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Vasogen Announces First Quarter 2008 Results

rnal of Neuroscience (Vol 27, pp.294-

300, 2008).

- The results from the phase III ACCLAIM trial of our Celacade System

in patients with chronic heart failure were published in the

January 19th issue of The Lancet (Lancet 2008; 371: 228-36), a world-

leading medical journal. As we previously reported, while the trial

did not meet its primary endpoint, a key finding from the ACCLAIM

trial was a 39% reduction in the risk of death or cardiovascular

hospitalizations for a large pre-specified subgroup of patients with

NYHA Class II heart failure who received Celacade therapy, compared

to patients receiving placebo.

- On March 14, 2008, we had a teleconference with the FDA to discuss

and clarify the recent comments from the agency regarding the use of

a Bayesian approach for ACCLAIM II, a clinical trial which is being

planned to support an application for U.S. market approval of the

Celacade System for the treatment of patients with New York Heart

Association ("NYHA") Class II heart failure. The teleconference with

the FDA follows our announcement on March 3rd, stating that the FDA

disagrees with the use of a Bayesian approach for the planned ACCLAIM

II study. This is contrary to the FDA's original communication to us

recommending a Bayesian study design. We have prepared and submitted

a written response to the FDA's comments with respect to the use of a

Bayesian approach in ACCLAIM II.

- Grupo Ferrer Internacional, S.A. ("Ferrer"), our European marketing

partner, has the right to market Celacade for the treatment of

chronic heart failure in certain countries of the European Union

("E.U.") and Latin America. Celacade has already received E.U.

regulatory approval as a medical device under the CE Mark, which

SOURCE Vasogen Inc.
Copyright©2008 PR Newswire.
All rights reserved

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