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 October 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 October 17, 2000, entitled:
"Vasogen Announces Positive Clinical Results in Psoriasis".
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: October 17, 2000
<PAGE>
Vasogen Inc.
INVESTOR CONTACT
2155 Dunwin Drive
Mississauga, ON, Canada L5L 4M1 Glenn Neumann
tel: (905) 569-2265 fax: (905) 569-9231 Investor Relations
www.vasogen.com (905) 569-9065
[email protected]
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FOR IMMEDIATE RELEASE
Vasogen Announces Positive Clinical Results in Psoriasis
Toronto, Ontario (October 17, 2000) -- Vasogen Inc. (TSE:VAS; AMEX:MEW),
developer of proprietary immune modulation therapies for the treatment of
autoimmune/inflammatory disease, today announced positive safety and efficacy
data from a randomized, double-blind placebo-controlled feasibility clinical
trial of its VAS972 therapy for the treatment of patients with moderate to
severe psoriasis. The study was conducted at the Sunnybrook Health Sciences
Centre, Toronto, under the direction of Dr. Daniel Sauder, Professor and Chief
of Dermatology at the University of Toronto.
The trial enrolled 20 patients with moderate to severe psoriasis, who received
two standard courses of either VAS972 therapy or placebo, each administered over
a 3-week period on an out-patient basis. Of the patients receiving VAS972
therapy, 70% reported symptomatic improvement (by patient global assessment,
PGA) by the end of their first course of therapy. Furthermore, using the PASI
(psoriasis area severity index) score, 50% of patients receiving VAS972
experienced a clinically significant benefit (greater than 40% improvement in
PASI score), and, of these, 80% had a greater than 50% improvement -- double
that seen in the placebo group. VAS972 was shown to be well tolerated and safe,
based on both laboratory findings and clinical monitoring of adverse side
effects.
"The prospects for VAS972 are very promising, both in terms of the therapy's
beneficial effects and its lack of significant adverse side effects as compared
to standard therapies for severe psoriasis that have significant toxicity," said
Dr. Daniel Sauder, principal investigator for the study. "Given the therapy's
high degree of safety, I am looking forward to the further clinical development
of VAS972 as an attractive therapeutic option for patients afflicted with this
debilitating disease."
"The positive outcome of this trial, the first controlled, double-blind clinical
study of VAS972 in psoriasis, marks another significant development milestone
for Vasogen," said Dr. Clive Ward-Able, Vasogen's Vice President of Research and
Development. "Now that we have demonstrated the clinical benefit of immune
modulation therapy in these patients, we will be proceeding with the design of
multi-centre clinical trials to advance VAS972 in the regulatory approvals
process."
Psoriasis is an autoimmune disease and one of the most common dermatological
conditions, occurring in up to 2% of the world's population. It is a serious
skin disorder characterized by immune-related inflammation and excessive skin
cell growth. Annually, in the United States alone, 150,000 to 260,000 new cases
of psoriasis are diagnosed and patient visits to physicians exceed 1.25 million.
Furthermore, the annual cost of psoriasis out-patient care in the United States
is estimated to range from US$1.6 billion to US$3.2 billion.
-more-
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page 2, October 17, 2000
Vasogen's VAS972 therapy is designed to target disease-causing processes in
psoriasis by beneficially modulating immune responses that lead to destructive
inflammation. In addition to psoriasis treatment, the Company is developing
immune modulation therapies for a number of other autoimmune and inflammatory
conditions, including peripheral vascular disease, graft-versus-host disease,
congestive heart failure, and ischemia/reperfusion injury.
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. The Toronto
Stock Exchange has not reviewed and does not accept responsibility for the
adequacy or the contents of this news release.
