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Vical Expands Applications of Vaxfectin(R) Adjuvant for Infectious Disease and Cancer Vaccines; 80% to 100% of High-Dose Responders in H5N1 Clinical Trials Still Responding at 6 Months
Date:10/8/2008

fluenza vaccine generated broader, more balanced antibody responses than unformulated vaccine, and also generated influenza-specific T-cell responses. Adjusting the ratio of Vaxfectin(R) to vaccine drove substantial increases in either antibody or T-cell responses, without reducing the other type of response, compared with unformulated vaccine. The ability to favor primarily antibody or T-cell responses could provide important advantages in developing vaccines for specific applications.

H5N1 Pandemic Influenza Vaccine Phase 1 Trial Update

Vical reported in July that the company's Vaxfectin(R)-formulated H5N1 pandemic influenza DNA vaccines achieved potentially protective levels of antibody responses (H5 hemagglutination inhibition, or HI, titers of at least 40 and at least a four-fold increase from baseline) in at least 50% and up to 67% of evaluable subjects in the higher dose cohorts in a 100-subject Phase 1 trial.

Following injections at Days 0 and 21, responses peaked by Day 56, and more than 90% of the responders had sustained responses through the last measurement (Day 84) at the time of the preliminary analysis. Expanded data presented today shows that in the two cohorts receiving the highest H5 DNA dose (1 mg), 80% to 100% of the responders had sustained responses through Day 182. Similar results for a vaccine deployed during the early stages of a pandemic outbreak could provide substantial protection to the at-risk population and potentially alter the course of the pandemic.

These results support further development of Vaxfectin(R)-formulated DNA vaccines, and could position them as potential alternatives to conventional vaccines. DNA vaccines are fundamentally different from conventional vaccines because they do not contain any part of the virus itself, and may offer compelling advantages in response to a pandemic outbreak because of significantly reduced development and manufacturing times. Vical is currently seeking funding to
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SOURCE Vical Incorporated
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