FINALLY Best In Class Data CONFIRMED
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New Data from Vasogen's ACCLAIM Trial in Heart Failure Presented at World Congress of Cardiology 2006
- 31% Risk Reduction in Combined Group of Class III/IV Patients with No Prior Heart Attack and All Class II Patients -
New Data Define Prime Target Population for Commercial Development
MISSISSAUGA, ON, Sept. 3 /CNW/ - Vasogen Inc. (NASDAQ:VSGN; TSX:VAS), a leader in the research and commercial development of technologies targeting the chronic inflammation underlying cardiovascular and neurological disease, today announced that new data from the 2,400-patient ACCLAIM trial in chronic heart failure showed that in a major combined subgroup of New York Heart Association (NYHA) Class III/IV patients with no prior history of heart attack and all Class II patients, together comprising more than 50% of the study population, Vasogen's Celacade(TM) technology reduced the risk of death and cardiovascular hospitalization by 31% (n= 1,305 patients, p=0.0003). Celacade was also shown to be safe and well tolerated. The results were presented today by Guillermo Torre-Amione MD, PhD, at a late breaking clinical trial Hot Line Session of the World Congress of Cardiology 2006 in Barcelona, Spain.
"The ACCLAIM results provide compelling evidence that Celacade significantly reduces the risk of death and cardiovascular hospitalization in an important group of heart failure patients that remain underserved by available therapies," stated Dr. Torre-Amione, Medical Director, Heart Transplant Program, Methodist DeBakey Heart Center at The Methodist Hospital, and Principal Investigator for the U.S. arm of the ACCLAIM trial. "These findings are consistent with the role that chronic inflammation plays in the development and progression of heart failure and are particularly impressive in the large subgroup of NYHA Class III/IV patients who had not experienced a prior heart attack and in all NYHA Class II patients. These results provide a strong basis for targeting Celacade's novel anti-inflammatory mechanism in this large and well-defined patient population."
As previously reported, the difference in time to death or first cardiovascular hospitalization (the primary endpoint) for the intent-to-treat study population was not statistically significant (p=0.22), however, the risk reduction directionally favoured the Celacade group (hazard ratio=0.92).
New findings presented today demonstrated that Celacade significantly reduced the risk of death or first cardiovascular hospitalization by 26% in patients with non-ischemic heart failure, as indicated by no prior history of heart attack at baseline (n=919 patients, 243 events, p=0.02). As previously reported, in patients with NYHA Class II heart failure at baseline, Celacade was also shown to significantly reduce the risk of death or first cardiovascular hospitalization by 39% (n=689 patients, 216 events, p=0.0003).
New data also presented today included a combined analysis of NYHA Class III/IV patients with no prior history of heart attack and all NYHA Class II patients, which demonstrated a 31% reduction in the risk of death or first cardiovascular hospitalization in the Celacade group compared to placebo (n=1,305 patients, 391 events, p=0.0003).
In addition, an exploratory analysis based on pre-specified subgroups, which comprised 72% of the patient population and excluded only those patients in NYHA Class III/IV with a prior history of heart attack and an ejection fraction equal to or below the median (EF(less than or equal to)23%), showed that Celacade reduced the risk of death or first cardiovascular hospitalization by 21% (n=1,746 patients, 560 events, p=0.005).
"The consistency and strength of the risk reductions seen across a number of large subgroups in ACCLAIM is very compelling, particularly considering that the patients in this trial were receiving the best standard of care of any heart failure trial I have seen published to date," said Dr. James Young, Chairman, The Cleveland Clinic Foundation, Medical Director, Kaufman Center for Heart Failure, and Chairman of the Steering Committee for the ACCLAIM trial. "Of particular interest is the strong finding in the combined subgroup of patients with non-ischemic cardiomyopathy and those with NYHA Class II symptoms regardless of etiology - results that will now drive the commercial development of Celacade. Based on these findings, we now see an opportunity to benefit a large and rapidly growing segment of the heart failure population,
where the risk of mortality and morbidity remains unacceptably high."
Consistent with the impact of Celacade on the risk of mortality and morbidity in major subgroups within the ACCLAIM trial was the finding of a significant improvement in quality of life (as measured by the Minnesota Living with Heart Failure Questionnaire) for the intent-to-treat study population (n=2,408 patients, p=0.04). Celacade was also shown to be safe and well tolerated, and there were no significant between-group differences for any serious adverse events.
"The data presented today provide convincing evidence that Celacade offers therapeutic benefit in the treatment of a large and underserved population of chronic heart failure patients," stated David Elsley, President and CEO of Vasogen. "We believe that the significant risk reduction observed in NYHA Class II patients is sufficiently robust to warrant consideration for
regulatory approval in the United States and Canada, and we are now making preparations to meet with the FDA and Health Canada to present these data.
Furthermore, we believe that the impact of Celacade on patients with non-ischemic heart failure and those in NYHA Class II offers significant commercial potential in Europe under our existing CE Mark - a strategy we are actively discussing with prospective marketing partners. Finally, based on the ACCLAIM results and recommendations from the Steering Committee, we have commenced planning a follow-on study to support wider adoption in the heart failure population." |
