Vical Presents Pandemic Influenza Vaccine Results and Outlook At WHO Meeting
- Category: Vaccines
- Published on Sunday, 15 February 2009 17:33
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GENEVA, Switzerland | February 13, 2009 | Vical Incorporated (Nasdaq:VICL) today presented to the world's leading pandemic influenza vaccine experts a summary of complete results from the company's successful Phase 1 trial and future goals for its pandemic influenza DNA vaccine program
GENEVA, Switzerland | February 13, 2009 | Vical Incorporated (Nasdaq:VICL) today presented to the world's leading pandemic influenza vaccine experts a summary of complete results from the company's successful Phase 1 trial and future goals for its pandemic influenza DNA vaccine program. Larry R. Smith, Ph.D., Vical's Vice President of Vaccine Research, presented the results and outlook at the invitation-only 5th WHO Meeting on Evaluation of Pandemic Influenza Prototype Vaccines in Clinical Trials (Geneva - February 12-13).
The double-blind, placebo-controlled, dose-escalation Phase 1 trial was conducted in approximately 100 healthy volunteers age 18 to 45 at three U.S. clinical sites. The trial was designed to assess safety and immunogenicity following vaccination, and to evaluate monovalent and trivalent Vaxfectin(r)-formulated H5N1 pandemic influenza DNA vaccines at various doses. The vaccines were safe and well-tolerated in the trial, and induced antibody responses and T-cell responses against a matching strain of influenza virus, and cross-clade antibody responses against different strains. Highlights of previously reported results include:
- H5 antibody responses predictive of protection in up to 67% of evaluable subjects at higher doses, in the same range as published protein-based H5 vaccine results;
- H5 antibody responses that persisted through end of study at Day 182, suggesting potentially durable protection;
- Antibody responses against H5 influenza virus strains from two different clades, suggesting protection against emerging strains that may not match the vaccine;
- H5 T-cell responses in 75% to 100% of evaluable subjects in the various monovalent cohorts, offering broader potential protection than antibodies alone;
- Antibody and/or T-cell responses against one or more antigens in 72% of subjects in trivalent cohorts, including specific responses against conserved influenza virus proteins;
- No significant safety issues observed at any of the vaccine doses tested, clearing the path for additional human trials of Vaxfectin(r)-adjuvanted vaccines.
Vical is currently exploring potential sources of funding for further development toward commercialization. The company's near-term goals are to confirm vaccine safety and immunogenicity in a larger number of subjects, optimize vaccine dose and adjuvant ratio, explore prime-boost regimens with different vaccines, and leverage the Phase 1 proof of concept for its DNA vaccine platform and Vaxfectin(r) adjuvant into additional indications.
Vical researches and develops biopharmaceutical products based on its patented DNA delivery technologies for the prevention and treatment of serious or life-threatening diseases. Potential applications of the company's DNA delivery technology include DNA vaccines for infectious diseases or cancer, in which the expressed protein is an immunogen; cancer immunotherapeutics, in which the expressed protein is an immune system stimulant; and cardiovascular therapies, in which the expressed protein is an angiogenic growth factor. The company is developing certain infectious disease vaccines and cancer therapeutics internally. In addition, the company collaborates with major pharmaceutical companies and biotechnology companies that give it access to complementary technologies or greater resources. These strategic partnerships provide the company with mutually beneficial opportunities to expand its product pipeline and address significant unmet medical needs. Additional information on Vical is available at www.vical.com.
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This press release contains forward-looking statements subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include statements about the results of the company's Vaxfectin(r)-formulated H5N1 influenza DNA vaccine Phase 1 clinical trial and potential future directions for the H5N1 influenza vaccine program. Risks and uncertainties include whether Vical or others will continue development of the H5N1 pandemic influenza vaccines or conduct additional human trials of other Vaxfectin(r)-adjuvanted vaccines; whether the company's H5N1 influenza DNA vaccine will provide durable protection; whether the company's H5N1 influenza DNA vaccine will protect against emerging strains that do not match the vaccine; whether T-cell responses will provide broader protection than antibodies alone; whether H5N1 influenza DNA vaccine Phase 1 clinical trial results will be confirmed in larger studies; whether DNA vaccines against H5N1 influenza or any other targets will be successfully developed and commercialized; whether Vical or its collaborative partners will seek or gain approval to market the influenza vaccine or any other product candidates; whether Vical or its collaborative partners will succeed in marketing any product candidates; whether Vical or others will secure funding to advance the pandemic influenza DNA vaccine program; whether any product candidates will be shown to be safe and efficacious in clinical trials; the timing of clinical trials; whether Vical or its collaborative partners will seek or gain approval to market any product candidates; and additional risks set forth in the company's filings with the Securities and Exchange Commission. These forward-looking statements represent the company's judgment as of the date of this release. The company disclaims, however, any intent or obligation to update these forward-looking statements.
CONTACT: Vical Incorporated