Astellas, Vical: Cytomegalovirus Vaccine ASP0113 Trial Fails To Meet Endpoints

(RTTNews) - Japan's Astellas Pharma Inc. and Vical Inc. (VICL) announced Monday that ASP0113, an investigational DNA vaccine being developed for cytomegalovirus or CMV-seropositive hematopoietic stem cell transplant or HSCT recipients, did not meet its primary or secondary endpoints in the Phase 3 HELIOS clinical trial.

The vaccine was generally well tolerated, with injection-site reactions being the most commonly reported adverse event.

The companies said the Phase 3 trial was designed to evaluate the efficacy of ASP0113 compared with placebo in CMV-seropositive recipients undergoing an allogeneic stem cell transplant. Efficacy was assessed using a primary composite endpoint of overall mortality and CMV end-organ disease through the first year following the transplant, an endpoint which was not met.

Secondary endpoints of time to first protocol-defined CMV viremia and time to first use of adjudicated CMV-specific antiviral therapy also were not met.

Bernhardt Zeiher, president of Development, Astellas said, "We are disappointed that the results did not demonstrate a significant improvement in overall survival and reduction in CMV end-organ disease."