Momenta Pharmaceuticals Announces Positive Results Print E-mail
By Staff and Wire Reports   
Thursday, 24 September 2009 14:17
Momenta Pharmaceuticals, Inc. (Nasdaq:MNTA), a biotechnology company specializing in the characterization and engineering of complex drugs, today announced the results from the EMINENCE (Evaluation of M118 in Percutaneous Coronary Intervention) Phase 2 multicenter trial evaluating intravenous use of M118. The results were presented at the 21st Annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, sponsored by the Cardiovascular Research Foundation, being held in San Francisco, CA. Sunil V. Rao, M.D., co-principal investigator for the trial, presented the results as a "First Report" during a session on novel antithrombotic agents. Dr. Rao is an Assistant Professor of Medicine at the Duke University Medical Center and Director of the Cardiac Catheterization Laboratories at the Durham, NC Veterans Affairs Medical Center.

"M118, our first novel product engineered utilizing Momenta technology, was rationally designed to capture the positive attributes of both unfractionated heparin and low molecular weight heparin," commented Jim Roach, M.D., Chief Medical Officer at Momenta. "We are very pleased with the results from the EMINENCE trial, which support our belief that M118 has the potential to become the baseline anticoagulant of choice for treatment of patients diagnosed with acute coronary syndromes."

The primary objective of EMINENCE was to evaluate the safety and feasibility of utilizing M118 as an anticoagulant in the target population of patients with stable coronary artery disease (CAD) undergoing a percutaneous coronary intervention (PCI). Approximately 500 patients with stable CAD undergoing elective PCI were randomly assigned to receive treatment with one of three doses of intravenous M118 or a standard dose of unfractionated heparin (UFH).

The primary endpoint of the study was the combined incidence of clinical events defined as the composite of death, myocardial infarction (MI), repeat revascularization, and stroke (over thirty days); incidence of bleeding and thrombocytopenia (over the first 24 hours); and bailout use of glycoprotein IIb/IIIa inhibitors and catheter thrombus (during the procedure). Safety was also evaluated by assessing the incidence of adverse events and serious adverse events.




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