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 November 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 November 3, 1999, titled: "Vasogen's
VasoCareTM Therapy Improves Blood Flow in Patients with Peripheral Vascular
Disease"
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: November 3, 1999
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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'S VASOCARE(TM) THERAPY IMPROVES BLOOD FLOW
IN PATIENTS WITH PERIPHERAL VASCULAR DISEASE
TORONTO, Ontario, (November 3rd, 1999) -- Vasogen Inc. (TSE:VAS; NASD OTC
BB:VSOGF) is pleased to announce the results of a placebo-controlled
double-blind clinical trial of its VasoCare(TM) therapy for the treatment and
prevention of atherosclerosis - the major cause of heart disease, strokes, and
peripheral vascular disease. The trial showed a significant improvement in the
rate of recovery of both skin blood flow and tissue oxygen levels following
ischemia, indicative of improved functioning of the blood vessels, in patients
with advanced peripheral vascular disease (PVD).
PVD is a serious form of cardiovascular disease resulting from atherosclerosis
(hardening of the arteries) that affects the arteries supplying blood to the
legs. In addition to having reduced blood flow to the lower limbs as a result of
atherosclerosis of the large arteries, patients with advanced PVD also have
generalized impairment of the microcirculation, which provides vital oxygen and
nutrition to tissues, including the skin. This is believed to result from
dysfunction of the endothelium (the cellular lining of blood vessels that
regulates blood flow and inhibits clotting).
In this study, conducted at the University Hospital, Lund, Sweden, under the
direction of Professor Lars Edvinsson, Department of Internal Medicine, changes
in the recovery rate of skin blood flow and oxygen tension following total
temporary occlusion of blood flow were measured in the extremities of patients
with advanced PVD. Eighteen patients were randomly assigned to one of two
groups: one group received two courses of VasoCare(TM) therapy over a nine-week
period, and a control group received two courses of a placebo treatment.
In patients receiving VasoCare(TM) therapy, improvement in the rate of recovery
of skin blood flow was noted as early as six weeks after the initiation of
therapy. At 18 weeks, the rate of recovery of skin blood flow was significantly
faster in the VasoCare(TM) group when compared to baseline (recovery time 27% of
baseline, p<0.05, paired t-test), whereas in the control group there was no
significant change. Recovery of skin oxygen content was also significantly
faster in the VasoCare(TM) group at 18 weeks (p<0.03, paired t-test). Despite
the limited number of patients enrolled in the study (n=9 in each group),
additional analysis, using repeated measures ANOVA, revealed a strong
statistical trend towards improvement in skin blood flow responses throughout
the post-treatment period in the VasoCare(TM) group when compared to the control
group (one-sided p value = 0.065).
Taken together, the Lund results provide evidence that VasoCare(TM) therapy
improves the microcirculation in patients with atherosclerosis and suggest an
improvement in endothelial function. Interventions that improve endothelial
function have been shown to reduce serious events, such as heart attack and
stroke, in patients suffering from atherosclerosis.
"VasoCare(TM) therapy provided a surprisingly long-lasting improvement in
responses of skin blood flow in patients with advanced PVD," said Dr. Edvinsson.
"Impaired skin blood flow can lead to tissue breakdown and the formation of slow
healing ulcers, which puts patients with advanced PVD at increased risk for
amputation. A therapy with the ability to improve skin blood flow would minimize
these costly and debilitating problems that accompany progression of the
disease."
<PAGE>
In addition to ongoing and planned clinical research in the area of
cardiovascular disease, the Company's pre-clinical research program is
investigating the impact of VasoCare(TM) therapy on the immune-mediated
inflammatory component of atherosclerosis. Pre-clinical research at the
University of Toronto has demonstrated that VasoCare(TM) therapy reduces the
progression of atherosclerosis by up to 75%. The University of Toronto
researchers are now investigating the effect of VasoCare(TM) therapy on
atherosclerosis in additional model systems and further investigating the
therapy's anti-inflammatory mechanisms.
"The findings of the Lund study represent an important milestone," said Dr.
Eldon Smith, Vasogen's Vice President of Scientific Affairs. "By providing
evidence of a favourable effect on endothelial function, this study represents
the first crucial link between pre-clinical models, where VasoCare(TM) therapy
has shown a marked impact on atherosclerosis, and patients with the disease."
Currently, more than 5 million people in North America and Europe have
symptomatic PVD - a number that is increasing as the population ages. PVD
patients have a risk of heart attack and stroke that is up to ten times greater
than the general population. Health care costs resulting from PVD exceed $10
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.
