Alexion Announces Results of Phase III PRIMO-CABG Trial Presented At the American Heart Association's Scientific Sessions 2003
CHESHIRE, Conn., Nov. 10 /PRNewswire-FirstCall/ -- Alexion
Pharmaceuticals, Inc. (Nasdaq: ALXN) announced today that Edward D. Verrier, M.D., William K. Edmark Professor and Chief of Cardiothoracic Surgery at the University of Washington, presented the Phase III trial results of the
investigational drug pexelizumab in patients undergoing coronary artery bypass graft ("CABG") surgery with cardiopulmonary bypass - "Pexelizumab for Reduction in Infarction and Mortality in Coronary Artery Bypass Graft Surgery," or PRIMO-CABG. The results were presented today at the Late Breaking Clinical Trials Session of the American Heart Association Scientific Sessions in Orlando, Florida. Alexion conducted the PRIMO-CABG trial together with Procter & Gamble Pharmaceuticals, and initially described top-line observations of the trial in a press release dated August 4, 2003. Alexion will host a conference call and web cast today at 3:00 p.m. EST to discuss the matters mentioned in this release.
The total Intent-to-Treat population (n=3,099) consisted of patients undergoing CABG-alone (n=2,746) and patients who had CABG together with cardiac valve surgery (n=353). The primary endpoint in this trial was the incidence of death or myocardial infarction ("Death/MI") at post-operative Day 30 in the subpopulation of study patients who had only CABG surgery (n=2,746).
The incidence of Death/MI, the primary endpoint, was reduced by 18% (11.8% placebo vs. 9.8% pexelizumab, p=0.069).
Although the primary endpoint was not met with statistical significance, pexelizumab did achieve statistically significant reductions in the same Death/MI endpoint in each additional secondary analysis:
* Day 30 in the overall Intent to Treat population (18% relative reduction; placebo 14.0%, pexelizumab 11.5%; p=0.030)
* Day 4 in the overall Intent to Treat population (24% relative reduction; placebo 11.9%, pexelizumab 9.1%; p=0.008)
* Day 4 in the CABG-only subpopulation (26% relative reduction; placebo 10.0%, pexelizumab 7.4%; p=0.014)
Additionally, pexelizumab achieved statistically significant reductions in the following Myocardial Infarction (MI) secondary analyses:
* Day 30 in the overall Intent to Treat population (18% relative reduction; placebo 12.0%, pexelizumab 9.8%; p=0.042)
* Day 30 in the CABG-only subpopulation (22% relative reduction; placebo 10.3%, pexelizumab 8.1%; p=0.036)
* Day 4 in the overall Intent to Treat population (24% relative reduction; placebo 11.1%, pexelizumab 8.4%; p=0.010)
* Day 4 in the CABG-only subpopulation (27% relative reduction; placebo 9.3%, pexelizumab 6.7%; p=0.012)
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