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Vasogen Announces Third Quarter 2007 Results

ing our ACCLAIM results, the agency strongly

recommended that we conduct a confirmatory trial ("ACCLAIM-II") of

Celacade in NYHA Class II heart failure patients to support a

Pre-market Approval submission for the purpose of achieving

regulatory approval in the United States. The FDA also recommended

that we use a Bayesian approach in the design of the confirmatory

trial. The FDA indicated that they were recommending this approach

specifically because it would allow us to borrow power from the

ACCLAIM trial and also because it has the potential to substantially

reduce the sample size required for a confirmatory study. The planned

trial design for ACCLAIM-II indicates that as few as 300 patients

could provide sufficient data to confirm the finding of the

phase III ACCLAIM trial which demonstrated a 39% reduction

(p=0.0003) in the risk of death or cardiovascular

hospitalizations for patients receiving Celacade in the large

pre-specified subgroup of 689 NYHA class II heart failure patients.

Furthermore, the use of an adaptive clinical trial design also

provides the flexibility to increase the sample size up to

600 patients, should additional data be required. We are preparing to

meet with the FDA again, with the objective of obtaining formal

regulatory agreement with respect to our proposed trial design prior

to the end of the year.

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

Clinic Foundation and Medical Director, Kaufman Center for Heart

Failure, has agreed to be the Global Principal Investigator and

Chairman of the Steering Committee for the planned ACCLAIM-II study.

Dr. Young, who has played a leading role in numerous multi-center

clinical trials focusing on heart failure and

SOURCE Vasogen Inc.
Copyright©2007 PR Newswire.
All rights reserved

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