Emisphere Technologies, Inc, of Tarrytown, New York, has announced that an independent pilot study of daily salmon calcitonin therapy, ingested by the patient via Emisphere's oral delivery eligen® technology (consisting of synthetic chemical drug delivery agents), has shown positive clinical results in patients with knee osteoarthritis (OA).

The randomized, double-blind, placebo-controlled parallel study was conducted for 84 days, with patients receiving either placebo (n = 16), 0.5 mg drug (n = 17), or 1 mg drug (n = 18). 

According to study investigators Daniel Manicourt, MD, and Jean-Pierre Devogelaer, MD, of the department of rheumatology at University Hospital St-Luc, University Catholique de Louvain, in Brussels, Belgium, clinical efficacy (pain, function, and stiffness) was observed in both drug groups, and biochemical markers of joint degradation—including urinary levels of type I and type II collagen C telopeptide, serum levels of type II collagen neoepitope C2C, matrix metalloproteinase-3, collagenase-3 (matrix metalproteinase-13), and hyaluronan—were markedly reduced in the 1 mg dose arm.

Emisphere's licensing partner, Novartis Pharma AG, which supplied the salmon calcitonin, expects to begin pivotal phase III clinical studies of oral salmon calcitonin in both osteoporosis and OA in the first quarter of 2006. In a phase IIa study of 277 patients treated for 3 months, Novartis reported that oral salmon calcitonin achieved statistically significant results related to a decrease in markers of bone turnover. Novartis also published results from a nested study of 152 of the 277 subjects in the phase IIa study demonstrating a statistically significant, dose-dependent decrease in markers of cartilage degradation.

Emisphere, a publicly traded development-stage biopharmaceutical company focused on the oral delivery of otherwise injectable drugs, says that its eligen technology has enabled the oral delivery of proteins, peptides, macromolecules, and charged organics. Advanced oral formulations or prototypes of salmon calcitonin, heparin, insulin, parathyroid hormone, human growth hormone, and cromolyn sodium are now in clinical trials.

—A. Techman