To: caly who wrote (284 ) 1/24/2005 10:36:39 AM From: caly Read Replies (1) | Respond to of 377 Vasogen Receives Approval to Advance New Drug for Neuro-inflammatory Disease into Phase I Clinical Development Monday January 24, 8:43 am ET MISSISSAUGA, ON, Jan. 24 /PRNewswire-FirstCall/ - Vasogen Inc. (NASDAQ:VSGN - News; TSX:VAS - News), focused on the research and commercial development of technologies targeting chronic inflammation underlying cardiovascular and neurological disease, today announced that it has received regulatory approval from Health Canada to commence 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 brain and 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). "VP025 has the potential to provide a new way to target chronic inflammation in the brain and we are pleased with this earlier-than-expected regulatory approval to move this drug into clinical development," commented David Elsley, President and CEO of Vasogen. "With two pivotal phase III trials of our Celacade technology in chronic heart failure and peripheral arterial disease expected to be completed this year, VP025 represents a new area of development for Vasogen - targeting neuro-inflammatory conditions that have significant unmet medical needs." 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 have recently 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, and reduced movement abnormalities in a model of Parkinson's disease. "One common theme observed in our research has been a reduction in the level of activation of microglial cells - inflammatory cells specifically found within the central nervous system - following VP025 administration," commented Dr. Anthony Bolton, Vasogen's Chief Scientific Officer. "The observed changes in inflammatory responses and evidence of a neuro-protective effect have been consistent across different preclinical models of disease, providing evidence of a common pathway for the therapeutic effect of VP025." The double-blind, placebo-controlled phase I clinical trial of VP025 will examine safety and tolerability of increased doses 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.