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CMV vaccine misses its mark
November 2016
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SAN DIEGO & TOKYO—A Phase 2 study assessing the safety and efficacy of cytomegalovirus (CMV) vaccine ASP0113 missed its primary endpoint, Vical Inc. and Astellas Pharma Inc. reported in a press release. The study compared ASP0113 with placebo in kidney transplant patients receiving an organ from a CMV-seropositive donor. The primary endpoint 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. The secondary endpoints of CMV-associated disease and CMV-specific antiviral therapy were similar in both treatment groups, as were safety profiles.
 
“The unmet medical need in addressing CMV infection in transplant patients remains high. Although we had hoped for a different outcome, we look forward to further analyzing these data in hopes of contributing knowledge to the future development programs in this patient population,” remarked Dr. Bernhardt G. Zeiher, president of development at Astellas.

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