Vasogen News:
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FDA Grants Vasogen Approval To Proceed With U.S.
Clinical Trial
Tuesday, September 21, 1999, 9:08 AM EDT
Toronto, Ontario
Investor Relations
Trevor Burns, Vasogen Inc.
tel (905) 569-9065
Media contact
ORO Communications
tel (514) 426-1505 or (416) 484-8186
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.
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. |
