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 1999
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 19, 1999, titled: "Health
Canada Grants Vasogen Approval to Proceed with Clinical Trial 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 19, 1999
<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
HEALTH CANADA GRANTS VASOGEN APPROVAL
TO PROCEED WITH CLINICAL TRIAL IN PSORIASIS
Toronto, Ontario (October 19, 1999) 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 Canadas 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 patients blood, modification
by physicochemical processing in a proprietary medical device, and the
subsequent re-administration of the treated sample to the patient. Vasogens
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, Vasogens 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.
