MISSISSAUGA, ON, Dec. 17 /PRNewswire-FirstCall/ - Vasogen Inc. (NASDAQ:VSGN; TSX:VAS) today provided an update on ACCLAIM-II, a confirmatory clinical trial which is designed to support an application for US market approval of the Celacade(TM) System for the treatment of patients with NYHA Class II heart failure.
The Company has been working diligently on the ACCLAIM-II study, including the establishment of a Steering Committee led by James B. Young, MD, Chairman, Division of Medicine at the Cleveland Clinic Foundation and Medical Director, Kaufman Center for Heart Failure; appointing Chairs for the Data and Safety Monitoring Board (DSMB) and Central Endpoint Committee (CEC); developing the study protocol, CEC adjudication plans, and other key trial documents, such as case report forms and informed consent forms; and selecting a contract research organization to assist with study execution.
Concurrent with the preparations for ACCLAIM-II, Vasogen has been working closely with the U.S. Food and Drug Administration (FDA) to finalize the protocol and the statistical analysis plan for the study using a Bayesian approach and adaptive clinical design. The planned study design indicates that as few as 300 patients could provide sufficient data to confirm the finding in the pre-specified sub-group of ACCLAIM patients with NYHA Class II heart failure. 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. The ACCLAIM trial demonstrated a 39% reduction (p=0.0003) in the risk of death and cardiovascular hospitalizations for the large pre-specified subgroup of 689 NYHA class II heart failure patients.
|SOURCE Vasogen Inc.|
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