Vasogen's phase 3 Celacade trial in patients with heart failure set to be completed by year-end

By Angela McDaniels

Seattle, Nov. 14 -Vasogen Inc. said that the phase 3 trial of its Celacade technology in patients with advanced chronic heart failure has reached its objective of 701 primary endpoint events, defined as either a death or first cardiovascular hospitalization.

Achieving this objective will allow the 2,400-patient, multinational trial to be completed by year-end, the company said.

The placebo-controlled phase 3 trial is intended to definitively assess the impact of Celacade technology on reducing the risk of death and cardiovascular hospitalizations in patients with advanced chronic heart failure and to support regulatory approval and market introduction in North America and Europe, the company said.

"We initiated [the trial] based on the results of our phase 2 trial in which Celacade demonstrated an impressive reduction in the risk of death and hospitalization in advanced chronic heart failure patients," said lead investigator James Young of The Cleveland Clinic Foundation in a company news release.

Toronto-based Vasogen develops technologies that target the chronic inflammation underlying cardiovascular and neurological disease.

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