Emisphere announces positive results in trial of Oral CT with eligen for osteoarthritis

New York, Dec. 12 - Emisphere Technologies, Inc. said clinical data from a study of Novartis Pharma AG's oral salmon calcitonin (CT) using Emisphere's eligen technology for osteoarthritis showed successful results.

In addition to clinical efficacy, the treatment also markedly reduced the levels of several biochemical markers of joint metabolism, which all have been shown to have a pejorative prognostic value for osteoarthritis in longitudinal studies including large cohorts of patients.

"This pilot study ... demonstrated the ability of the 1 mg dose of our unique oral salmon calcitonin product to not only show clinical efficacy in the study, but also demonstrated a decrease in biochemical markers that have been correlated with continued joint degradation," said Michael M. Goldberg, chairman and chief executive officer of Emisphere Technologies, in a news release.

"Over the course of the 84-day study, the placebo patients had no statistically significant change in clinical scores while they had statistically significant increases in biochemical markers that have been correlated with continued joint degradation.

"We are encouraged by these results and look forward to Novartis commencing pivotal phase 3 studies of Oral CT in early 2006."

The work was carried out by Daniel Manicourt and Jean-Pierre Devogelaer of the department of rheumatology at the University Hospital St-Luc, Universite Catholique de Louvain in Brussels, Belgium, and presented at the 10th world congress of the Osteoarthritis Research Society International in Boston.

The randomized, double-blind, placebo-controlled, parallel study was conducted for three months. Patients received daily either a placebo, 0.5 mg of oral CT or 1 mg of oral CT.

Pain, function and stiffness were evaluated by Lequesne's algofunctional indices. The placebo group had no significant change. By day 84 there were significant decreases for the two oral CT groups to 10.6 for the 0.5 mg group and 9.6 for the 1 mg group from 15.4 initially.

Emisphere is a Tarrytown, N.Y., biopharmaceutical company working on the oral delivery of otherwise injectable drugs.

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