Vasogen Inc. INVESTOR CONTACT
2155 Dunwin Drive Glenn Neumann
Mississauga, ON, Canada L5L 4M1 Investor Relations
tel: (905) 569-2265 fax: (905) 569-9231 (905) 569-9065
www.vasogen.com [email protected]
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FOR IMMEDIATE RELEASE
Vasogen Announces Positive Results from VasoCare(TM) Clinical Trial in
Peripheral Vascular Disease
- Primary Endpoint Achieves Statistical Significance -
Toronto, Ontario (November 29, 2000) -- Vasogen Inc. (TSE:VAS; AMEX:MEW), a
developer of immune modulation therapies for the treatment of cardiovascular,
autoimmune and other inflammatory diseases, today announced positive results
from a clinical trial of VasoCare(TM) therapy in patients with peripheral
vascular disease (PVD). The randomized, double-blind, placebo-controlled
clinical trial, completed in 81 patients at two centres in the United Kingdom,
achieved its primary endpoint. Using an internationally recognized measure of
therapeutic efficacy in PVD, the study showed that significantly more patients
receiving VasoCare(TM) therapy had a greater than 50% increase in their walking
distances compared to placebo. In addition to enabling patients to walk further
before the onset of pain, VasoCare(TM) therapy was shown to be long lasting,
well tolerated, and free of significant adverse side effects.
"These clinically significant results compare very favourably with the current
therapies for PVD, underpinning our commitment to making VasoCare(TM) therapy
the treatment of choice for this debilitating condition," said Dr. Eldon Smith,
Vasogen's Vice President of Scientific Affairs. "The successful completion of
this study also validates our plans to develop VasoCare(TM) for broader
indications in which atherosclerosis plays a major role."
Peripheral vascular disease, which is characterized by reduced blood flow to the
lower extremities due to atherosclerosis, affects more than 12 million people in
North America and Europe, with approximately 600,000 newly diagnosed cases each
year. PVD usually presents as intermittent claudication, which is characterized
by pain, cramps, or muscle ache in the legs upon walking. Intermittent
claudication leads to reduced mobility and a marked impairment in a person's
ability to undertake the basic activities of daily independent living. Symptoms
of PVD are also recognized as a warning sign of systemic atherosclerosis, as PVD
patients have a threefold increase in the risk of heart attack and stroke
relative to that of the general population. As PVD progresses, it may lead to
pain even at rest. An estimated one in four PVD patients requires expensive
surgical intervention and, in more than 200,000 advanced cases each year, there
is a need to amputate the affected limb. Health expenditures resulting from PVD
are now estimated to exceed $12 billion annually in the United States alone.
The VasoCare(TM) trial was conducted at two leading U.K. cardiovascular centres:
the University of Dundee, Scotland, under the direction of Dr. Jill J. F. Belch,
Professor of Vascular Medicine, and at the University of Bristol, under the
direction of Dr. Roger Baird, Senior Vascular Surgeon, Directorate of Surgery.
The trial was designed to investigate the impact of VasoCare(TM) therapy on
patients' ability to walk free of claudication pain - a widely recognized
measure of therapeutic efficacy in PVD. The impact of intermittent claudication
on patients' mobility is measured both in terms of the distance a patient can
walk without pain (initial claudication distance, ICD) and the maximum distance
a patient can walk (absolute claudication distance, ACD).
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page 2, November 29, 2000
The 81 patients participating in the trial were stratified as having either
moderate claudication (ACD of more than 100 but less than 300 metres - 12
patients) or severe claudication (ACD of 20 to 100 metres - 69 patients).
Depending on their response to treatment, patients received two, three, or four
courses of treatment - either VasoCare(TM) therapy or placebo. All patients were
assessed prior to receiving any treatment (baseline) and at three weeks and nine
weeks following their last treatment. A follow-up assessment was also conducted
at 24 weeks from baseline. Patients were assessed using a standard treadmill
test in which changes in both ICD and ACD were measured. Therapy was
discontinued upon achievement of a positive response to treatment, defined as at
least a 50% improvement in ICD over baseline.
