|Momenta Pharmaceuticals Announces Positive Results|
|By Staff and Wire Reports|
|Thursday, 24 September 2009 14:17|
"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.