Alexion Pharmaceuticals Inc has completed enrollment of its pivotal Phase III clinical trial of pexelizumab in approximately 3,000 patients undergoing coronary artery bypass graft (CABG) surgery with cardiopulmonary bypass (CPB). The Phase III program, if successful, will be a key component supporting an NDA filing with the U.S. Food and Drug Administration. The trial, conducted by Alexion and Procter & Gamble Pharmaceuticals, its partner in the development of pexelizumab, is referred to as "Pexelizumab for Reduction in Infarction and Mortality in Coronary Artery Bypass Graft Surgery," or "PRIMO-CABG."
"Completing enrollment of this Phase III pivotal trial for our lead drug candidate pexelizumab is an important milestone for Alexion," stated Leonard Bell, Chief Executive Officer of Alexion. "Full enrollment of this trial is significantly ahead of our aggressive internal schedule and we are very proud of the manner in which our clinical operations team executed enrollment of this large trial. Once follow-up patient visits and data collection are completed, we expect to analyze the data and report the results of this Phase III trial during the second half of this year."
In this randomized, placebo-controlled trial, approximately 3,000 patients, at more than 200 clinical sites, undergoing coronary artery bypass graft surgery with cardiopulmonary bypass were treated with either placebo or pexelizumab bolus followed by a continuous infusion over 24 hours. The Phase III trial is designed to assess the safety and efficacy of pexelizumab in reducing the combined incidence of death or myocardial infarction in this patient population.
Alexion is engaged in the discovery and development of therapeutic products aimed at treating patients with a wide array of severe disease states, including cardiovascular and autoimmune disorders, inflammation and cancer. Alexion's two lead product candidates, pexelizumab and eculizumab, are currently undergoing evaluation in several clinical development programs.
Alexion is developing pexelizumab, an antibody fragment, in collaboration with Procter & Gamble Pharmaceuticals. Together the firms have completed enrollment in a Phase III clinical study with pexelizumab in coronary artery bypass graft surgery (CABG) patients undergoing cardiopulmonary bypass (CPB), and have completed two large Phase II studies with pexelizumab in acute myocardial infarction patients. Alexion's other lead product candidate, eculizumab, is being studied in a Phase IIb trial for the treatment of rheumatoid arthritis. In addition, eculizumab is in a Phase II clinical trial in membranous nephritis and in earlier stage clinical development for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) and dermatomyositis.