Alexion Pharmaceuticals Inc reported preliminary results of its Phase III study in a large, multinational trial consisting of greater than 3,000 patients undergoing coronary artery bypass graft (CABG) surgery with cardiopulmonary bypass, a study referred to as "Pexelizumab for Reduction in Infarction and Mortality in Coronary Artery Bypass Graft Surgery," or PRIMO-CABG.
The primary endpoint in this trial was a composite of the incidence of death or myocardial infarction, measured at 30 days post-procedure, in patients undergoing CABG without concomitant valve surgery.
Although there was reduction in the primary endpoint, it was not achieved with statistical significance. However, key pre-specified secondary endpoints consisting of the same composite in the total study population, which included all patients undergoing CABG with or without concomitant valve surgery, were achieved. Several other pre-specified secondary endpoints were met as well.
The company announced that further details of PRIMO-CABG will be provided after all data analyses are complete, and will be presented by Dr. Verrier in the Late-Breaking Clinical Trials Session of the 2003 Scientific Sessions Meeting of the American Heart Association in Orlando, Florida, during the second week of November. Dr. Edward D. Verrier is William K. Edmark Professor and Chief of Cardiovascular Surgery at the University of Washington, and Chairman of the PRIMO-CABG Steering Committee.
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 a Phase III clinical study with pexelizumab in CABG patients undergoing cardiopulmonary bypass, and two large Phase II studies with pexelizumab in acute myocardial infarction patients.
In addition, eculizumab is currently in Phase II clinical trials in rheumatoid arthritis and membranous nephritis, and has been evaluated in pilot programs for the treatment of paroxysmal nocturnal hemoglobinuria and dermatomyositis. Alexion is engaged in discovering and developing a pipeline of additional antibody therapeutics targeting severe unmet medical needs, through its wholly owned subsidiary, Alexion Antibody Technologies Inc.