Astellas Pharma Inc. (Headquarters, Tokyo; President & CEO, Yoshihiko Hatanaka) today announced that the administration of the recombinant influenza HA vaccine (H5N1) ASP7373 (former code: UMN-0501) was successfully completed in the currently ongoing phase II clinical trial. Astellas Pharma has been pursuing drug development of this vaccine in cooperation with UMN Pharma Inc. (Headquarters, Akita; CEO, Shu-ichi Kanazashi).
This clinical study enrolled 180 healthy adult volunteers, and aims to comparatively evaluate the immunogenicity and safety among the three doses of ASP7373 to determine the optimal clinical dose. ASP7373 was administered intramuscularly two times with three weeks interval.
The recombinant influenza HA vaccine (H5N1) ASP7373 has been produced by the cell-culture manufacturing method employing the Baculovirus Expression Vector System (BEVS), a next-generation technology platform for manufacturing of biopharmaceutical products. UMN Pharma started the clinical development of ASP7373 in 2008 and has already completed three clinical studies in Japan.