Press Release
Source: Vasogen Inc.
Vasogen's Phase II Chronic Heart Failure Results Published in the Journal of the American College of Cardiology
Wednesday September 15, 8:30 am ET
Celacade(TM) Shown to Significantly Reduce the Risk of Death and Hospitalization in Patients with Advanced Chronic Heart Failure
TORONTO, Sept. 15 /CNW/ - Vasogen Inc. (NASDAQ:VSGN - News; TSX:VAS - News), announced today that comprehensive results from the Company's phase II trial of Celacade(TM) (immune modulation therapy) in advanced chronic heart failure patients were published in the September 15 issue of the Journal of the American College of Cardiology (JACC) (Vol 44, Issue 6, pp. 1181-1186). Heart failure affects approximately five million Americans.
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The article entitled "Effects of a Novel Immune Modulation Therapy in Patients With Advanced Chronic Heart Failure: Results of a Randomized, Controlled, Phase II Trial" was authored by Dr. Guillermo Torre-Amione, Medical Director of the Heart Transplant Service at the Methodist DeBakey Heart Center and Baylor College of Medicine; Dr. François Sestier, Faculty of Medicine at the University of Montreal; Dr. Branislav Radovancevic, Associate Director, Cardiovascular Surgery and Transplant Research, Texas Heart Institute; and Dr. James Young, Chairman, Division of Medicine at The Cleveland Clinic Foundation.
The clinical trial evaluated 73 patients with advanced chronic heart failure. All patients enrolled in the study were on stable doses of pharmaceuticals that reflect the standard of care, including angiotensin converting enzyme (ACE) inhibitors, beta blockers, digoxin, and diuretics.
The key findings were a significant reduction in the risk of death (p(equal sign)0.022; 1 vs. 7 deaths) and all-cause hospitalization (p(equal sign)0.008; 12 vs. 21 hospitalizations) for patients receiving Celacade(TM) compared to those receiving placebo. Analysis of a clinical composite score also demonstrated that patients receiving Celacade(TM) did significantly better than those receiving placebo (p(equal sign)0.006; linear trend). Patients were considered improved if, by the end of the study, they did not experience any major adverse clinical event during the course of the trial (defined as death or hospitalization for any cause) and their New York Heart Association (NYHA) classification improved by at least one functional class. Patients were considered worse if they experienced a major clinical event or reported worsening of their NYHA status. Significantly more patients receiving Celacade(TM) improved than in the group receiving placebo (31% vs. 11%, p(equal sign)0.046); conversely, significantly more patients in the placebo group worsened compared to patients receiving Celacade(TM) (65% vs. 33%, p(equal sign)0.010).
The published data also showed that patients receiving Celacade(TM) had significant improvements in key electrocardiogram (ECG) measures. Approximately 50% of patients diagnosed with chronic heart failure experience sudden death due to serious ventricular arrhythmia (irregular heartbeat originating in the ventricles of the heart), which has been linked to specific ECG abnormalities, including an increased QTc interval. The study showed a significant reduction in mean QTc interval of 18 milliseconds (msec) among assessable patients in the Celacade(TM) group (n(equal sign)20), compared to an increase of 12 msec in the placebo group (n(equal sign)15), resulting in a significant between-group difference at the end of the study (429 (+/-) 45 vs. 463 (+/-) 45 msec, p(equal sign)0.035).
The study also assessed the impact of Celacade(TM) on other parameters relevant to chronic heart failure, including NYHA classification, exercise tolerance, left ventricular ejection fraction (LVEF), quality of life and serious adverse events. While no significant differences were observed in exercise tolerance or LVEF between the Celacade(TM) treated patients and placebo, data indicated trends to improvement in both NYHA status and quality of life for patients receiving Celacade(TM). Celacade(TM) was also shown to be well-tolerated with no therapy-related significant adverse side effects or therapy-related withdrawals from the study.
"The positive impact that Celacade(TM) immune modulation therapy had on the key clinical endpoints of hospitalization and mortality is a major finding for the treatment of heart failure," said Dr. Guillermo Torre-Amione. "The results published in JACC formed the basis for the design of the ongoing pivotal phase III ACCLAIM study of Celacade(TM) in chronic heart failure patients, in which the primary outcome measure is the composite endpoint of mortality and cardiovascular hospitalization."
Vasogen is currently conducting the 2,000-patient pivotal phase III ACCLAIM trial in chronic heart failure patients, which is designed to support regulatory approvals and the commercial introduction of Celacade(TM) in North America and Europe. ACCLAIM will further evaluate the impact of Celacade(TM) on reducing mortality and morbidity in this patient population. Dr. Young, Chairman, Division of Medicine at The Cleveland Clinic Foundation, is the Chairman of the Steering Committee and Global Principal Investigator for the ACCLAIM trial. |
