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Vasogen Inc -
Vasogen receives FDA approval to proceed with U.S. clinical trial
Vasogen Inc VAS
Shares issued 33,561,122 1999-09-20 close $3.4
Tuesday Sep 21 1999
Mr. David Elsley reports
Vasogen has received approval from the U.S. 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, Tex., one of the world's leading cardiovascular surgery centres.
"FDA clearance to proceed with clinical trials reflects the safety and therapeutic potential of VAS971," said David Elsley, Vasogen president and chief executive officer. "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. Preclinical 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, May 19 to 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 preclinical 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 per cent of the patients and serious disability in more than 40 per cent 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 uses 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 readministered 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 postoperative 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.
WARNING: The company relies upon litigation protection for "forward-looking" statements.
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