Vical and Astellas Announce Initiation of Phase 3 Trial of ASP0113 Cytomegalovirus Vaccine

Vical and Astellas Announce Initiation of Phase 3 Trial of ASP0113
Cytomegalovirus Vaccine

First Therapeutic CMV Vaccine to Reach Phase 3

SAN DIEGO and TOKYO, June 25, 2013 (GLOBE NEWSWIRE) -- 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.

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"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

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.

About ASP0113

ASP0113 is an investigational bivalent DNA vaccine containing plasmids (closed
loops of DNA) encoding human CMV pp65 and gB antigens for induction of both
cellular and humoral immune responses. ASP0113 is formulated with a
proprietary poloxamer-based delivery system. ASP0113 has received orphan drug
designation in the United States and Europe for HCT and SOT patients.

About CMV

CMV is a herpes virus that infects more than half of all adults in the United
States by age 40, and is even more widespread in developing countries. A
healthy immune system typically protects an infected person against CMV
disease, but does not prevent or clear latent infection, and those whose
immune systems are not fully functional are at high risk of CMV reactivation,
potentially leading to severe illness or death. Those at greatest risk include
transplant patients and infants born to mothers who first become infected
during pregnancy. Vical is pursuing two distinct vaccine approaches for these
separate market segments: ASP0113 for the transplant market and CyMVectin™ for
the congenital disease market.

About Astellas

Astellas Pharma Inc., located in Tokyo, Japan, is a pharmaceutical company
dedicated to improving the health of people around the world through the
provision of innovative and reliable pharmaceutical products. Astellas has
approximately 17,000 employees worldwide. The organization is committed to
becoming a global category leader in Urology, Immunology (including
Transplantation) and Infectious diseases, Oncology, Neuroscience and DM
Complications and Kidney diseases. For more information on Astellas Pharma
Inc., please visit

About Vical

Vical researches and develops biopharmaceutical products based on its patented
DNA delivery technologies for the prevention and treatment of serious or
life-threatening diseases. Potential applications of the company's DNA
delivery technology include DNA vaccines for infectious diseases or cancer, in
which the expressed protein is an immunogen; cancer immunotherapeutics, in
which the expressed protein is an immune system stimulant; and cardiovascular
therapies, in which the expressed protein is an angiogenic growth factor. The
company is developing certain infectious disease vaccines and cancer
therapeutics internally. In addition, the company collaborates with major
pharmaceutical companies and biotechnology companies that give it access to
complementary technologies or greater resources. These strategic partnerships
provide the company with mutually beneficial opportunities to expand its
product pipeline and address significant unmet medical needs. Additional
information on Vical is available at

This press release contains forward-looking statements subject to risks and
uncertainties that could cause actual results to differ materially from those
projected. Forward-looking statements include statements about Vical's
technologies, the ASP0113 CMV vaccine, as well as the company's focus,
licensees, and independent and partnered product candidates. Risks and
uncertainties include whether Vical, Astellas or others will continue
development of ASP0113 or any other product candidates; whether the companies
will begin a Phase 2 trial of ASP0113 in SOT recipients later this year, if at
all; whether the Phase 3 and Phase 2 trials of ASP0113 will be completed, and
if so, whether results will support advancement to commercialization for HCT
or SOT recipients; whether Astellas will successfully develop and
commercialize ASP0113; whether Vical will provide assistance to Astellas with
manufacturing, regulatory and development activities; whether Astellas will
reimburse all, if any, of Vical's ASP0113-related costs; whether Vical or its
licensees will seek or gain approval to market ASP0113 or any other DNA-based
human vaccine or therapeutic product candidates; whether Vical or its
licensees will succeed in marketing any product candidates; and additional
risks set forth in the company's filings with the Securities and Exchange
Commission. These forward-looking statements represent the companies' judgment
as of the date of this release. The companies disclaim, however, any intent or
obligation to update these forward-looking statements.

CONTACT: Vical Incorporated
         Alan R. Engbring
         Astellas Pharma Inc.
         Corporate Communications

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