Alexion's phase 3 trial of pexelizumab in heart attack after bypass fails to meet its endpoint

By E. Janene Geiss

Philadelphia, Nov. 23 - Alexion Pharmaceuticals, Inc. said Wednesday that results from its phase 3 Primo-CABG2 clinical trial with pexelizumab show that the drug reduced the primary endpoint, but did not meet the prespecified threshold for statistical significance.

The primary endpoint was the combined incidence of nonfatal myocardial infarction (heart attack) or death through 30 days following coronary artery bypass graft surgery in moderate-to-high risk patients, officials said in a company news release.

"We are clearly disappointed that pexelizumab did not meet its primary endpoint in Primo-CABG2," chief executive officer Leonard Bell said in the release. "We look forward to completing an analysis of the data and obtaining a more in-depth understanding of these results."

Pexelizumab, a terminal complement inhibitor, is a monoclonal antibody fragment that inhibits complement-mediated tissue damage.

The phase 3 trial included about 4,250 patients at 250 U.S. and international sites and compared the safety and efficacy of pexelizumab against that of a placebo in reducing heart attack and death following bypass graft surgery with or without concomitant valve surgery, officials said.

Alexion said it expects the trial results will be presented at an upcoming scientific meeting. The trial was sponsored jointly by Alexion and Procter and Gamble Pharmaceuticals.

Alexion is assessing the implications of the results of Primo-CABG2 on its second international pivotal phase 3 study of pexelizumab, the APEX-AMI trial, which is investigating the benefits of pexelizumab in patients experiencing a heart attack who are treated with primary percutaneous coronary intervention, or angioplasty, officials said.

The APEX-AMI trial has enrolled over 3,000 patients at more than 300 U.S. and international study sites.

Alexion said it remains on track to complete treatment in the Triumph phase 3 pivotal trial with its lead drug candidate eculizumab in the orphan blood disorder Paroxysmal Nocturnal Hemoglobinuria. Alexion said it expects topline results from Triumph during the first quarter of 2006.

Alexion is a Cheshire, Conn.-based pharmaceutical company.

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