Press Release Oct 19:
isdnwire.com
Vasogen Inc. - Health Canada Grants Vasogen Approval To
Proceed With Clinical Trial In Psoriasis
Tuesday, October 19, 1999, 9:27 AM EDT
Toronto, Ontario
Vasogen Inc. (TSE: VAS; NASD OTC BB: VSOGF) today announced that
it has received approval from Health Canada to proceed with a
clinical trial to assess the safety and effectiveness of its
VAS972 immune modulation therapy in the treatment of psoriasis.
The trial will be conducted at the Sunnybrook Health Sciences
Centre, Toronto, Ontario, under the direction of Dr. Daniel
Sauder, Professor and Chief of Dermatology at the University of
Toronto.
Psoriasis is one of the most common dermatological diseases,
occurring in up to 2% of the population worldwide. In the United
States alone, between 150,000 and 250,000 new cases of psoriasis
occur annually. Costs in terms of treatment and care exceed US $3
billion annually.
The Sunnybrook trial, approved under an Application for
Investigational Testing from Canada's Medical Device Bureau, will
enroll up to 40 patients with moderate to severe psoriasis.
Psoriasis is a serious skin disorder characterized by
immune-related inflammation and excessive skin cell growth. It is
a lifelong condition with chronic recurrent exacerbations and
remissions that are emotionally and physically debilitating.
Powerful immunosuppressive drugs are currently used to treat
psoriasis. These drugs, while effective in the treatment of
psoriasis, have significant adverse side effects, including
kidney toxicity and increased incidence of malignancies.
"Psoriasis is such a distressing and disfiguring condition that
patients are prepared to use very aggressive therapies in an
effort to control their disease," said Dr. Daniel Sauder,
principal investigator of the Vasogen study. "The major problem
with current therapies for severe psoriasis is that they produce
significant adverse side effects and are expensive. In contrast,
VAS972 has an excellent safety profile and can be delivered very
cost-effectively. If the positive pre-clinical data translate
into successful clinical outcomes, VAS972 would represent a major
advance in the treatment of psoriasis."
Patients participating in the psoriasis trial will receive a
standard course of VAS972 therapy, comprising a series of
20-minute outpatient treatments. Each treatment involves the
withdrawal of a sample of a patient's blood, modification by
physicochemical processing in a proprietary medical device, and
the subsequent re-administration of the treated sample to the
patient. Vasogen's therapeutic approach has been shown
experimentally, and in patients with autoimmune disease, to
beneficially modify destructive immune processes which lead to
the damaging inflammation associated with a number of autoimmune
diseases.
"Moving a third product into clinical trials represents another
milestone for the Company," said David Elsley, Vasogen's
President and CEO. "HPB clearance for VAS972 brings us within
reach of our goal of having four products approved for clinical
development prior to year end."
Vasogen is developing proprietary immune modulation therapies to
advance the treatment of cardiovascular, autoimmune and related
inflammatory diseases. These therapies are designed to target
fundamental disease-causing events, providing safe, effective
treatment.
Statements contained in this press release, including those
pertaining to scientific and clinical research, commercialization
plans, strategic alliances, and intellectual property protection,
other than statements of historical fact, are forward-looking
statements subject to a number of uncertainties that could cause
actual results to differ materially from statements made |
