Astellas, Vical Initiate Phase 2 Trial of ASP0113 Vaccine in Solid Organ Transplant Recipients
Astellas Pharma Global Development, a subsidiary of Tokyo-based Astellas Pharma Inc. (OTC: ALPMY), and Vical Incorporated (Nasdaq: VICL) today announced the initiation of a Phase 2 trial of ASP0113 in approximately 140 solid organ transplant (SOT) recipients.
The global, randomized, double-blind, placebo-controlled trial is designed to evaluate the efficacy of ASP0113 compared to placebo as measured by the incidence of cytomegalovirus (CMV) viremia in CMV-seronegative subjects receiving a kidney from a CMV-seropositive donor. The study will also evaluate the safety of ASP0113 in this patient population. Follow-up for each subject will continue for one year following enrollment.