FORM 6 - K
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
REPORT OF FOREIGN PRIVATE ISSUER
Pursuant to Rule 13a-16 or 15d-16 of
The Securities Exchange Act of 1934
For the month of March 2000
Commission File Number 0-29350
VASOGEN INC.
(Translation of Registrant's name into English)
2155 Dunwin Drive, Suite 10, Mississauga, Ontario, L5L 4M1
(Address of principal executive offices)
(Indicate by check mark whether the registrant files or will file annual reports
under cover Form 20 - F or Form 40 - F.)
Form 20 - F [ X ] Form 40 - F [ ]
(Indicate by check mark whether the registrant by furnishing the information
contained in this Form is also thereby furnishing the information to the
Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of
1934.)
Yes [ ] No [ X ]
This Form 6-K consists of:
A press release issued by Vasogen Inc. on March 9, 2000, entitled: "Vasogen
receives FDA approval for U.S. Clinical Trial in Patients with Congestive Heart
Failure"
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf by the
undersigned, thereunto duly authorized.
VASOGEN INC.
By /S/Christopher Waddick
----------------------
(Name: Christopher Waddick)
(Title: Vice-President, Finance & CFO)
Date: March 9, 2000
<PAGE>
Vasogen Inc.
INVESTOR CONTACT
2155 Dunwin Drive, Suite 10
Mississauga, ON, Canada L5L 4M1 Trevor Burns
tel: (905) 569-2265 fax: (905) 569-9231 Investor Relations
http://www.vasogen.com tel: (905) 569-9065
e-mail: [email protected]
- --------------------------------------------------------------------------------
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.
