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Emisphere Reports DMC Recommendation (OTC:EMIS)

By Becky Shadle on 12/15/2009 – 7:45 am PSTLeave a Comment

Emisphere Technologies Inc (OTC:EMIS) has announced that an independent Data Monitoring Committee (DMC) has informed Novartis and its partner Nordic Bioscience about their recommendation to proceed with the Osteoporosis (OP) Phase 3 study and the Osteoarthritis (OA) Phase 3 Study exploring the safety and efficacy of an oral formulation of salmon calcitonin to treat patients suffering with osteoporosis and osteoarthritis of the knee.

Emisphere is a biopharmaceutical company that focuses on the unique and improved delivery of therapeutic molecules or nutritional supplements using its proprietary Eligen Technology. The Eligen Technology can be applied to the oral route of administration as well as other delivery pathways such as buccal, rectal, inhalation, intra-vaginal or transdermal. These delivery agents facilitate and enable the transport of therapeutic macromolecules (such as proteins, peptides, and polysaccharides) and poorly absorbed small molecules across biological membranes, such as the small intestine.

This recommendation is based on an analysis of one year data for all patients enrolled in the study for the period of 12 months and also includes both an assessment of safety and efficacy parameters. Based on this interim analysis, DMC is of the opinion that there are no major or unexpected safety concerns and recommends proceeding with the studies to test the efficacy and safety profile of oral calcitonin at two years as planned.

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