Initial results from the 2,414 patient phase III trial in advanced chronic heart failure (HF), named ACCLAIM, showed that the study failed to meet its primary endpoint of reducing the risk of death and cardiovascular hospitalization in the total population.
The endpoint was met for the subgroup of 692 patients with New York Heart Association (NYHA) class II chronic HF.
In addition to a number of secondary endpoints in the study, changes in high-sensitivity C-reactive protein (hs-CRP) were measured at baseline and 26 weeks. While changes in hs-CRP directionally favored the Celacade group, the between group differences did not reach statistical significance in the intent to treat population.
Vasogen said that it is continuing data analysis, and complete results for the ACCLAIM study are scheduled to be presented at this year's World Congress of Cardiology in September.
However, until that time, Vasogen's chances of recovering from the blow and regaining investor confidence are not looking good. Indeed, Canaccord Adams analyst Joseph Pantginis told Bloomberg News that he believes “Vasogen is dead money for the next three to six months.”