Copyright 2005 Canada NewsWire Ltd.
Canada NewsWire
January 24, 2005, Monday
SECTION: FINANCIAL NEWS
DISTRIBUTION: Attention Business, Financial, Science and Medical Editors
LENGTH: 1211 words
DATELINE: MISSISSAUGA, ON, Jan. 24
Vasogen Inc. (NASDAQ:VSGN; TSX:VAS),
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.