|
|
|
|
|
Update on Vasogen’s ACCLAIM Trial Presented Today at the Heart Failure Society of America Meeting Toronto, Ontario - September 21, 2005 Vasogen Inc. (NASDAQ:VSGN; TSX:VAS), announced that during a satellite symposium held today at the 9th Annual Scientific Meeting of the Heart Failure Society of America in Boca Raton, Florida, Guillermo Torre-Amione, MD, PhD, Medical Director, The Methodist DeBakey Heart Center, presented preliminary baseline patient characteristics from the phase III ACCLAIM trial of Celacade™ in chronic heart failure (HF). The symposium also featured an overview of the role of inflammation in heart failure by Douglas Mann, MD, Professor of Medicine, Molecular Physiology, and Biophysics and Chief, Section of Cardiology, at Baylor College of Medicine and Director, Winters Center for Heart Failure Research. The session, entitled “Immunomodulatory Therapy for the Treatment of Heart Failure: An Update”, was chaired by James Young, MD, Chairman of the Division of Medicine and Professor of Medicine at the Cleveland Clinic and Global Principal Investigator for the ACCLAIM trial. Dr. Mann’s presentation covered the experimental and clinical rationale for targeting inflammation in HF. During the presentation, Dr. Mann reviewed previous trials evaluating anti-TNF therapies for HF and offered insights as to why these approaches did not prove successful, including the redundancy of the immune system and the involvement of multiple inflammatory cytokines in cardiac inflammation. Dr. Mann also reaffirmed that chronic inflammation remains unaddressed by available therapies for heart failure and is a key therapeutic target for new treatment modalities. Dr. Torre-Amione presented an overview of the approaches to the modulation of inflammation in chronic HF, discussed the role for Vasogen’s Celacade™ technology in this condition, and provided an update on the phase III ACCLAIM trial. The preliminary blinded baseline characteristics from ACCLAIM included left ventricular ejection fraction (LVEF), a key measure for determining the severity of disease based on the extent of a patient’s heart muscle impairment. The baseline characteristics show that patients enrolled in ACCLAIM have a mean LVEF of approximately 22.7%, which is virtually identical to the mean LVEF observed for patients in Vasogen’s phase II study. Additional baseline characteristics for patients in ACCLAIM show that the mean age is 64 years, 80% are male, and 68% have ischemic heart disease, which are also consistent with the patient population in the previous phase II study. Dr. Torre-Amione also reported that the fully enrolled ACCLAIM trial remains on schedule for completion in late 2005, with results to be made available following data-base lock and data analysis. “The role of inflammation in chronic heart failure continues to gain acceptance, and the promise of new anti-inflammatory strategies, such as Celacade, for treating this condition continue to garner considerable interest in the cardiology community,” commented Dr. Torre-Amione. “We are also pleased to find that the preliminary baseline characteristics of the patients enrolled in ACCLAIM are remarkably consistent with those of patients in our previous phase II trial, which bodes well for our ability to demonstrate the impact of Celacade on mortality and morbidity in chronic heart failure.” The double-blind, placebo-controlled ACCLAIM trial has enrolled over 2,400 patients at 176 clinical sites in North America, Europe, and Israel. An independent steering committee comprised of thought leaders in heart failure from around the world designed ACCLAIM to investigate the impact of Vasogen’s Celacade technology on reducing the risk of death and cardiovascular hospitalization in patients with advanced chronic heart failure. The design of the ACCLAIM trial was based on the findings from Vasogen’s phase II study in advanced chronic heart failure, which demonstrated a significant reduction in the risk of death and hospitalizations for patients who received Celacade™ versus placebo. ACCLAIM is an event-driven study that will reach its primary endpoint when 701 patients have experienced a primary endpoint event, defined as either death or first cardiovascular hospitalization, and all patients enrolled in the study have been treated for at least 6 months. The symposium was made possible through an unrestricted educational grant from Vasogen. About Vasogen |