Millennium Pharmaceuticals Inc. started a 6,000-patient Phase III trial of Integrilin in ST-segment elevation myocardial infarction (STEMI), or heart attack patients.
The trial, referred to as ADVANCE MI (addressing the value of facilitated angioplasty after combination therapy or eptifibatide monotherapy in acute myocardial infarction), will be conducted at 400 sites across North America and Western Europe, and is expected to be completed in 2004. It is designed to evaluate the safety and efficacy of Integrilin alone or in combination with reduced-dosed tenecteplase, a fibrinolytic, or clot-busting treatment followed by percutaneous coronary angioplasty within four hours in heart attack patients.
Arthur Hiller, general manager of the Millennium cardiovascular franchise, told BioWorld Today that a large trial is necessary to "demonstrate statistical significance because the incidence of events is actually fairly low because we've gotten better and better at treating patients who come in with heart attacks. You need a lot of patients in a trial just to demonstrate the statistical significance between the two arms."
The study's primary endpoint is an improvement in patient survival and a reduction in the rate of congestive heart failure.
Integrilin (eptifibatide), which had generated revenues of $222.6 million worldwide through the third quarter this year, is marketed for the treatment of patients with acute coronary syndrome, including patients who are to be managed medically and those undergoing percutaneous coronary intervention (PCI) and for the treatment of patients undergoing PCI, including those undergoing intracoronary stenting.
Millennium, of Cambridge, Mass., acquired Integrilin in a $2 billion stock merger with COR Therapeutics Inc. about a year ago. By way of the merger, Millennium inherited COR's portion of a 50-50 profit-sharing deal with Schering-Plough Corp., of Madison, N.J. Outside the U.S., Millennium receives double-digit royalties on sales. (See BioWorld Today, Dec. 7, 2001; Oct. 31, 2001; and April 12, 1995.)
Hiller said Millennium is preparing to initiate a Phase II trial of Integrilin in coronary artery bypass grafting, and the company is working with the National Institutes of Health to possibly study Integrilin in stroke patients.