Vical (VICL), Astellas Pharma Finalize TransVax Phase 3 Design

Vical Incorporated (Nasdaq: VICL) announced that Astellas Pharma and Vical have finalized the general design of a pivotal, multinational Phase 3 trial of TransVax, the companies' therapeutic cytomegalovirus (CMV) vaccine for transplant recipients. This progress triggers a $10 million milestone payment to Vical. Based on guidance from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), the companies have confirmed that CMV disease will not be the primary endpoint in the Phase 3 trial.

The companies expect to initiate the Phase 3 trial of TransVax for hematopoietic stem cell transplant (HSCT) recipients in the second half of 2012, and initiate a Phase 2 efficacy trial of TransVax™ for solid organ transplant (SOT) recipients shortly thereafter. Specific endpoints and trial design concepts will be announced when the trials begin. Vical and Astellas entered into exclusive worldwide license agreements in 2011 to develop and commercialize TransVax.

Under the services and supply agreement, Vical will manufacture TransVax for Astellas through the remaining clinical development and commercial launch.

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