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Vical Reports Third Quarter 2008 Financial Results and Continued Progress in Product Development Programs
Date:11/5/2008

he higher dose cohorts in a 100-subject Phase 1 trial. Expanded data presented in October showed that in the highest dose cohorts, responses peaked by Day 56 and were sustained in 80% to 100% of the responders through the end of the study at Day 182.

Vaxfectin(R) Developments

In addition to the successful initial human application of the Vaxfectin(R) adjuvant in the H5N1 pandemic influenza vaccine program, Vaxfectin(R)-formulated DNA vaccines have been well-tolerated and have demonstrated significant immune responses in multiple animal models, including nonhuman primates. Vaxfectin(R) has also demonstrated a dose-sparing effect (the ability to achieve the same vaccine effectiveness with lower vaccine doses) with the commercial seasonal influenza and government-stockpiled H5N1 pandemic influenza vaccines. Vaxfectin(R) may have potential applications as an adjuvant for other protein-based vaccines against infectious diseases and cancer as well. The Vaxfectin(R) adjuvant is currently being evaluated by potential partners for a variety of additional vaccine applications, and continued progress was reported over the past few months, including:

-- New mouse data with Vaxfectin(R)-formulated seasonal influenza vaccines demonstrating the ability to adjust the ratio of Vaxfectin(R) to vaccine and drive substantial increases in either antibody or T-cell responses, without reducing the other type of response, compared with unformulated vaccine;

-- A mouse study demonstrating a 100-fold increase in antigen-specific CD8+ T-cell responses with a Vaxfectin(R)-formulated cancer vaccine compared with unformulated vaccine;

-- A research collaboration with the Karolinska Institutet and the Swedish Institute for Infectious Disease Control to evaluate a Vaxfectin(R)-formulated preventive DNA vaccine against HIV in a Phase 1 human clinical trial as part of a prime-boost regimen; and

-- Publication in the August issue of "Clinical and Vaccine Immu
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