Published on December 10, 2009 at 10:54 AM
Emisphere Technologies, Inc. (OTC BB:EMIS) today announced that an
independent Data Monitoring Committee (“DMC”) informed Novartis and its
partner Nordic Bioscience about their recommendation to proceed with the
Osteoporosis (“OP”) Phase 3 Study 2303 and the Osteoarthritis (“OA”)
Phase 3 Study 2301 exploring the safety and efficacy of an oral
formulation of salmon calcitonin to treat patients with osteoporosis and
osteoarthritis of the knee.
This recommendation is based on a futility analysis of one-year data for
all patients enrolled in the study for 12 months and 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 to proceed with the
studies to evaluate the efficacy and safety profile of oral calcitonin
at two years as planned.
SOURCE Emisphere Technologies, Inc.