Vical Inc. and Astellas Pharma's Phase 2 study of cytomegalovirus (CMV) vaccine ASP0113 has achieved topline results.
The trial, which was randomized, double-blind and placebo-controlled, assessed the safety and effectiveness of ASP0113 compared to placebo in patients who have had kidney transplants and received the organ from CMV-seropositive donors.
"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,” Astellas President of Development Bernhardt Zeiher said. “In addition, we continue to focus on execution of our Phase 3 study in hematopoietic cell transplant (HCT) recipients and are pleased to announce that we have met our target enrollment.”
The treatment groups experienced similar safety profiles, but local injection site reactions in the ASP0113 group were more common.
“We are pleased with our collaborative relationship with Astellas, and we look forward to the results from the pivotal Phase 3 study in HCT recipients, which we expect to obtain during the fourth quarter of 2017,” Vical President and CEO Vijay Samant said.