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Patient Enrollment Initiated for Phase 3 Trial of Pexelizumab

CHESHIRE, Conn., July 20 /PRNewswire-FirstCall/ -- Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) announced today that they and their collaboration partner for pexelizumab, Procter & Gamble Pharmaceuticals, Inc. (P&GP), have initiated patient enrollment for the pivotal Phase III PRIMO-CABG-2 trial in patients undergoing coronary artery bypass graft surgery. Alexion reported on June 14th that they, together with P&GP, had reached agreement with the FDA on the design for the PRIMO-CABG-2 study under the Special Protocol Assessment (SPA) process. It is expected that, if successful, this trial will complete the filing package that will serve as the primary basis of review for the approval of a Biologics License Application for the CABG indication.

The "Pexelizumab for Reduction of Infarction and MOrtality in Coronary Artery Bypass Graft surgery" (PRIMO-CABG-2) pivotal Phase III trial, will examine the effects of pexelizumab on the composite endpoint of death or myocardial infarction at 30 days post procedure in moderate to high risk CABG surgery patients with or without concomitant valve surgery during cardiopulmonary bypass. The study is expected to enroll approximately 4,000 patients in North America and Europe over the next 12-15 months. PRIMO-CABG-2 represents the second Phase III clinical trial conducted in CABG patients. Alexion and P&GP are jointly executing the trial.

In addition, enrollment was initiated in the pivotal Phase III APEX-AMI trial in patients experiencing acute myocardial infarction treated with primary percutaneous intervention (PCI). The "Assessment of PEXelizumab in Acute Myocardial Infarction" (APEX-AMI) pivotal Phase III trial, will examine the effects of pexelizumab on death at 90 days post procedure in patients undergoing percutaneous intervention for acute myocardial infarction. The study is expected to enroll approximately 8,500 patients in North America, Europe, Australia and New Zealand over the next 24-36 months. APEX-AMI represents the first Phase III trial of pexelizumab in patients experiencing acute myocardial infarction. Initiation of this study triggers a milestone payment to Alexion from P&GP. Alexion and P&GP are jointly executing the trial.

"Having completed the SPA process, we are pleased to be moving quickly to the enrollment of patients in these studies," said Leonard Bell, M.D., Chief Executive Officer of Alexion. "Of particular importance is the initiation of the PRIMO-CABG-2 study, which we will strive to complete in the second half of 2005 and which is designed to provide data which, if positive, will provide a solid basis to support a biological license application for the CABG indication."

If approved, pexelizumab would represent the first of a new class of anti-inflammatory therapeutics (terminal complement inhibitors) for patients undergoing CABG surgery and for patients undergoing PCI for acute myocardial infarction.

Source: Alexion Pharmaceuticals

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