Astellas and Vical Announce Top-Line Results for Phase 3 Trial of Cytomegalovirus Vaccine ASP0113 in Hematopoietic Stem Cell Transplant Recipients

Astellas Pharma (TSE:4503) and Vical (NASDAQ:VICL) announced that ASP0113, an investigational DNA vaccine being developed for cytomegalovirus-seropositive hematopoietic stem cell transplant 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.
As quoted in the press release:

“We are disappointed that the results did not demonstrate a significant improvement in overall survival and reduction in CMV end-organ disease,” said Bernhardt G. Zeiher, president of Development, Astellas. “We would like to thank the patients and clinicians who participated in this important trial.”

Click here to read the full press release.