Celacade was also shown to be safe and well tolerated in the trial, which was named ACCLAIM. The results were presented at the World Congress of Cardiology 2006 in Barcelona, Spain.
“The 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 Guillermo Torre-Amione, medical director of the heart transplant program at The Methodist Hospital. “These findings are consistent with the role that chronic inflammation plays in the development and progression of heart failure and are particularly impressive.”
As previously reported, the difference in time to death or first cardiovascular hospitalization for the intent-to-treat study population was not statistically significant. However, the risk reduction directionally favored the Celacade group
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. Celacade was also shown to significantly reduce the risk of death or first cardiovascular hospitalization by 39%.
“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,” said Dr James Young, chairman of the steering committee for the trial.
Consistent with the impact of Celacade on the risk of mortality and morbidity in major subgroups within the trial was the finding of a significant improvement in quality of life for the intent-to-treat study population
Vasogen said they were now making preparations to meet with the FDA and Health Canada to present this data. They commented that they had commenced planning a follow-on study to support wider adoption in the heart failure population.