Tarsa Therapeutics Advances Phase III ORACAL Trial Of Its Oral Calcitonin For The Treatment Of Postmenopausal Osteoporosis

Main Category: Bones / Orthopedics
Also Included In: Women's Health / Gynecology;  Clinical Trials / Drug Trials
Article Date: 23 Jul 2010 - 2:00 PDT

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Tarsa Therapeutics, Inc. announced progress in the ORACAL trial of its oral calcitonin product for the treatment of postmenopausal osteoporosis. The company has completed patient enrollment in this multinational, randomized, double-blind, placebo-controlled Phase III trial designed to enroll approximately 550 patients. In addition, Tarsa announced that the independent Data Monitoring Committee (DMC) for the ORACAL trial has completed two separate safety reviews of patient data and recommended that the trial proceed as planned.

David Brand, President and CEO of Tarsa noted, "These are promising developments as we advance our once-daily oral calcitonin tablet that has the potential to offer patients the proven safety and efficacy of calcitonin with the significant advantage of easier administration and the potential for enhanced long-term compliance. We are delighted that enrollment in the ORACAL trial has proceeded so well and that the DMC has confirmed that there are no safety issues that prevent us from continuing the trial as planned. We look forward to reporting data from the complete Phase III study next year."

Calcitonin is approved for the treatment of postmenopausal women with 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 bone resorption biomarkers. It has the potential to offer a new therapeutic option for osteoporosis patients as the first FDA-approved and commercially available oral formulation of calcitonin.

Dr. David Krause, Chief Medical Officer of Tarsa, commented, "We are hearing considerable interest from health professionals who would like access to the treatment option of an osteoporosis product that offers calcitonin's record of safety and efficacy along with the ease-of-use of an oral product, thereby enhancing patient acceptance and compliance. In addition, continuing concerns about potential long-term safety issues with other popular classes of osteoporosis drugs highlight the need for additional choices for osteoporosis patients and their healthcare providers."

About Tarsa Therapeutics

Tarsa Therapeutics is developing an oral formulation of calcitonin for the treatment of osteoporosis. Calcitonin is a peptide hormone that inhibits bone resorption, the underlying process that can result in osteoporosis. Availability of an oral formulation is expected to generate wider use of this established osteoporosis treatment, which currently is available only in injectable and intranasal formulations. Tarsa's oral calcitonin has generated promising data in Phase II studies and the ORACAL study, a global Phase III clinical trial, has completed patient enrollment.

Source: Tarsa Therapeutics, Inc

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