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
- 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
- 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
|SOURCE Vasogen Inc.|
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