Immunogenicity and Favorable Tolerability Observed in Phase II Clinical Trial for H5N1 Influenza Vaccine ASP7373
March 13, 2012-Astellas Pharma Inc. (TSE:4503; Headquarters,
Tokyo; President & CEO, Yoshihiko Hatanaka;
”Astellas”) and UMN Pharma Inc. (Headquarters, Akita;
CEO Shu-ichi Kanazashi; ”UMN”) today announced that the
immunogenicity and favorable tolerability have been observed in
Phase II clinical trial for the H5N1 influenza HA vaccine ASP7373
(UMN’s development code: UMN-0501). Astellas has been
pursuing drug development of this vaccine in cooperation with
UMN.
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. As announced on November 11, 2011, the
administration of ASP7373 had been successfully completed, and
Astellas had been evaluating the data.
Astellas and UMN are happy to announce that immunogenicity and
favorable tolerability have been observed, and no serious adverse
events have been reported.
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 started the clinical development of ASP7373 in
2008 and has already completed three clinical studies in
Japan.
Posted: March 2012
