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Vical Completes Enrollment and Reports Positive Interim Data in CMV Vaccine Phase 2 Trial
Date:11/12/2008

SAN DIEGO, Nov. 12 /PRNewswire-FirstCall/ -- Vical Incorporated (Nasdaq: VICL) announced today that the company has completed enrollment of subjects in a Phase 2 trial of its therapeutic DNA vaccine designed to prevent cytomegalovirus (CMV) reactivation and disease in immunosuppressed stem cell transplant recipients. An interim analysis of immunogenicity data for the first 33 transplant recipients in the recipient-only arm of the study showed significant (p<0.05) post-transplant enhancement of CMV-specific T-cell responses in subjects receiving vaccine compared with subjects receiving placebo.

"These patients are highly immunosuppressed after transplant and, due to pre-existing infection, are at risk of CMV reactivation and the associated disease," said Ronald B. Moss, M.D., Vical's Vice President of Clinical Development. "The inducement of CMV-specific T-cell responses after transplant is encouraging, as others have noted that T-cell responses may be predictive of better control of CMV reactivation and disease. These encouraging immunogenicity data should translate into clinical benefit, and should be confirmed by clinical efficacy results in the second quarter of 2009."

The company conducted an interim immunogenicity analysis on post-transplant sera from the first 47 stem cell transplant recipients (33 in the recipient-only arm and 14 in the donor-recipient arm). The resulting data were analyzed by treatment group, but clinical sites and trial participants remain blinded to individual treatment codes. The results indicated significant enhancement of CMV-specific immunity in the recipient-only arm as measured by T-cell responses to the two CMV antigens targeted by the vaccine: pp65 (p<0.05) and gB (p<0.05). Results for the
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