Astellas Pharma, Vical Begin Phase 2 Trial Of ASP0113 - Quick Facts

(RTTNews) - Astellas Pharma Global Development, Inc., an unit of Tokyo-based Astellas Pharma Inc.,(ALPMY) and Vical Inc.(VICL), Tuesday announced the initiation of a Phase 2 trial of ASP0113 in about 140 solid organ transplant or SOT recipients. The study is designed to evaluate the safety and efficacy of ASP0113 compared to placebo as measured by the incidence of cytomegalovirus viremia in CMV-seronegative subjects receiving a kidney from a CMV-seropositive donor.

ASP0113, formerly known as TransVax is an investigational bivalent DNA vaccine containing plasmids (closed loops of DNA) encoding human CMV pp65 and gB antigens for induction of both cellular and humoral immune responses.

Astellas is conducting the trial under an exclusive worldwide license agreement with Vical to develop and commercialize ASP0113. Vical is providing development, regulatory and manufacturing support.