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Interim Safety Data Favorable for Vical's Phase 2 Trial of DNA Vaccine Against CMV
Date:10/17/2007

SAN DIEGO, Oct. 17 /PRNewswire-FirstCall/ -- Vical Incorporated (Nasdaq: VICL) today announced that an independent data safety monitoring board (DSMB) found no safety issues and recommended continuation of the company's Phase 2 trial of a DNA vaccine against cytomegalovirus (CMV). The DSMB completed an interim evaluation of safety data after the two-month follow-up visits for the first 20 hematopoietic stem cell transplant (HCT) recipients enrolled in the study.

Because most HCT recipients are expected to face a natural viral challenge as pre-existing CMV infection reactivates under immunosuppression, the primary efficacy endpoint in the double-blind, placebo-controlled Phase 2 trial is the occurrence rate of clinically significant CMV levels in HCT patients receiving vaccine compared with patients receiving placebo. Other important endpoints include immune responses against the specific CMV features targeted by the vaccine. The trial also is comparing safety of the vaccine against placebo in up to 80 matched, related HCT donors and recipients, and up to 80 additional HCT recipients. The DSMB evaluated safety data only in the interim analysis.

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. While a healthy immune system typically protects an infected person against CMV disease, it rarely succeeds in completely eliminating the infection, and those whose immune systems are not fully functional are at high risk of CMV proliferation, potentially leading to severe illness or death. These include transplant patients who take immunosuppressive drugs, and fetuses and newborns of mothers who first be
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SOURCE Vical Incorporated
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