Astellas Pharma and Vical asserts negative Phase 3 Clinical Trial results for ASP0113 for CMV-HSCT recipients
Astellas Pharma and Vical asserted the negative results for Phase 3 Helios Clinical Trial for ASP0113, an investigational DNA vaccine being developed for cytomegalovirus (CMV)-seropositive hematopoietic stem cell transplant (HSCT) recipients not meeting its primary or secondary endpoints in the same.
Bernhardt G. 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, We would like to thank the patients and clinicians who participated in this important trial.”
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. The Phase 3 trial was a 1:1 randomized, double-blind, placebo-controlled study that enrolled a total of 514 CMV seropositive subjects undergoing hematopoietic stem cell transplantation. Randomization was stratified by donor-recipient relatedness and donor CMV serostatus.