Vasogen Inc. (NASDAQ:VSGN)
Industry: Healthcare

Listed 29 Consecutive Market Days. On List as of 01/27/2006 Through 03/10/2006

Vasogen Inc. (Vasogen) develops and commercializes new treatments for cardiovascular, neurological and other chronic inflammatory diseases. The Company's lead product, the Celacade technology, is in the final stages of two pivotal phase III programs designed to support regulatory approval in North America and commercialization in North America and Europe. The 550-patient phase III SIMPADICO trial, which was closed out early, is a 50-center North American study designed to further investigate the use of its Celacade technology to improve intermittent claudication, a debilitating symptom associated with peripheral arterial disease. The 2,400-patient phase III ACCLAIM trial is a 176-center international study that is designed to further investigate the use of the Company's Celacade technology to reduce the risk of death and hospitalization in patients with advanced chronic heart failure. Vasogen is also developing a new class of drugs for the treatment of neuro-inflammatory disorders. VP025 is the lead product candidate from this new class of drugs. It has two wholly owned subsidiaries Vasogen, Corp. and Vasogen Ireland Limited. Celacade Peripheral Arterial Disease Program Vasogen is advancing a pivotal phase III, double blind, placebo-controlled clinical trial of the Celacade technology in patients with peripheral arterial disease. Vasogen's Study of Immune Modulation Therapy in Peripheral Arterial Disease and Intermittent Claudication Outcomes (SIMPADICO) trial is investigating the use of the Celacade technology to improve the symptom of intermittent claudication. The initiation of the Company's SIMPADICO trial was based on results from its double-blind, placebo-controlled phase II clinical trial conducted in 85 patients with moderate to severe PAD. The primary endpoint of the SIMPADICO trial is the change in maximal treadmill walking distance after six months compared to placebo, a primary efficacy endpoint recognized by the United States Food and Drug Administration (FDA) and other regulatory authorities for approving new products for the treatment of patients with peripheral arterial disease (PAD). Celacade Chronic Heart Failure Program Vasogen is advancing the pivotal phase III double blind, placebo-controlled Advanced Chronic Heart Failure CLinical Assessment of Immune Modulation Therapy (ACCLAIM) trial to further investigate the use of the Celacade technology to reduce the risk of death and cardiovascular hospitalization in patients with advanced chronic heart failure. The ACCLAIM trial completed the enrollment of patients in May 2005, with over 2,400 patients enrolled at 176 clinical centers in North America, Europe and Israel. ACCLAIM was designed to conclude when at least 701 patients sustained a primary endpoint event, defined as either death or first cardiovascular hospitalization, and all patients had been in the study for a minimum of six months. In November 2005, the trial reached the pre-specified objective of 701 primary endpoint events, and all patients had been in the study for a minimum of six months. The final patient assessment was completed in January 2006. The Company anticipates reporting the results of the ACCLAIM study, as well as its plans for presentation and publication of the data, during 2006. VP025 Drug Development Program Vasogen is developing a new class of drugs designed to interact with antigen presenting cells (APCs) to regulate cytokine levels and control inflammation. The new class of drugs is based on synthetic three-dimensional, phospholipid-based structures with specific groups of surface molecules that are designed to interact with APCs to modulate cytokine levels. In July 2005, the Company announced the successful completion of a Phase I clinical trial of VP025. This double-blind, placebocontrolled, dose-escalation trial examined the safety and tolerability of three doses of VP025 in 24 healthy volunteers. Multiple administrations of either low, mid, or high doses of VP025 were shown to be safe and well tolerated when compared to placebo, and no drug-related s

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