Vical receives EMA Scientific Advice for Phase 3 trial of TransVax therapeutic CMV vaccine

Vical Incorporated (Nasdaq:VICL) announced today the receipt of Scientific Advice from the European Medicines Agency (EMA) recommending practical efficacy endpoints for a Phase 3 trial of the company's TransVax™ therapeutic cytomegalovirus (CMV) vaccine. Because the incidence of CMV disease is low and the target population—recipients of hematopoietic cell transplants—is small, the EMA agreed with the company's position that a CMV disease endpoint is not practical. The EMA also provided positive comments on important features of the proposed trial design and overall product development pathway.

Vical is currently evaluating plans for the pivotal Phase 3 trial with the U.S. Food and Drug Administration (FDA). The company will provide additional information about the trial upon completion of regulatory agency discussions, and expects to begin the planned Phase 3 trial in the second half of 2011.

Vical's TransVax™ Therapeutic CMV Vaccine

To address the unmet need to protect transplant patients from CMV reactivation, Vical is developing TransVax™, a therapeutic DNA vaccine encoding the CMV glycoprotein B (gB) antigen and the CMV phosphoprotein 65 (pp65) antigen, and formulated with a poloxamer designed to enhance plasmid delivery and protein expression, resulting primarily in an increased cellular immune response. Vical's TransVax™ vaccine has U.S. orphan drug designation for transplant patients. In September 2010, Vical announced statistically significant immunogenicity and clinical efficacy results with no safety issues from a completed Phase 2 trial of the TransVax™ vaccine in patients undergoing hematopoietic stem cell transplants.