Vasogen Inc.
2155 Dunwin Drive, Suite 10
Mississauga, ON, Canada L5L 4M1
tel: (905) 569-2265 fax: (905) 569-9231
vasogen.com
INVESTOR CONTACT
Trevor Burns
Investor Relations
tel: (905) 569-9065
e-mail: investor@vasogen.com
FOR IMMEDIATE RELEASE
VASOGEN RECEIVES FDA APPROVAL FOR U.S. CLINICAL TRIAL
IN PATIENTS WITH CONGESTIVE HEART FAILURE
Toronto, Ontario, (March 9, 2000) - Vasogen Inc. (TSE:VAS; AMEX:MEW) today
announced that it has received U.S. Food and Drug Administration (FDA)
approval to proceed with a two-center clinical trial of its immune
modulation therapy, VAS991, in patients with congestive heart failure (CHF).
CHF is a progressive and often fatal cardiac condition affecting millions of
people in North America.
Nearly five million Americans suffer from CHF and its prevalence is
increasing at ten percent per year, primarily due to the aging population,
as well as improved long-term survival in heart disease patients. CHF
occurs when the pumping function of the heart is insufficient to meet the
body's demand for oxygen and other nutrients. With prolonged inadequate
blood supply to vital organs and voluntary muscles, a number of compensatory
mechanisms develop, initially leading to salt and water retention, worsening
heart function, and eventually symptoms of shortness of breath, fatigue, and
swelling of the legs. The condition is usually progressive, becomes
irreversible, and ultimately results in death.
The placebo-controlled clinical trial, which will be conducted under an
Investigational Device Exemption from the FDA, will enroll 90 patients
diagnosed with chronic congestive heart failure. Enrollment for the trial,
planned at two leading U.S. cardiovascular centers, The Cleveland Clinic
Foundation, under the direction of Dr. James Young, Medical Director,
Kaufman Center for Heart Failure, and Baylor College of Medicine, under the
direction of Dr. Guillermo Torre, Medical Director, Heart Transplant
Service, is expected to commence next month.
"VAS991 represents an important extension of our cardiovascular disease
program," said Dr. Eldon Smith, Vasogen's Vice President of Scientific
Affairs. "As a non-pharmaceutical approach to the treatment of CHF, VAS991
offers the potential to beneficially impact the progression of this disease
without increasing the large number of drugs taken by these patients."
CHF is now recognized to be a systemic disorder characterized by excessive
sympathetic nervous system activity, generalized dysfunction of the blood
flow-controlling endothelial cells which line blood vessels, inflammation
secondary to immune activation of the Th1 cell type, and an increased death
rate of heart muscle cells. Vasogen's immune modulation therapy, which
involves the withdrawal of a sample of a patient's blood, modification of
the components within the sample, and administration of the modified sample
to the patient, has been shown in pre-clinical and clinical studies to have
a beneficial impact on many of these pathological processes.
In addition to VAS991, the Company currently has clinical trials underway
for VasoCare(tm) therapy for the treatment of atherosclerotic peripheral
vascular disease, VAS971 for the prevention of ischemia/reperfusion injury
during major vascular surgery, and VAS972 for the treatment of psoriasis.
Vasogen is focused on developing 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.
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