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Alexion pexelizumab Phase III trials

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Alexion and partner Procter & Gamble will conduct a confirmatory Phase III coronary artery bypass graft surgery trial with pexelizumab as well as a pivotal Phase III trial in acute myocardial infarction in "upcoming months." The company downplayed the need for an additional CABG trial when it presented results from the failed Phase III PRIMO-CABG trial, suggesting that the initial trial could support the AMI indication (1Pharmaceutical Approvals Monthly Sept. 1, 2003, p. 21). Alexion presented a meta-analysis at the American College of Cardiology Scientific Sessions on March 8, showing a significant reduction of 30-day mortality in pooled data from the Phase II AMI trials and the Phase II and Phase III CABG trials, although results were not significant in any of the individual studies...

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