Vical and Astellas' CMV vaccine fails to meet Phase II endpoint

USA-based Vical (Nasdaq: VICL) saw its shares plunge 24.74% to $2.90 after the company announced disappointing new mid-stage trial data with its cytomegalovirus (CMV) vaccine, ASP0113.

The vaccine is partnered with Japan’s Astellas Pharma Inc. (TOKYO:4503), with the companies announcing top-line results from a randomized, double-blind, placebo-controlled Phase II study evaluating the safety and efficacy of ASP0113 versus placebo in kidney transplant patients receiving an organ from a CMV-seropositive donor.

Results from the study demonstrated that the trial did not meet its primary endpoint, which was the proportion of patients having CMV viremia defined as a plasma viral load of ≥ 1000 IU/mL by central laboratory assay through one year after first injection of study drug. Additionally, the secondary endpoints of CMV-associated disease and CMV-specific antiviral therapy, which were evaluated by an independent, blinded Adjudication Committee, were similar in both treatment groups.