Vasogen announces full patient enrollment in its trial of Celacade in peripheral arterial disease

Nov 16 2004

Vasogen today announced that it has reached full enrollment in its 500-patient pivotal phase III SIMPADICO trial of Celacade (immune modulation therapy) for the treatment of peripheral arterial disease (PAD).

PAD is a serious condition resulting from atherosclerosis that causes insufficient blood flow to the lower extremities, impairing the ability to walk and carry out the normal activities of daily independent living. The disease is estimated to affect over seven million people in the United States alone, with related healthcare costs exceeding $10 billion annually.

"The SIMPADICO clinical trial investigators and their patients have clearly embraced Celacade as a potential new therapy for a disease that is vastly underserved," stated Dr. Jeffrey Olin, Professor of Medicine at the Mount Sinai School of Medicine, Director of Vascular Medicine at The Zena and Michael A. Wiener Cardiovascular Institute in New York, and Principal Investigator for the SIMPADICO trial. "SIMPADICO employed one of the most rigorous screening protocols ever used in a PAD trial assessing improvements in exercise tolerance. Our comprehensive screening protocol resulted in the screening of over 900 patients and is expected to be a key factor in determining the consistency and quality of the primary endpoint outcome, which we will reach in six months."

The SIMPADICO trial has enrolled 500 patients with symptomatic PAD and intermittent claudication (Fontaine stage II) at 50 clinical sites in the United States and Canada. SIMPADICO (Study of Immune Modulation Therapy in Peripheral Arterial Disease and Intermittent Claudication Outcomes) was designed by an independent steering committee of thought leaders in vascular medicine to investigate the impact of Celacade on improving the symptom of intermittent claudication (pain on walking) in PAD and to support regulatory approval and marketing in North America and Europe. The primary endpoint of SIMPADICO is the change in maximal treadmill walking distance after six months; a primary efficacy endpoint recognized by the FDA and other regulatory authorities for approving new treatments for symptomatic PAD. The primary endpoint of the SIMPADICO study is expected to be completed in the second quarter of 2005 and results will be made available following analysis of the data.

Peripheral arterial disease is a term used to denote impaired blood flow to the lower extremities resulting from atherosclerosis. It is now well established that inflammatory pathways are implicated in the development and progression of atherosclerosis and claudication, and known risk factors such as aging, obesity, smoking, lack of exercise, and diabetes contribute to the increasing incidence of PAD. The disease often leads to reduced mobility and a marked impairment in the ability to undertake the basic activities of daily independent living. It is estimated that in the United States alone, PAD affects over seven million people, with related healthcare costs exceeding $10 billion annually. The condition is associated with a high level of morbidity, and an estimated 30% of patients diagnosed with PAD will die within five years. Patients with PAD have a six-fold increase in risk of death from cardiovascular disease. In approximately 80,000 patients each year, the progression of PAD results in the need for amputation. Currently, there are limited effective pharmacological therapies available for the treatment of intermittent claudication, and there is a need for a more effective treatment option.