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Vasogen Initiates Phase I Clinical Trial of VP025 - February 03, 2005 Vasogen Inc. (NASDAQ:VSGN; TSX:VAS), a leader in the research and commercial development of technologies targeting chronic inflammation underlying cardiovascular and neurological disease, today announced that it has initiated a phase I clinical trial of VP025, the lead drug candidate from its new class of drugs designed to target inflammation. VP025 is being developed to target the chronic inflammation within the central nervous system that is associated with a number of neurological diseases, including Alzheimer’s disease, Parkinson’s disease, and amyotrophic lateral sclerosis (Lou Gehrig’s disease). “The initiation of patient enrollment into our phase I trial of VP025 is a significant milestone for Vasogen, as it adds an exciting new product candidate to our clinical development pipeline,” commented David Elsley, President and CEO of Vasogen. “Our observations from a number of preclinical models that VP025 provided a neuro-protective effect in addition to demonstrating anti-inflammatory activity within the central nervous system, underpins our enthusiasm for this new drug candidate. We believe that this therapeutic profile offers significant potential for the treatment of neuro-inflammatory conditions, including Alzheimer’s disease and Parkinson’s disease.” VP025, the lead product from a new class of drugs designed to interact with antigen-presenting cells of the immune system to regulate tissue levels of cytokines and control inflammation, is being developed for neuro-inflammatory disorders. Data demonstrating the ability of VP025 to reduce levels of inflammation across the blood-brain barrier in a number of experimental models has been presented at major neurology conferences. In preclinical models, VP025 has been shown to improve biological correlates of memory function; reduce the established neural deficit associated with aging; and prevent detrimental effects of beta-amyloid, a major component of the plaques found in the brains of Alzheimer’s disease patients. VP025 has also been shown experimentally to delay disease onset and prolong survival in a model of Lou Gehrig’s disease; reduce movement abnormalities in a model of Parkinson’s disease; and reduce the level of activation of microglial cells – inflammatory cells specifically found in the central nervous system. The double-blind, placebo-controlled phase I clinical trial of VP025 will examine safety and tolerability of various doses of VP025 in up to 24 healthy volunteers. The trial is expected to be completed during the second quarter and, subject to successful outcomes, is expected to form the basis of an application to commence phase II clinical development in patients with neuro-inflammatory disorders. There are several neurological conditions associated with inflammation in the brain and central nervous system, including Alzheimer’s disease, Parkinson’s disease, and Lou Gehrig’s disease. Due to the prevalence, morbidity, and mortality associated with neuro-inflammatory diseases, they represent a significant medical, social, and financial burden. It is estimated that these neurological conditions affect more than five million people in North America and generate costs of care that exceed US$75 billion annually. About Vasogen |