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 September 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 September 21, 1999, titled:
"FDA Grants Vasogen Approval to Proceed With U.S. Clinical Trial"
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: September 22, 1999
<PAGE>
Vasogen Inc. Investor Relations
Trevor Burns, Vasogen Inc.
2155 Dunwin Drive, Suite 10 tel (905) 569-9065
Mississauga, ON, Canada L5L 4M1 Media contact
tel (905) 569-2265 fax (905) 569-9231 ORO Communications
http://www.vasogen.com tel (514) 426-1505
or (416) 484-8186
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FOR IMMEDIATE RELEASE
FDA GRANTS VASOGEN APPROVAL TO PROCEED WITH U.S. CLINICAL TRIAL
Toronto, Ontario (September 21, 1999) -- Vasogen Inc. (TSE: VAS; NASD OTC BB:
VSOGF) today announced that it has received approval from the US Food & Drug
Administration (FDA) to proceed with a controlled double-blind clinical trial to
assess the safety and effectiveness of its VAS971 immune modulation therapy in
protecting vital organs during cardiovascular surgery. The trial will be
conducted at the Baylor College of Medicine in Houston, Texas, one of the
world's leading cardiovascular surgery centers.
"FDA clearance to proceed with clinical trials reflects the safety and
therapeutic potential of VAS971", said David Elsley, Vasogen President & CEO.
"Rapidly moving a second product into clinical trials demonstrates our
determination to develop a series of immune modulation therapies for the global
marketplace".
The Baylor trial, to be conducted under an Investigational Device Exemption from
the FDA, will enroll 40 patients scheduled to undergo major vascular surgery for
repair of thoracic-abdominal aortic aneurysms (TAAs). An aneurysm forms in the
aorta, the main artery leading from the heart, when a portion of the aortic wall
becomes weakened and expands. Often, the aneurysm increases in size until it
poses a life-threatening risk of rupturing. During TAA repairs, surgeons clamp
the aorta, which carries oxygenated blood to vital organs such as the kidneys,
liver, and bowel, for up to one hour. This complete but temporary interruption
in blood flow followed by its re-establishment is the major cause of vital organ
damage, commonly referred to as ischemia/reperfusion (I/R) injury. I/R injury is
also the major cause of tissue damage in strokes and heart attacks.
Following I/R injury there is a marked increase in programmed cell death
(apoptosis) in the damaged tissue. Pre-clinical studies at the University of
Montreal have shown that, when administered prior to surgery, VAS971 protects a
number of vital organs from the damaging effects of I/R injury and results in a
significant reduction in the level of apoptotic cell death. These data were
presented at the 25th Annual Scientific Meeting of the American Society of
Transplant Surgeons, Chicago, USA, May 19-21, 1999 and form the basis for FDA
clearance to proceed with clinical trials.
"Surgeons are constantly looking for ways to improve outcomes, especially in
major cardiovascular surgery where complications can take a tremendous toll on
the patient," said Dr. Guillermo Torre, Medical Director, Heart Transplant
Service, Baylor College of Medicine and a principal investigator in the Vasogen
study. "The pre-clinical results with VAS971 are very impressive and suggest
that this product holds the potential to reduce complications associated with
ischemia/reperfusion injury and improve survival rates following cardiovascular
surgery."
Complication rates associated with TAA repair surgery are the highest of any
aneurysm repair, leading to death in 7% of the patients and serious disability
in more than 40% of cases. The Baylor trial has been designed to demonstrate the
effectiveness of VAS971 in protecting vital organs and tissues from the damaging
effects of ischemia/reperfusion injury during this procedure. Patients enrolled
in the study will receive a course of VAS971 therapy involving three, 30-minute
outpatient treatments administered during the two-week period leading up to
surgery. The therapy utilizes components derived from a sample of a patient's
own blood that has been modified by physicochemical processing in a proprietary
medical device technology. Following processing, the treated sample is
re-administered to the patient. VAS971 is designed to target the destructive
immune and inflammatory processes that occur in ischemia/reperfusion injury.
<PAGE>
Ischemia/reperfusion injury is associated with most forms of major vascular
surgery, including aortic aneurysm repair and coronary bypass graft surgery. It
leads to post-operative complications, prolonged recovery times and consequent
higher costs to health care systems, third-party insurers and managed care
organizations. With in-patient care forming the largest component of health care
costs, there is an increasing focus on the need to develop products that can
improve surgical outcomes and reduce length of stay in hospital. A treatment
with the ability to protect vital organs and tissues against
ischemia/reperfusion injury would meet cost-containment requirements and benefit
the hundreds of thousands of patients undergoing major vascular surgery each
year in North America and Europe. Complications associated with these procedures
cost health care systems in excess of $1 billion annually.
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.
