Vasogen has provided an update on its two late-stage clinical programs -- the SIMPADICO and ACCLAIM trials. The double-blind, placebo-controlled pivotal Phase III trials are designed to support regulatory approval and commercialization of Vasogen's lead product, Celacade, in North America and Europe.
The SIMPADICO trial, which is designed to further investigate the use of Celacade to improve intermittent claudication, a debilitating symptom associated with peripheral arterial disease, completed enrollment of 550 patients at 50 centers in North America at the end of 2004. The primary endpoint of the SIMPADICO study is the change in maximum walking distance at six months. The study is also designed to investigate the impact of Celacade on additional endpoints, including peripheral arterial disease and cardiovascular-related events, and quality of life at six and 12 months.
The 2,400-patient pivotal phase III ACCLAIM trial is now approaching completion at 176 clinical centers in North America, Europe, and Israel. The ACCLAIM trial is designed to definitively assess the impact of Celacade on reducing the risk of death and cardiovascular hospitalization in patients with advanced chronic heart failure. ACCLAIM was designed to conclude when at least 701 patients sustained a primary endpoint event, defined as either a death or first cardiovascular hospitalization, and all patients had been in the study for a minimum of six months.