ALEXION REPORTS PHASE III RESULTS FOR PRIMO-CABG2 TRIAL.
Pexelizumab, a terminal complement inhibitor, is a monoclonal antibody fragment that inhibits complement-mediated tissue damage. The Phase III trial titled Pexelizumab for Reduction of Infarction and Mortality in Coronary Artery Bypass Graft Surgery 2 (PRIMO-CABG2), included approximately 4,250 patients, and compared the safety and efficacy of pexelizumab against that of placebo in reducing heart attack and death following CABG surgery with or without concomitant valve surgery. Alexion expects that the trial results will be presented at an upcoming scientific meeting. The trial was conducted at approximately 250 U.S. and international study sites, and was sponsored jointly by Alexion and Procter and Gamble Pharmaceuticals.
"We are clearly disappointed that pexelizumab did not meet its primary endpoint in PRIMO-CABG2," said Leonard Bell, M.D., CEO of Alexion. "We look forward to completing an analysis of the data and obtaining a more in-depth understanding of these results."
Alexion is assessing the implications of the results of PRIMO-CABG2 on its second international pivotal phase III study of pexelizumab, the APEX-AMI trial, which is investigating the benefits of using pexelizumab in patients experiencing a heart attack who are treated with primary percutaneous coronary intervention (PCI), or angioplasty. The APEX-AMI trial has enrolled over 3,000 patients at more than 300 U.S. and international study sites.
Alexion remains on track to complete treatment in the TRIUMPH Phase III pivotal trial with its lead drug candidate eculizumab in the orphan blood disorder Paroxysmal Nocturnal Hemoglobinuria ("PNH"). Alexion expects topline results from TRIUMPH during the first quarter of 2006.
About Alexion (NASDAQ:ALXN)
Alexion is engaged in the discovery and development of therapeutic products aimed at treating patients with a wide array of severe disease states, including hematologic and cardiovascular disorders, autoimmune diseases and cancer. Alexion's two lead product candidates, pexelizumab and eculizumab, are currently undergoing evaluation in several clinical development programs, including two Phase III trials of eculizumab for the treatment of paroxysmal nocturnal hemoglobinuria (PNH), a Phase III trial of pexelizumab in coronary artery bypass graft (CABG) surgery patients undergoing cardiopulmonary bypass (trial completed), and a Phase III trial of pexelizumab in acute myocardial infarction (AMI) patients. The pexelizumab trials are conducted in collaboration with Procter & Gamble Pharmaceuticals.
Under the Special Protocol Assessment process, the FDA has agreed to the design of protocols for the Phase III pexelizumab trials that could, if successful, serve as the primary basis of review for approval of licensing applications for the two indications. Preliminary results from the phase III trial of pexelizumab in CABG patients indicate that the trial is unlikely to support filing for licensing approval of pexelizumab in the CABG indication. Also under the Special Protocol Assessment process, the FDA has agreed to the design of protocols for the two trials of eculizumab in PNH patients that could, if successful, serve as the primary basis of review for approval of a licensing application for eculizumab in the PNH indication. Eculizumab has also been studied in rheumatoid arthritis and membranous nephritis. Alexion is engaged in discovering and developing a pipeline of additional antibody therapeutics targeting severe unmet medical needs, through its wholly owned subsidiary.
For more information, visit http://www.alexionpharm.com or call 203/272-2596.
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|Date:||Jan 1, 2006|
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