September 18, 2007 - Vasogen Inc. announced plans for a confirmatory study of its Celacade technology for the treatment of patients with NYHA Class II heart failure, in order to support an application for regulatory approval in the U.S.
Celacade technology is designed to target the inflammation underlying chronic heart failure and other cardiovascular diseases. The company says as few as 300 patients could provide sufficient data to confirm the finding of the phase III ACCLAIM trial, which demonstrated a 39 percent reduction (p equals 0.0003) in the risk of death or cardiovascular hospitalizations for the large pre-specified subgroup of 689 NYHA class II heart failure patients.
The company commercialize Celacade by year-end in the European Union, where Celacade has already received CE Mark regulatory approval for the treatment of NYHA Class II heart failure.
After Vasogen presented the FDA with the ACCLAIM trial data, which demonstrated a 39 percent reduction (p equals 0.0003) in the risk of death and cardiovascular hospitalizations for the large pre-specified subgroup of 689 NYHA class II heart failure patients, the FDA recommended that Vasogen conduct a confirmatory study to support a U.S. Pre-Market Approval filing for Celacade for NYHA Class II heart failure patients and also recommended that the Company consider utilizing a Bayesian approach.
This approach involves a trial design methodology that allows utilization of prior trial results to contribute to the statistical power of a confirmatory study and therefore provides the opportunity to significantly reduce the number of required patients, as well as the cost and duration of the study.
For more information: www.vasogen.com