Vasogen Inc. (VSGN)

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Vasogen Provides Update on ACCLAIM II Program
Monday March 3, 9:06 am ET

MISSISSAUGA, ON, March 3 /PRNewswire-FirstCall/ - Vasogen Inc. (NASDAQ:VSGN - News; TSX:VAS - News) today provided an update on ACCLAIM II, a clinical trial which is being planned to support an application for U.S. market approval of the Celacade(TM) System for the treatment of patients with New York Heart Association (NYHA) Class II heart failure.

The Company announced in December that the FDA was examining its internal jurisdiction over Vasogen's Celacade System in the context of a newly issued draft guidance document to assess whether this document was relevant to Celacade. Previously, the FDA's Center for Devices and Radiological Health (CDRH) acted as lead reviewer of Celacade, with input from the Center for Biologics Evaluation and Research (CBER). The FDA has confirmed that Celacade will remain regulated as a medical device; however, CBER will be the lead reviewer of the Celacade technology, with CDRH providing input. The transition process from CDRH to CBER is now complete.

As part of the transition, on February 29, CDRH communicated to the Company that they now disagree with the use of a Bayesian approach because of a concern with recruiting a heterogeneous study population between ACCLAIM and ACCLAIM II. This is contrary to the FDA's original communication to Vasogen recommending a Bayesian study design, and, as part of its ongoing informal dialogue, the Company plans to provide the FDA with its position regarding the ACCLAIM II study population.

"The FDA's comments with respect to utilizing a Bayesian approach for the design of ACCLAIM II are surprising," commented Chris Waddick, President and CEO of Vasogen. "Our immediate focus will be to engage in discussions with the FDA to clarify their position on the proposed ACCLAIM II study protocol and statistical analysis plan and to work with members of the ACCLAIM II Steering Committee and our statistical advisors to address the FDA's concerns. We will provide an update to shareholders once we have had further discussions with the FDA."

Vasogen retained Berry Consultants and Dr. Donald A. Berry, Head, Division of Quantitative Sciences and Chairman, Department of Biostatistics, The University of Texas MD Anderson Cancer Center, and a world recognized authority in the area of Bayesian and adaptive trial design. Dr. Berry has been assisting Vasogen throughout the development of ACCLAIM II study design. Vasogen has also established the ACCLAIM II 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, appointed Chairs for the Data and Safety Monitoring Board (DSMB) and Central Endpoint Committee (CEC), and has drafted the key trial documents necessary to initiate the trial. The Company has also selected a CRO and has identified and received commitments from U.S.-based clinical sites to participate in the study. The majority of these sites participated in the first ACCLAIM trial and were selected on the basis of their ability to quickly recruit patients and conduct high quality research.