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Phase II Dosing Trial Initiated for Alprostadil in Limb Ischemia
The open-label multi-center study of Liprostin, a liposomal formulation of the prostaglandin E1(a) (PGE1(a)) infused intravenously, will include approximately 100 patients from 8 to 10 sites in Europe and Mexico. The study is designed to measure outcomes based on different dose ranges and treatment regimens over a six-week period of therapy. The study's primary endpoint is improvement in Maximum Walking Distance from baseline. Secondary endpoints include Pain Free Walking Distance, Resting Pain, Ankle-Brachial Index, NSS/NIS survey and Quality of Life assessments.
Critical Limb Ischemia (CLI) is a severe blockage of the arteries that impairs blood flow to the hands, legs and lower extremities, resulting in insufficient levels of oxygen in the affected areas. While CLI is often caused by an acute condition, such as a blood clot, more often it is caused by a chronic condition, such as Peripheral Arterial Disease (PAD). An estimated 8.4 million Americans have peripheral arterial disease and 4.1 million have intermittent claudication. Risk factors for PAD are similar to those for ischemic heart disease and include atherosclerosis, hypertension, hypercholesterolemia, cigarette smoking, cardiovascular disease and diabetes.
Many PAD patients experience CLI and intermittent claudication, which is leg pain or cramping. The pain can be brought on by exercise or experienced at rest. It is often localized to the calf but can also be present in the buttocks or thighs. Advanced cases can lead to pain at rest, loss of tissue, gangrene and other severe symptoms that can require extremely aggressive therapy, including surgery and amputation.
Dr. Diane Dottavio, Endovasc's vice president of research and development, commented, "This trial marks another important step in the development of Liprostin. Our hope is that Liprostin will become an important therapeutic option for physicians worldwide for the treatment of this painful and potentially life-threatening disease."
Dr. Fred Lowrey of Pharm-Olam International's Houston office will be directing the multinational study. "We are looking for the optimum dosing regimen to be used with Liprostin," said Dr. Lowrey. "We expect to have preliminary data to report by the end of the year, and will present final data at the American College of Cardiology scientific session in March 2004."