From rxpgnews.com
Antigen-presenting cells can be regulated to improve survival in neuro inflammatory disorders
By Akanksha,Pharmacology Correspondent
Jan 26, 2005, 13:22
VP025 is 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.
Vasogen Inc. has 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."
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.
"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."
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.
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Vasogen is a leader in the research and commercial development of technologies targeting the chronic inflammation underlying cardiovascular and neurological disease. Their lead product, the Celacade technology, is currently in two pivotal phase III clinical trials in life-threatening cardiovascular conditions with significant unmet needs. The 500-patient phase III SIMPADICO trial, which has completed patient enrolment, is designed to further investigate the use of our Celacade technology to improve intermittent claudication, a debilitating symptom associated with peripheral arterial disease. The 2000-patient phase III ACCLAIM trial, ongoing at more than 150 clinical centers in North America and Europe, is designed to further investigate the use of Celacade technology to reduce the risk of death and hospitalization in patients with advanced chronic heart failure. They are also developing a new class of drugs for the treatment of inflammation in the brain and central nervous system. VP025, the lead product candidate from this new class of drugs, is in development for the treatment of neuro-inflammatory disorders including Parkinson's disease and Alzheimer's disease.
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