Complement inhibitor decreases heart attacks and death in men following cardiac surgery

NEEDHAM, MA (November 11, 2003): Use of an investigational therapeutic under development by AVANT Immunotherapeutics, Inc. (Nasdaq: AVAN) effectively inhibited harmful complement-mediated inflammation in men undergoing cardiac surgery involving cardiopulmonary by-pass (open heart surgery), leading to a significant reduction in post-surgical deaths and heart attacks. Results of a Phase II trial of AVANT's soluble complement inhibitor, TP10 (sCR1), were presented today by principal investigator Harold L. Lazar, M.D., Boston University School of Medicine at the Annual Scientific Meeting of the American Heart Association in Orlando, Florida.

"Activation of the complement system during cardiopulmonary by-pass causes an acute, inflammatory reaction that can damage tissues, contributing to post-operative heart attacks and increased surgical complications that can impact patient survival," said Dr. Lazar. "This study showed that treatment with TP10, a potent inhibitor of complement activation, can limit this harmful inflammatory response, leading to improved post-surgical outcomes following cardiac surgery."

The multi-center, placebo-controlled, double-blind study enrolled 564 high-risk patients undergoing open heart surgery, who received a single intravenous dose of TP10 immediately prior to cardiopulmonary by-pass. Approximately 72% of those patients enrolled were male and approximately 28% were female. TP10 significantly inhibited complement activation in all treated patients compared to placebo for up to three days after surgery. Male patients receiving TP10 furthermore had a significant decrease from 32% to 20% (p=0.01) in the primary endpoint of the study, a composite of death, myocardial infarction (heart attack), prolonged (24 hours or more) intra-aortic balloon pump support, and prolonged (24 hours or more) intubation. Male patients receiving TP10 also showed a significant decrease in the combined endpoint of death or myocardial infarction from 27%

Contact: Joan Kureczka
Kureczka/Martin Associates

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