Alexion updates phase 3 results of Primo-CABG2 study

By Lisa Kerner

Erie, Pa., March 13 - Alexion Pharmaceuticals, Inc. updated results from its phase 3 Primo-CABG2 clinical trial with pexelizumab at the American College of Cardiology.

The company previously announced results in November showing that the drug reduced the primary endpoint, but did not meet the pre-specified threshold for statistical significance, according to an Alexion news release.

The Primo-CABG2 (Pexelizumab for Reduction of Infarction and Mortality in Coronary Artery Bypass Graft Surgery 2) trial enrolled 4,254 moderate-to-high risk coronary artery bypass graft (CABG) surgery patients at 249 sites and was sponsored jointly by Alexion and Procter and Gamble Pharmaceuticals.

Pexelizumab is a monoclonal antibody fragment that inhibits complement-mediated tissue damage.

Alexion said in the phase 3 trial, pexelizumab reduced the primary endpoint of the combined incidence of death or nonfatal myocardial infarction (heart attack) through postoperative day 30 (POD 30) following CABG surgery. Mortality through POD 30 was reduced from 4.6% in the placebo group to 3.8% in the pexelizumab group.

Myocardial infarction through POD 30 was reduced modestly with pexelizumab, which was well tolerated with an adverse event profile comparable to placebo.

"The PRIMO-CABG2 study did not replicate the significant reduction in myocardial infarction that was observed previously in PRIMO-CABG1 and therefore did not achieve statistical significance for the co-primary endpoint of death or myocardial infarction through POD 30," Dr. Peter K. Smith of Duke University said in the release.

"However, we continue to be encouraged by the consistent mortality benefit observed in the overall PRIMO-CABG program that appears to extend across all acute cardiovascular trials performed with pexelizumab to date."

Alexion said it expects results from its current APEX-AMI trial will assist in determining the future of pexelizumab therapy in acute cardiovascular disease.

The company announced in January that the APEX-AMI trial has enrolled over 5,000 patients at more than 300 U.S. and international study sites.

Alexion is a biotechnology company that develops and delivers drug therapies for patients with serious and life-threatening medical conditions, including hematologic diseases, cancer, cardiovascular diseases and autoimmune disorders.

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