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 January 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 January 19, 2000, titled: "Vasogen
Announces Plans 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: January 19, 2000
<PAGE>
Vasogen Inc. INVESTOR CONTACT
2155 Dunwin Drive, Suite 10 Trevor Burns
Mississauga, ON, Canada L5L 4M1 Investor Relations
tel (905) 569-2265 fax (905) 569-9231 tel (905) 569-9065
http://www.vasogen.com e-mail [email protected]
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FOR IMMEDIATE RELEASE
VASOGEN ANNOUNCES PLANS FOR U.S. CLINICAL TRIAL
IN PATIENTS WITH CONGESTIVE HEART FAILURE
Toronto, Ontario (January 19, 2000) -- Vasogen Inc. (TSE:VAS; AMEX:MEW) today
announced plans 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. The Company is currently completing regulatory submissions to
the FDA to commence the trial at two leading centers in the United States.
Nearly 5 million Americans suffer from CHF and its prevalence is increasing at
10 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.
Plans for the placebo-controlled clinical trial are underway at two leading U.S.
cardiovascular centres: 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.
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 experimentally to have a beneficial impact on many of these
pathological processes.
"The prospects for a novel non-pharmaceutical approach to the treatment of this
all too common and often fatal disorder are very exciting," said Dr. Guillermo
Torre, Baylor's Medical Director of the Heart Transplant Service. "The ability
of Vasogen's immune modulation therapy to beneficially regulate many of the
complex factors that lead to the relentless progression of this disease, while
avoiding the need to add to the already large number of drugs taken by these
patients, offers the potential for a major advance in cardiac care."
..... / cont'd
<PAGE>
While the introduction of treatment with beta blocking agents, angiotensin
converting enzyme (ACE) inhibitors, and aldosterone antagonists has
significantly reduced mortality in CHF, the condition remains the leading cause
of hospital admissions in patients over 65 years of age. In its most severe
form, CHF still results in a 50 percent one-year mortality rate.
"Addressing congestive heart failure represents an important extension of our
cardiovascular disease program," said Dr. Eldon Smith, Vasogen's Vice President
of Scientific Affairs. "We believe there is a significant opportunity to
demonstrate a beneficial effect in this life-threatening condition."
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.
