Tarsa Therapeutics, Inc. and Unigene Laboratories, Inc. (OTC Bulletin Board: UGNE) reported preclinical data showing that calcitonin may have synergistic effects in combination with other drugs in reducing the collagen degradation associated with osteoarthritis. The data are being presented at the 2010 Osteoarthritis Research Society International (OARSI) World Congress in Brussels, Belgium. Unigene produces Fortical® nasal calcitonin product for the treatment of postmenopausal osteoporosis and Tarsa's oral calcitonin, which is licensed from Unigene, is in a Phase III trial for the treatment of osteoporosis.
The study was designed to identify whether the combination of salmon calcitonin and other recognized and experimental anti-arthritis drugs can produce additive or synergistic effects in reducing collagen degradation in a bovine in vitro collagen matrix model. The results were reported by Dr. James P. Gilligan, Chief Scientific Officer of Tarsa, and Dr. Nozer Mehta, Vice President, Biological Research and Development at Unigene.
Dr. Gilligan commented, "The impetus for this study is the fact that osteoarthritis is a complex, multi-modal disease, so combination therapy may be the most effective approach to treatment. We hypothesized that a potentially disease-modifying osteoarthritis drug such as calcitonin given in combination with other anti-arthritic agents might result in additive or synergistic effects."
In the data presented, calcitonin did exhibit synergistic effects in reducing collagen degradation when combined with low doses of each of two other experimental anti-arthritis agents, while none of the agents reduced collagen release on its own at the concentrations used.
Dr. Mehta noted, "While preliminary, these data lend support to the concept that calcitonin may have a role in reducing cartilage degradation and bone loss as part of a combination therapy for treating osteoarthritis. In addition, in our studies the synergistic effects were achieved using low doses of the compounds. This type of combination therapy may have the potential to treat osteoarthritis more effectively while reducing the safety concerns associated with higher doses of existing anti-arthritis agents."
The annual OARSI Congress is a global forum for all people interested and involved in osteoarthritis research and treatment: basic scientists from academia and industry, clinical investigators, physicians (radiologists, rheumatologists, orthopaedic surgeons, etc.), allied health professionals and policy makers. It is being held in Brussels, Belgium September 23-26, 2010.
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.
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Source: Tarsa Therapeutics, Inc