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Biotech / Medical : Alexion Pharmaceuticals, Inc. (ALXN) -- Ignore unavailable to you. Want to Upgrade?

To: Ian@SI who wrote (380)	11/10/2003 1:19:57 PM
From: Ian@SI	Read Replies (1) \| Respond to of 824

part II of press release ... Alexion Announces Results of Phase III PRIMO-CABG Trial Presented At the American Heart Association's Scientific Sessions 2003 ... Statistically significant reductions were achieved with pexelizumab in each of the six different pre-specified measures of perioperative myocardial damage in the overall Intent to Treat population (all p<0.05) as well as in the CABG-only subpopulation (all p<0.05). "The clinical data from PRIMO-CABG support the view that the terminal complement inhibitor pexelizumab may beneficially impact inflammation and ischemia/reperfusion, and thereby reduces the frequency and severity of myocardial infarction following CABG surgery," said Dr. Verrier, Chairman of the PRIMO-CABG Steering Committee. "The significant reduction in the Death/MI composite in the ITT population is very encouraging. As the CABG patient population continues to evolve into a population with greater co-morbidities at baseline, the additional analyses, which showed an encouraging effect of pexelizumab in higher risk study patients, are supportive of the potential for pexelizumab to become a useful adjunctive therapy in the care of the cardiac surgery population." The encouraging effect of pexelizumab on postoperative morbidity and mortality appeared to persist, as pexelizumab was associated with a 25% reduction in 90 day mortality [placebo 4.8% vs. pexelizumab 3.6%, p=.096], an important prospectively defined secondary endpoint. The clinical meaningfulness of postoperative myocardial infarction was determined in an exploratory analysis. The presence of postoperative myocardial infarction (consisting in the trial of Q wave MI and non-Q wave MI) was determined by a clinical events committee of expert cardiologists. In this analysis, it was determined that Day 4 MI predicted 6-month mortality (p<0.0005) such that approximately 1-out-of-every-6 patients with a Day 4 MI died by 6 months, a four-fold increase vs. patients without a Day 4 MI (Day 4 MI mortality 16.3% vs. No Day 4 MI mortality 4.0%).