The primary endpoint of the study was met, with significantly more patients
receiving VasoCare(TM) therapy having a greater than 50% increase in their
pain-free walking distance (ICD) compared to placebo, at 24 weeks. Of patients
receiving VasoCare(TM) therapy, 67% achieved a greater than 50% improvement in
ICD at 24 weeks, compared to only 42% in the placebo group (p=0.047). Sub-group
analysis of the 69 severe claudication patients at nine weeks post-treatment
showed that 56.3% of VasoCare(TM)-treated patients had a greater than 50%
improvement in ICD compared to only 29.7% of the placebo group (p=0.031). This
result indicates that the effect of VasoCare(TM) therapy is of prolonged
duration and that the therapy is beneficial to those patients with the most
severe claudication, who suffer the greatest loss of mobility.
"We are pleased with the outcome of this clinical trial," said Dr. Jill Belch,
Professor of Vascular Medicine, University of Dundee and a principal
investigator for the study. "The improvements seen in these patients as measured
by increases in both pain-free and maximal walking distance reflect a clinically
significant effect of VasoCare(TM) therapy. Furthermore, VasoCare(TM) therapy
was shown to be well tolerated and, unlike existing treatments for claudication
pain, provided a medium- to long-term therapeutic benefit. These findings offer
the potential for a significant advance in the treatment of this debilitating
disease."
"Our efforts in the treatment of peripheral vascular disease have been limited
by the lack of effective pharmaceuticals and the need, in serious cases, to
resort to surgical intervention," said Dr. Roger Baird, Senior Vascular Surgeon
at the University of Bristol and a principal investigator for the study. "With
these exciting clinical results, we now have an attractive therapeutic option to
improve the functional capacity of PVD patients."
Examination of secondary endpoints in the severe claudication sub-group at nine
weeks post-treatment indicated a substantial increase in both the median
pain-free walking distance (ICD) and the median maximum walking distance (ACD).
The VasoCare(TM)-treated patients showed a significant increase in their median
ICD of 102% compared to the placebo group, which showed an increase of only 42%
(p=0.034). For median ACD, the VasoCare(TM)-treated patients showed an increase
of 57% compared to only 25% in the placebo group, a near significant difference
(p=0.06).
The magnitude of the beneficial effect of VasoCare(TM) therapy was also
illustrated by the increase in patients' average maximum walking distance (ACD)
at nine weeks post-treatment, another secondary endpoint in the severe
sub-group. The VasoCare(TM) group increased their average ACD from 65 metres at
baseline to 140 metres at nine weeks post-treatment, an improvement of 75
metres. This was almost double that seen in the placebo group where the average
increase was only 40 metres.
"To healthy people, the ability to walk 140 meters may not seem that important,"
remarked Dr. Clive Ward-Able, Vasogen's Vice President of Research &
Development, "but to patients with intermittent claudication, it can mean the
difference between being housebound and being able to shop for groceries."
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page 3, November 29, 2000
The trial also examined the impact of VasoCare(TM) therapy on the ratio of blood
pressure measured in the ankle to that in the arm (ankle brachial pressure
index, ABPI). When blood vessels to the legs become narrowed by atherosclerotic
plaque, blood flow to the legs is reduced, the arterial pressure in the legs is
decreased, and the ABPI is lowered. The degree of reduction of ABPI is
recognized to reflect the severity of PVD. In the VasoCare(TM)-treated group of
patients, the ABPI increased significantly over the course of the trial (within
group analysis of all limbs, p=0.001) compared to baseline, whereas there was no
significant change in the placebo group (within group analysis of all limbs,
p=0.155).
Peripheral vascular disease affects more than 12 million people in North America
and Europe with approximately 600,000 new diagnoses annually. Symptoms of PVD
are also recognized as a warning sign of systemic atherosclerosis, as PVD
patients have a threefold increase in the risk of heart attack and stroke
relative to that of the general population. Obesity, smoking, lack of exercise,
diabetes, and an aging population are all associated with the increasing
incidence of the disease. Health expenditures resulting from PVD are now
estimated to exceed $12 billion annually in the United States alone.
Vasogen's proprietary VasoCare(TM) therapy has been developed to target immune
processes that lead to inflammatory damage to the lining of blood vessels. These
destructive processes are implicated in blood vessel dysfunction, as well as the
initiation and progression of atherosclerosis - the major underlying cause of
heart disease, stroke, and peripheral vascular disease. In addition to
VasoCare(TM) therapy for the treatment of peripheral vascular disease, the
Company is developing immune modulation therapies for a number of additional
autoimmune and inflammatory conditions, including psoriasis, 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.
