Vasogen's phase 3 results for Celacade in chronic heart failure to be released later this month

By E. Janene Geiss

Philadelphia, June 14 - Vasogen Inc. said Wednesday that results of its pivotal phase 3 Acclaim trial of its Celacade technology in advanced chronic heart failure are expected to be released later this month.

The trial enrolled 2,400 patients at 176 cardiac centers throughout North America, Europe and Israel, according to a company news release.

The study is a double-blind, placebo-controlled trial designed to further assess the impact of Vasogen's Celacade technology on the risk of death and cardiovascular hospitalizations in advanced chronic heart failure patients and to support the regulatory approval process in North America and commercialization in North America and Europe.

The start of the trial was based on the success of a double-blind, placebo-controlled phase 2 trial in advanced chronic heart failure patients conducted at the Cleveland Clinic, Baylor College of Medicine, the Texas Heart Institute and the University of Montreal.

The key finding from the trial was a significant reduction in the risk of death and all-cause hospitalization for patients receiving treatment using Vasogen's Celacade technology compared to those receiving placebo treatments.

Results also showed a significant reduction in the composite endpoint of all-cause mortality or any hospitalization in the Celacade group, compared to a placebo, officials said.

The company also said results of the phase 3 trial have been accepted for presentation at a session of the World Congress of Cardiology 2006, being held from Sept. 2 through Sept. 6 in Barcelona, Spain.

Vasogen is a Mississauga, Ont., biopharmaceutical company focused on development of technologies targeting the chronic inflammation underlying cardiovascular and neurological disease.

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