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.|
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