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Pivotal Phase III Trial to Test Lead Alexion Drug
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Business New Haven
1/21/2002
By: BNH
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CHESHIRE - Alexion Pharmaceuticals Inc. (NASDAQ: ALXN) announced earlier this month that it had commenced enrollment in the Phase III clinical trial of lead drug pexelizumab in approximately 3,000 patients undergoing coronary artery bypass graft (CABG) surgery with cardiopulmonary bypass (CPB). If successful, the Phase III program is expected to be sufficient to support registration of the drug with the U.S. Food & Drug Administration (FDA). The trial, to be 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.'”
In a randomized, placebo-controlled multi-center trial, some 3,000 patients undergoing coronary artery bypass graft surgery with cardiopulmonary bypass will be treated with either placebo or pexelizumab 2.0 mg/kg bolus followed by a continuous 24 hour infusion. The Phase III trial will assess the safety and efficacy of pexelizumab in reducing the combined incidence of death and myocardial infarction in this patient population.
According to the American Heart Association, approximately 550,000 cardiopulmonary pulmonary bypass procedures were performed in the U.S. in 1998.
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