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www.fdanews.com/articles/81564-avant-completes-enrollment-of-tp10-phase-iib-study

AVANT COMPLETES ENROLLMENT OF TP10 PHASE IIB STUDY

October 11, 2005

Avant Immunotherapeutics has completed enrollment of the Phase IIb trial of its complement inhibitor, TP10, in female subjects undergoing high-risk cardiac surgery utilizing cardiopulmonary bypass (CPB). The objective of this double-blind, placebo-controlled study is to assess the safety and treatment effect of TP10 as compared to placebo in reducing the incidence of death or heart attack that occurs in cardiac surgery patients on CPB, thus potentially improving postoperative outcomes.

TP10 is a human recombinant protein that blocks complement activation, an acute inflammatory process that can lead to tissue damage and increased surgical complications that can impact patient survival. Results of a previous Phase II study demonstrated the ability of TP10 to significantly decrease postsurgical heart attacks and deaths in male CPB patients, although not in women.