SAN DIEGO & TOKYO—June 25, 2013—Vical Incorporated (Nasdaq: VICL) and Astellas Pharma Inc. (TOKYO: 4503) today announced the initiation of a multinational Phase 3 registration trial of ASP0113 (TransVax™), in approximately 500 hematopoietic cell transplant (HCT) recipients. Vical and Astellas entered into exclusive worldwide license agreements in 2011 to develop and commercialize ASP0113, Vical’s investigational therapeutic vaccine designed to control cytomegalovirus (CMV) in transplant recipients. Astellas is conducting the trial, and Vical is providing development, regulatory and manufacturing support. The companies expect to begin a separate Phase 2 trial of ASP0113 in solid organ transplant (SOT) recipients later this year.
“There still remains high unmet medical needs to control CMV in transplant recipients. We are pleased to advance ASP0113 program in a highly challenging HCT recipient population.” said Yoshihiko Hatanaka, President and Chief Executive Officer of Astellas.
“With the initiation of this trial, ASP0113 becomes the first investigational therapeutic CMV vaccine to reach Phase 3 testing,” said Vijay Samant, President and Chief Executive Officer of Vical. “Therapeutic vaccines, designed to control disease in people with established and persistent infections, represent the highest hurdle in vaccinology. We are excited to achieve this important milestone as we continue advancing ASP0113 toward commercialization.”
The Phase 3 trial protocol was designed to support full approval of ASP0113 for the HCT indication. The 1:1 randomized, double-blind, placebo-controlled trial will enroll CMV seropositive subjects undergoing HCT procedures. Randomization will be stratified by donor-recipient relatedness and donor CMV serostatus. The trial will use an adaptive design composed of two parts. The first part will enroll approximately 100 subjects and the primary endpoint will be overall survival at one year. The second part will enroll approximately 400 subjects and the primary endpoint will be either survival or a composite endpoint including survival and other variables, depending on the statistical analysis of results from the first part. Enrollment will continue uninterrupted through both parts, and the endpoint for the second part will be determined by the time enrollment is complete. Treatment and follow-up for each subject will continue for one year following enrollment. The trial design was reviewed by regulatory agencies in the United States, Europe and Japan.