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Phase 3 Pexelizumab Trial Demonstrates Significant Reductions in Myocardial Infarction Endpoint
CHESHIRE, Conn., May 18 /PRNewswire-FirstCall/ -- Alexion Pharmaceuticals Inc. today announced that results of its first Phase III clinical trial of pexelizumab, an investigational drug, have been published in the May 19th, 2004 issue of the Journal of the American Medical Association (JAMA). The "Pexelizumab for Reduction in Infarction and MOrtality in Coronary Artery Bypass Graft Surgery" trial, or PRIMO-CABG, was a double- blinded and placebo-controlled, 3,099 patient study that examined the efficacy of pexelizumab, a terminal complement inhibitor, in patients undergoing coronary artery bypass graft (CABG) surgery with cardiopulmonary bypass. Alexion conducted the PRIMO-CABG trial together with Procter & Gamble Pharmaceuticals and initially reported a summary of the trial observations at the Late Breaking Clinical Trials Session of the American Heart Association Scientific Sessions in Orlando Florida on November 10th 2003.
"The clinical data from PRIMO-CABG support the view that pexelizumab may beneficially impact inflammation and ischemia/reperfusion, thereby reducing the frequency and severity of myocardial infarction following CABG surgery," said Dr. Edward Verrier, the manuscript's lead author, Professor in the Division of Cardiothoracic Surgery at the University of Washington School of Medicine and Chairman of the PRIMO-CABG Steering Committee. "The significant reduction in the Death/MI composite in the intent to treat population is very encouraging, and the robustness of pexelizumab's potential clinical benefit was demonstrated by the sustained Death/MI reduction through six months. Based on these preliminary results, my colleagues and I on the steering committee look forward to the start of PRIMO-CABG-2 to confirm the safety and efficacy of pexelizumab in CABG patients."
The total Intent-to-Treat population (n=3,099) consisted of patients undergoing CABG-only (n=2,746) and patients who had CABG together with cardiac valve surgery (n=353). Pexelizumab completely blocked terminal complement activity for 24 hours. The primary endpoint in this trial, the incidence of death or myocardial infarction ("Death/MI") at post-operative day 30 in the CABG-only subpopulation (n=2,746), was reduced by 18% (placebo 11.8% vs. pexelizumab 9.8%, p=0.069). Although the primary endpoint did not meet the pre-specified criteria for statistical significance (i.e. p
The pexelizumab regimen appeared to be well-tolerated, with the most common serious adverse events observed being post-operative wound infection, pneumonia, respiratory failure, and pleural effusion. The most common adverse events observed were atrial fibrillation, anemia, nausea, and post-operative pain. Serious and common adverse event rates appeared to be similar between placebo and pexelizumab in the study population.
"It is extremely gratifying that the PRIMO-CABG trial was selected for publication in the Journal of the American Medical Association," said Dr. Leonard Bell, M.D., Chief Executive Officer of Alexion Pharmaceuticals. "We are very encouraged by the results of this trial, and this publication will serve to increase the interest in pexelizumab and provide support for the confirmatory pivotal PRIMO-CABG-2 trial. Together with our partner Procter & Gamble Pharmaceuticals, we expect to commence enrollment in the coming months."
To review the full article, click here: https://jamanetwork.com/journals/jama/fullarticle/198762
Source: Alexion Pharmaceuticals Inc.