BASEL (dpa-AFX) - Emisphere Technologies, Inc. (EMIS.OB) Thursday said Novartis Pharma AG (NVS) informed it of results of Phase III Study 2302 assessing the safety and efficacy of oral calcitonin or oCT in the treatment of osteoarthritis of the knee. The study incorporates Emisphere's proprietary Eligen Drug Delivery Technology for the improved oral absorption of salmon calcitonin.
Following completion of Study 2302, Novartis recently informed Emisphere that it has reviewed the first interpretable results. Preliminary analysis of two year study data showed both co-primary endpoints and secondary endpoints of the study were not met. Additionally, preliminary analysis of Study 2302 data showed a positive safety profile.
In July 2010, Novartis had informed Emisphere that an independent Data Monitoring Committee or DMC conducted a futility analysis of one-year data for all patients enrolled in Study 2302, including assessments of safety and efficacy parameters. Although the DMC concluded that there was no reason to stop Study 2302 because of safety concerns, it had determined that there was no reason to continue the study for efficacy.
Novartis' license partner Nordic Bioscience recently presented the results from the two year Phase III Study 2301, the companion study to Study 2302, at the Osteoarthritis Research Society International or OARSI World Congress on Osteoarthritis held September 15 -- 18, 2011, in San Diego. Although improvement on the primary endpoint of JSW (joint-space width) was not reached, there was an increase in cartilage volume vs. placebo indicating some structure-modifying efficacy.
Novartis and Nordic Bioscience had decided to continue the 2301 study to be able to pool results and compare safety information, based on a previously more encouraging futility analysis of the Study.
Cedar Knolls, New Jersey-based Emisphere said Novartis has not provided any further data from either Study 2302 or Study 2301 at this time. Emisphere said Nordic Bioscience and Novartis have indicated that they are going to continue to work together to further analyze and evaluate the results. Additionally, a Phase III study of oral calcitonin in osteoporosis has been completed and first interpretable results are expected in the fourth quarter of 2011.
Calcitonin (salmon) is a hypocalcemic hormone produced by the parafollicular C cells of the thyroid or by the ultimobranchial bodies of nonmammalian vertebrates.
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