To: thewiz who wrote (173 ) 4/22/1999 11:17:00 AM From: Julian Read Replies (1) | Respond to of 377
STUDY DEMONSTRATES VASOCARE(TM) THERAPY REDUCES DEVELOPMENT OF ATHEROSCLEROSIS AND LOWERS CHOLESTEROL Researchers from the University of Toronto have announced results from pre-clinical studies showing that Vasogen's immune modulation therapy, VasoCare(TM), reduced the development of atherosclerosis by up to 75 percent and showed a significant cholesterol-lowering effect. The results were presented at the Experimental Biology Meeting of the Federation of American Societies of Experimental Biology (FASEB) in Washington, D.C. Atherosclerosis is the build-up of cholesterol-containing plaque within the blood vessel wall and is the major cause of cardiovascular disease, the leading cause of death and disability in developed countries. Approximately half of all patients with atherosclerosis also have elevated levels of blood lipids, such as cholesterol and triglycerides, which are considered to be major risk factors for the development of atherosclerosis. The market for cholesterol-lowering drug therapies aimed at treating this problem exceeds $5 billion annually in the US alone and is growing at more than 20 percent per year. The studies were performed in the LDL-receptor knockout [LDL-R(-/-)] mouse, an accepted model of human atherosclerosis, at St. Michael's Hospital, University of Toronto, Canada, under the direction of Dr. Duncan Stewart, Head of the Division of Cardiology. LDL-R(-/-) mice lack LDL cholesterol receptors and are specially bred to mimic the status of patients with an inherited type of high blood cholesterol, who are at a high risk of suffering from heart attack and stroke at an early age. LDL-R (-/-) mice rapidly develop severe atherosclerosis when fed a diet rich in cholesterol and fat. The results presented at FASEB showed that VasoCare(TM) therapy, administered at the mid-point of an eight-week high-fat diet, resulted in a significant reduction in the relative proportion of atherosclerotic plaque in the aorta, the main artery leading from the heart. The ratio of the atherosclerotic plaque area to the total area of the aorta was reduced from 0.16(0.1 in untreated animals, to 0.04(0.03 in animals receiving VasoCare(TM) therapy, (p<0.05) - a reduction of 75 percent. This marked reduction in development of atherosclerotic plaque was associated with highly significant reductions in both the total cholesterol (34% - p<0.00001) and triglyceride (51% - p<0.00001) levels in blood in VasoCare(tm)-treated compared to untreated animals. At the same time, there was no significant lowering of the blood levels of HDL, a type of cholesterol that has been shown to inhibit development of atherosclerosis. "Our results indicate that VasoCare(TM) therapy can significantly inhibit the development of atherosclerosis," said Dr. Stewart. "The next step is to repeat our research in a second animal species. If we have the same effect there, we would have a powerful therapy that is active across different species. We would then move to human studies, with a likely focus on coronary heart disease." Cardiovascular disease, including heart attack, strokes and peripheral vascular disease, affects millions of people in North America and Europe and costs health care systems in excess of $300 billion annually. In the US alone, 12 million people are affected by coronary heart disease, and a further four million suffer from stroke. These conditions cause more than 500,000 deaths annually in North America. Dr. Eldon Smith, Vasogen's Vice-President, Scientific Affairs, said: "These results, if confirmed in humans, would constitute a major breakthrough in the treatment and prevention of atherosclerosis. Given VasoCare(TM) therapy's excellent profile, it has the potential to offer an attractive therapeutic option to current cholesterol-lowering therapies." The Company's new research program in the area of atherosclerosis is augmenting data currently being generated in an ongoing placebo-controlled, clinical study in the United Kingdom in peripheral vascular disease - a serious form of vascular disease resulting from atherosclerosis that affects the arteries supplying blood to the legs. These patients have a risk of heart attack and stroke that is ten times greater than the general population. 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. VASOGEN INC. 2155 Dunwin Drive, Suite 10 Mississauga, ON, Canada L5L 4M1 tel (905) 569-2265 fax (905) 569-9231vasogen.com INVESTOR CONTACT Trevor Burns Investor Relations tel (905) 569-9065 e-mail investor@vasogen.com