TUESDAY, SEPTEMBER 27, 2016

Vical and Astellas initiate Phase III trial of cytomegalovirus vaccin

Vical Incorporated, a San Diego-based biopharmaceutical company, and Astellas Pharma, Inc., a Tokyo-based pharmaceutical company, announced the initiation on Tuesday of a multi-national Phase III trial of a vaccine to control cytomegalovirus.

The trial will test ASP0113, also known as TransVax, in approximately 500 hematopoietic cell transplant recipients. CMV is a herpes virus that infects more than half of all U.S. adults by age 40 and can cause severe illness or death in patients with compromised immune systems.

"With the initiation of this trial, ASP0113 becomes the first investigational therapeutic CMV vaccine to reach Phase III testing," Vijay Samant, the president and CEO 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."

Vical and Astellas entered into an exclusive worldwide license agreement in 2011 to commercialize and develop ASP0113. Vical is providing development, manufacturing and regulatory support and Astellas is conducting the trial.

"There still remains high unmet medical needs to control CMV in transplant recipients," Yoshihiko Hatanaka, the president and CEO of Astellas, said. "We are pleased to advance ASP0113 program in a highly challenging HCT recipient population."

The two companies anticipate the beginning of a separate Phase II trial of ASP0113 in solid organ transplant recipients later in 2013.