Alexion Pharmaceuticals Reports Presentation of Additional Data From Its Pexelizumab COMMA Phase II Acute Myocardial Infarction Trial At the European Society of Cardiology Congress
Tuesday September 2, 7:30 am ET
- Reduction of death in patients with acute myocardial infarction treated with pexelizumab and percutaneous coronary intervention is independent of time to treatment-
CHESHIRE, Conn., Sept. 2 /PRNewswire-FirstCall/ -- Alexion Pharmaceuticals, Inc. (Nasdaq: ALXN - News) announced today that at the European Society of Cardiology Congress 2003 in Vienna, Austria, Paul Armstrong, M.D., FRCPC, FACC, FESC, Professor of Medicine (Cardiology), University of Alberta, Edmonton, Canada presented further data analysis from Alexion's Phase II Pexelizumab Acute Myocardial Infarction (AMI) Program, which was conducted in collaboration with Procter and Gamble Pharmaceuticals, Inc. Dr. Armstrong's presentation -- "Mechanism of Pexelizumab's Mortality Benefit in AMI Patients Treated with primary PCI (Percutaneous Coronary Intervention)" -- provides new information obtained by sub-analysis of the mortality data from the COMMA trial, or "Complement Inhibition in Myocardial Infarction Treated with PTCA". The preliminary results of the COMMA trial were presented at the American Heart Association Scientific Meeting's Late-Breaking Clinical Trials Plenary Session in November of 2002 and will be published in the AHA journal Circulation on September 9, 2003.
"This further analysis of the results from our earlier COMMA pexelizumab AMI trial, together with recent encouraging results with pexelizumab in heart surgery patients, underscore our enthusiasm for progressing pexelizumab development in the acute cardiac setting," stated Dr. Leonard Bell, Chief Executive Officer of Alexion.
The Phase II COMMA trial involved 814 patients with ST elevation AMI presenting within 6 hours of symptom onset who underwent primary PCI. In this study, pexelizumab bolus 2.0 mg/kg was administered over 10 minutes followed by an infusion of 1.0 mg/kg over 20 hours. As presented at the 2002 AHA Scientific Sessions, while pexelizumab did not significantly reduce infarct size, the primary endpoint of the trial, results indicated that pexelizumab did significantly reduce all cause mortality at 90 days by 70% (p=0.014): placebo mortality rate of 5.9% (16/271) versus pexelizumab bolus plus infusion group mortality rate of 1.8% (5/281). Patients who received only the bolus of pexelizumab had an intermediate mortality of 4.2% (11/262). Pexelizumab appeared to be well tolerated with the most common adverse events being chest pain, hypotension, nausea, and ventricular tachycardia.
The subanalysis revealed that pexelizumab's impact on mortality appeared to be sustained independent of time to treatment, ultimate infarct size, degree of infarct related coronary blood flow or the extent of heart muscle atrisk for infarction. These results imply that pexelizumab's mortality benefit in AMI patients undergoing primary PCI is achieved through novel alternative mechanisms that are related to its potent inhibition of the complement system.
"We found, as expected, that in patients undergoing percutaneous coronary intervention (PCI) and receiving placebo, the mortality rate increased from 5.6% to 10.4% as the time to treatment after symptom onset lengthened from the 0-2 hour window to the over 4-hour time window," reported Dr. Armstrong. "This observation is well supported by other acute myocardial infarction trials and it is well known to cardiologists that earlier reperfusion treatment of heart attacks yields lower mortality using today's state-of-the- art treatment. In contrast, for patients who received pexelizumab as a bolus- infusion adjunctive treatment on top of the state of the art PCI therapy, the mortality rate was substantially lower at 1.2% in the 0-2 hour window, and also remained low at 1.9% in the greater-than-4 hour window. This overall time-independent reduction in mortality is likely to be of substantial interest to practicing cardiologists who are constantly striving to improve care of heart attack victims. The mechanism of pexelizumab's mortality benefit is currently under investigation and is focused on a possible reduction of cardiac cell apoptosis, modulation of acute inflammation, inhibition of inducible nitric oxide synthase and favorable modulation of cardiac remodeling." |
