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 22, 2000, entitled: "Vasogen
Receives Health Canada Approval For Clinical Trial In Leukemia Patients"
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 15, 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 HEALTH CANADA APPROVAL
FOR CLINICAL TRIAL IN LEUKEMIA PATIENTS
Toronto, Ontario, (March 22, 2000) - Vasogen Inc. (TSE:VAS; AMEX:MEW) today
announced that it has received Health Canada approval to proceed with a clinical
trial in leukemia patients undergoing bone marrow transplantation. The trial is
designed to investigate the safety and efficacy of Vasogen's VAS981
cell-processing technology in preventing graft-versus-host disease (GvHD)--a
potentially life-threatening complication of bone marrow transplantation.
Treatments for leukemia often involve the use of powerful chemotherapeutic drugs
or radiotherapy. These treatments result in the destruction of bone marrow, the
site of production of immune system cells. The destroyed bone marrow is then
replaced by bone marrow from a donor that is matched as closely as possible to
that of the patient. GvHD is a potentially fatal complication of bone marrow
transplantation resulting from an immune response that occurs when T cells in
the donated bone marrow (graft), identify cells and tissues in the recipient's
body (host) as foreign and mount an inflammatory response against them. GvHD
causes symptoms related predominantly to the skin, bowel, and liver of the
recipient.
The VAS981 trial will be carried out at the Princess Margaret Hospital, under
the direction of Dr. Hans Messner, Director of the Bone Marrow Transplant
Program, with results expected in the second half of 2000. The Princess Margaret
Hospital, a teaching hospital of the University of Toronto and a member of the
University Health Network, has achieved an international reputation as a global
leader in the fight against cancer. The trial will initially enroll up to six
leukemia patients who require a life-saving bone marrow transplant. For these
cancer patients, the available donor bone marrow may not be perfectly matched to
their tissues, which puts them at increased risk of developing severe GvHD.
"Although drugs that suppress the immune system can help decrease the severity
of GvHD, it remains a major cause of death in cancer patients undergoing bone
marrow transplantation," said Dr. Messner. "A technology to address this serious
medical problem would make life-saving bone marrow transplants more effective
and may facilitate their use in patients with less than an ideal match."
Previously announced results from research conducted at the Division of Cancer
Biology Research, Sunnybrook Health Sciences Centre, University of Toronto,
under the direction of Dr. David Spaner, demonstrated that the treatment of
donor immune cells with VAS981 prior to transplantation prevented GvHD in
pre-clinical models. The effects of VAS981 on human immune cells that are
administered in bone marrow grafts and that cause GvHD have also been
investigated. The results demonstrate that VAS981-treated cells produced much
lower levels of the inflammatory cytokines that are associated with GvHD. The in
vitro changes seen in these laboratory studies on human cells closely mirrored
those seen in vivo in the pre-clinical models, where they were associated with a
dramatic reduction in GvHD.
Complications associated with GvHD cost health care systems in excess of $500
million annually and severely limit the number of donor bone marrow transplant
procedures that can be performed. Overcoming this problem would make it possible
to extend life-saving bone marrow transplantation to thousands more cancer
patients each year.
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.
