Pexelizumab being investigated to reduce perioperative mortality in patients undergoing CABG-CPB surgery
Aug 11, 2005 - 1:04:38 AM
Alexion Pharmaceuticals, Inc. and Procter & Gamble Pharmaceuticals (P&GP), a division of The Procter & Gamble Company, announced today the completion of enrollment for the pivotal Phase III PRIMO-CABG2 efficacy trial of pexelizumab. This agent is being investigated for reducing mortality and myocardial infarction (heart attack) following coronary artery bypass graft (CABG) surgery.
The "Pexelizumab for Reduction of Infarction and Mortality in Coronary Artery Bypass Graft surgery 2" (PRIMO-CABG2) pivotal Phase III trial is examining the effect of pexelizumab in approximately 4,250 patients undergoing CABG surgery with or without concomitant valve surgery during cardiopulmonary bypass. This study is being conducted in six countries in Europe and North America, including the United States, and results are expected by the end of 2005.
"We are pleased to announce the completion of enrollment in the PRIMO- CABG2 trial ahead of our previously announced schedule," said Leonard Bell, M.D., Chief Executive Officer of Alexion. "The enthusiastic response of our multinational clinical investigators allowed for a rapid completion of enrollment in this large acute cardiovascular trial and we greatly appreciate the efforts of all those involved in the study."
Alexion and P&GP previously reported that they had reached agreement with the U.S. Food and Drug Administration under the special protocol assessment process on the design of the PRIMO-CABG2 study. It is expected that, if successful, this trial will form the primary basis of review for the approval of a Biological License Application for pexelizumab for the CABG indication.
Pexelizumab is an Alexion-engineered monoclonal antibody fragment designed to inhibit complement-mediated tissue damage associated with reperfusion injury and inflammation that occurs during open heart surgery. If approved, pexelizumab would represent the first of a new class of therapeutics called terminal complement inhibitors for the reduction of death and perioperative myocardial infarction in patients undergoing CABG-CPB surgery.
"If approved, pexelizumab would represent a new approach to improving outcomes for patients undergoing CABG surgery," said Mark Collar, President, P&G Global Pharmaceuticals and Personal Health. "We are pleased with the seamless execution of this pivotal program with our partner Alexion and with the opportunity to quickly advance this potential novel therapy."
Alexion and P&GP also continue to study pexelizumab in patients experiencing acute myocardial infarction (AMI) treated with primary percutaneous intervention in the pivotal Phase III APEX-AMI trial. APEX-AMI is actively enrolling patients in North America, Europe, Australia and New Zealand.
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