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news.Emisphere Technologies (Emisphere), has stated that Novartis Pharma and its license partner Nordic Bioscience have updated on their Phase III study 2302 in osteoarthritis, assessing the safety and efficacy of oral Calcitonin in the treatment of osteoarthritis of the knee, which incorporates Emisphere's Eligen drug delivery technology for the improved oral absorption of salmon Calcitonin.
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Emisphere said that an independent Data Monitoring Committee (DMC) conducted a futility analysis of one-year data for all patients enrolled in this two-year study, including assessments of safety and efficacy parameters.
Reportedly, DMC concluded that although there is no reason to stop study 2302 because of safety concerns, there is no reason to continue the study for efficacy. The DMC also concluded that the final decision whether to continue study 2302 rests with Nordic Bioscience.
Emisphere stated that a parallel two-year Phase III study 2301 in osteoarthritis assessing the safety and efficacy of oral Calcitonin in the treatment of osteoarthritis of the knee is still in progress. In December 2009, the DMC conducted a futility analysis of one-year data for all patients enrolled in this two-year study, including assessments of safety and efficacy parameters, and recommended to continue with such study.
Nordic Bioscience currently plans to continue the clinical program of oral Calcitonin in osteoarthritis, including both Phase III study 2301 and Phase III study 2302.
Novartis and Nordic Bioscience are expected to continue to work together to assess next steps once the final data of study 2301 is available. This data is expected to be available in 4Q-2010.
Additionally, Nordic Bioscience currently intends to continue the clinical program of oral Calcitonin in osteoporosis.