MISSISSAUGA, ON, March 3 /PRNewswire-FirstCall/ - Vasogen Inc. (NASDAQ:VSGN; TSX:VAS) 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that the FDA was examining its internal jurisdiction over Vasogen's Celacade System in the context of a newly issued draft guidance document to assess whether this document was relevant to Celacade.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 ACCL
|SOURCE Vasogen Inc.|
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