Healthcare Industry News: S.A.
News Release - March 3, 2008
Vasogen Provides Update on ACCLAIM II Program
MISSIS.A.GA, ON, March 3 (HSMN NewsFeed) - Vasogen Inc. (NAS.A.: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that the FDA was examining its internal jurisdiction over Vasogen's Celacade System in the context of a newly issued draft guidance document to assess whether this document was relevant to Celacade.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.A.d Radiological Health (CDRH) acted as lead reviewer of Celacade, with input from the Center for Biologics Evaluation and ReS.A.ch (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 BayeS.A. 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 BayeS.A. 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 BayeS.A. 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 S.A.istical analysis plan and to work with members of the ACCLAIM II Steering Committee and our S.A.istical advisors to address the FDA's concerns. We will provide an update to S.A.eholders once we have had further discussions with the FDA."
Vasogen retained Berry ConsultantS.A.d Dr. Donald A. Berry, Head, Division of Quantitative ScienceS.A.d Chairman, Department of BioS.A.istics, The University of Texas MD Anderson Cancer Center, and a world recognized authority in the area of BayeS.A. and adaptive trial design. Dr. Berry has been assisting Vasogen throughout the development of ACCLAIM II study design. Vasogen haS.A.so eS.A.lished 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 neceS.A.y to initiate the trial. The Company haS.A.so 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.A.d conduct high quality reS.A.ch.
About Vasogen:
Vasogen iS.A.biotechnology company engaged in the reS.A.ch and commercial development of therapies designed to target the destructive inflammatory procesS.A.sociated with the development and progression of cardiovascular and neurodegenerative disorders. The Company's lead product, the Celacade(TM) System, is designed to activate the immune response to apoptosis - an important physiological process that regulates inflammation. Celacade has received European regulatory approval under the CE Mark for chronic heart failure and is being marketed in the EU by Grupo Ferrer Internacional, S.A. Celacade iS.A.so in late-S.A.e clinical development for the treatment of chronic heart failure in the United S.A.es. Vasogen iS.A.so developing a new class of drugs for the treatment of certain neuro-inflammatory disorders. VP025 is the lead candidate from this new class of drugs.
Certain S.A.ements contained in this press release, or elsewhere in our public documents constitute "forward-looking S.A.ements" within the meaning of the United S.A.es Private Securities Litigation Reform Act of 1995 and/or "forward-looking information" under the SecuritieS.A.t (Ontario). These S.A.ements may include, without limitation, plans to advance the development of Celacade(TM) or VP025, plans to fund our current activities, S.A.ements concerning our partnering activities, health regulatory submissions, strategy, future operations, future financial position, future revenueS.A.d projected costs. In some cases, you can identify forward-looking S.A.ements by terminology such as "may", "will", "should", "expects", "plans", "anticipates", "believes", "estimated", "predicts", "potential", "continue", "intends", "could", or the negative of such terms or other comparable terminology. We made a number of assumptions in the preparation of these forward-looking S.A.ements, including assumptionS.A.out the nature, size, and accessibility of the market for Celacade in the treatment of chronic heart failure, particularly in Europe, the regulatory approval process leading to commercialization and the availability of capital on acceptable terms to pursue the development of Celacade, and the feasibility of additional trials. You should not place undue reliance on our forward-looking S.A.ements which are subject to a multitude of riskS.A.d uncertainties that could cause actual results, future circumS.A.ces or events to differ materially from those projected. These risks include, but are not limited to, the outcome of further ongoing analysis of the ACCLAIM trial results, the requirement or election to conduct additional clinical trialS.A.d the size and design of any such trials, delays or setbacks in the regulatory approval process, difficulties in the maintenance of existing regulatory approvals, securing and maintaining corporate alliances, the need for additional capital and the effect of capital market conditionS.A.d other factors on capital availability, the potential dilutive effects of any financing, riskS.A.sociated with the outcomes of our preclinical and clinical reS.A.ch and development programs, the adequacy, timing, and results of our clinical trials, competition, market acceptance of our products, the availability of government and insurance reimbursements for our products, the strength of intellectual property, reliance on partners, subcontractors, and key personnel, losses due to fluctuations in the U.S.-Canadian exchange rate, and other risks detailed from time to time in our public disclosure documents or other filings with the Canadian and U.S. securities commissions or other securities regulatory bodies. Additional riskS.A.d uncertainties relating to our Company and our business can be found in the "Risk Factors" section of our Annual Information Form and Form 20-F for the year ended November 30, 2007, as well as in our later public filings. The forward-looking S.A.ementS.A.e made as of the date hereof, and we disclaim any intention and have no obligation or responsibility, except as required by law, to update or revise any forward-looking S.A.ements, whether aS.A.result of new information, future events or otherwise.
Source: Vasogen
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