Vasogen says Celacade failed to meet primary endpoint in phase 3 trial; endpoint met in patient subgroup

By Jennifer Lanning Drey

Eugene, Ore., June 26 - Vasogen Inc. announced that Acclaim, a 2,414-patient phase 3 clinical trial of its Celacade technology, did not meet its primary endpoint of significantly reducing the risk of death or first cardiovascular hospitalization for patients with advanced chronic heart failure.

However, the company also said Monday that Celacade did meet the endpoint in a subgroup of 692 patients with New York Heart Association class 2 chronic heart failure.

"While we are obviously very disappointed that Acclaim did not meet its primary objective, we are encouraged by the beneficial effect observed in the NYHA class 2 subgroup of patients," said David Elsley, president and chief executive officer of Vasogen, in a company conference call on Monday.

In the double blind, placebo controlled randomized Acclaim trial, the time of death or first cardiovascular hospitalization was not significantly different between the Celacade and placebo groups in the intention to treat population. In addition, there was no significant difference between the treatment groups for either of the components of the primary endpoint, according to a company news release.

Vasogen will continue to analyze the data from the Acclaim trial and will review the trial results with regulators and prospective partners, Elsley said during Monday's call.

In the pre-specified subgroup of patients with NYHA class 2 chronic heart failure, the time of death or first cardiovascular hospitalization was significantly reduced in the Celacade group compared to the placebo group, according to the release.

"The group of patients from the New York Heart Association class 2 heart failure represents a large, underserved patient population who are at risk for adverse cardiovascular outcomes, progression to more advanced disease and are a major driver of health care costs due to hospitalization," said Elsley, during Monday's call.

Vasogen said it will present the complete results from the Acclaim study at the World Congress of Cardiology 2006, being held Sept. 2-6 in Barcelona, Spain.

The Acclaim trial was performed at 176 cardiac centers throughout North America, Europe and Israel.

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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