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The teleconference with the FDA follows an announcement by the Company onMarch 3rd, stating that the FDA disagrees with the use of a Bayesian approachfor the planned ACCLAIM II study. This is contrary to the FDA's originalcommunication to Vasogen recommending a Bayesian study design.
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"Dr. Donald Berry, an expert in Bayesian trial design, and Dr. JamesYoung, a leading heart failure specialist with extensive expertise in thedesign and conduct of clinical trials in heart failure, joined our internalteam to help clarify and address the issues raised by the agency," commentedChris Waddick, President and CEO of Vasogen. "Having discussed with the FDAtheir concerns, we are now preparing a written response to the FDA's commentsand would expect to submit this to the agency during the next week - we willcontinue to update shareholders as appropriate."
Dr. Donald A. Berry, Head, Division of Quantitative Sciences and Chairman,Department of Biostatistics, The University of Texas MD Anderson CancerCenter, and a world recognized authority in the area of Bayesian and adaptivetrial design has been assisting Vasogen throughout the development of ACCLAIMII study design. Dr. James B. Young, Chairman, Division of Medicine at theCleveland Clinic Foundation and Medical Director, Kaufman Center for HeartFailure is Chairman of the ACCLAIM II Steering Committee. Dr. Young, who hasplayed a leading role in numerous multi-center clinical trials focusing onheart failure and transplantation, led Vasogen's 2,400-patient ACCLAIM studywhich was completed last year and demonstrated a 39% reduction (p=0.0003) inthe risk of death or cardiovascular hospitalizations for the large pre-definedsubgroup of 689 patients with NYHA class II heart failure.
About Vasogen:
Vasogen is a biotechnology company engaged in the research and commercialdevelopment of therapies designed to target the destructive inflammatoryprocess associated with the development and progression of cardiovascular andneurodegenerative disorders. The Company's lead product, the Celacade(TM)System, is designed to activate the immune response to apoptosis - animportant physiological process that regulates inflammation. Celacade hasreceived European regulatory approval under the CE Mark for chronic heartfailure and is being marketed in the EU by Grupo Ferrer Internacional, S.A.Celacade is also in late-stage clinical development for the treatment ofchronic heart failure in the United States. Vasogen is also developing a newclass of drugs for the treatment of certain neuro-inflammatory disorders.VP025 is the lead candidate from this new class of drugs.
Certain statements contained in this press release, or elsewhere in ourpublic documents constitute "forward-looking statements" within the meaning ofthe United States Private Securities Litigation Reform Act of 1995 and/or"forward-looking information" under the Securities Act (Ontario). Thesestatements may include, without limitation, plans to advance the developmentof Celacade(TM) or VP025, plans to fund our current activities, statementsconcerning our partnering activities, health regulatory submissions, strategy,future operations, future financial position, future revenues and projectedcosts. In some cases, you can identify forward-looking statements byterminology such as "may", "will", "should", "expects", "plans","anticipates", "believes", "estimated", "predict
