ENROLLMENT COMPLETED IN CARDIAC BYPASS SURGERY TRIAL
Alexion Pharmaceuticals and Procter & Gamble have announced 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) 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 U.S., and results are expected by the end of the year.
Pexelizumab is a 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.