- 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.|
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