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Vasogen Announces 2007 Year-End Results
Date:1/16/2008

journal. As

previously reported by Vasogen, 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.

- We entered into a collaboration with Grupo Ferrer Internacional,

S.A., a leading European pharmaceutical and medical devices company,

to commercialize Celacade for the treatment of chronic heart failure

in specified countries of the European Union and in certain Latin

American countries. In December 2007, Ferrer received initial orders

for Celacade in Germany.

- The Food and Drug Administration strongly recommended that we conduct

a confirmatory study (ACCLAIM-II) in NYHA Class II heart failure

patients to support a Pre-market Approval filing for Celacade in the

United States. The FDA also recommended that we utilize a Bayesian

statistical approach for designing the confirmatory trial as it would

allow for the borrowing of statistical power from the ACCLAIM study.

This approach has the potential to substantially reduce the number of

patients required for a confirmatory study, as well as the cost and

duration.

- James B. Young, MD, Chairman, Division of Medicine at the Cleveland

Clinic Foundation and Medical Director, Kaufman Center for Heart

Failure, was appointed the Global Principal Investigator and Chairman

of the Steering Committee for ACCLAIM-II.

- Chris Waddick, MBA, CMA, was appointed President, CEO, and a Member

of the Board of Directors of our Company. Mr. Waddick has held a

series of progressive senior management positions at Vasog
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SOURCE Vasogen Inc.
Copyright©2008 PR Newswire.
All rights reserved

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