long history of safety for postmenopausal osteoporosis treatment, and potential availability of this once-daily oral formulation could make it a useful new option
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SOURCE Tarsa Therapeutics
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