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Astellas and Vical Announce Initiation of Phase 2 Trial of ASP0113, a Cytomegalovirus Vaccine, in Solid Organ Transplant Recipients
Date:12/10/2013

NORTHBROOK, Ill. and SAN DIEGO, Dec. 10, 2013 /PRNewswire/ -- Astellas Pharma Global Development, Inc., a subsidiary of Tokyo-based Astellas Pharma Inc. (Tokyo: 4503), and Vical Incorporated (Nasdaq: VICL) today announced the initiation of a Phase 2 trial of ASP0113 in approximately 140 solid organ transplant (SOT) recipients.

The global, randomized, double-blind, placebo-controlled trial is designed to evaluate the efficacy of ASP0113 compared to placebo as measured by the incidence of cytomegalovirus (CMV) viremia in CMV-seronegative subjects receiving a kidney from a CMV-seropositive donor. The study will also evaluate the safety of ASP0113 in this patient population. Follow-up for each subject will continue for one year following enrollment.

"Following the initiation of our Phase 3 trial of ASP0113 in hematopoietic cell transplant (HCT) recipients in June, we are pleased to expand the ASP0113 program with this Phase 2 trial in SOT recipients," said Bernie Zeiher, Senior Vice President and Global Therapeutic Area Head of Immunology and Infectious Diseases at Astellas Pharma Global Development, Inc. "The unmet medical need to control CMV in transplant recipients remains high."

"We are very pleased with the collaborative nature of our relationship with Astellas and with the progress being made," said Vijay Samant, President and Chief Executive Officer of Vical.

Astellas is conducting the trial under an exclusive worldwide license agreement with Vical to develop and commercialize ASP0113. Vical is providing development, regulatory and manufacturing support.

About ASP0113
ASP0113 (formerly TransVax™) is an investigational bivalent DNA vaccine containing plasmids (closed loops of
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SOURCE Astellas Pharma US, Inc.
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