SAN DIEGO, April 27, 2010 (GLOBE NEWSWIRE) -- Vical Incorporated (Nasdaq:VICL) announced today that a prime-boost malaria vaccine regimen provided sterile protection, with no disease symptoms and no detectable malaria parasites, in 4 of 15 vaccinated volunteers a full 28 days after challenge with multiple infected-mosquito bites. The remaining 11 vaccinated volunteers and all 6 unvaccinated control volunteers developed parasitic infections. Results were presented at the National Foundation for Infectious Diseases (NFID) Thirteenth Annual Conference on Vaccine Research (Bethesda - April 26-28).
The Phase 1/2a clinical trial evaluated a prime-boost vaccine regimen combining three doses of unadjuvanted two-gene malaria DNA vaccine based on Vical's DNA delivery technology followed by a single dose of a corresponding two-gene viral-vector malaria vaccine. All volunteers were malaria-naive. The vaccines were well-tolerated, and there were no vaccine-related serious adverse reactions. While there was no relationship to antibody titers, three of the four protected volunteers had strong T-cell immune responses to one or both of the encoded malaria antigens. The trial was conducted through the U.S. Military Malaria Vaccine Program, with the participation of the Naval Medical Research Center (NMRC) and the Walter Reed Army Institute of Research, and with financial support from the U.S. Agency for International Development, the Congressionally Directed Medical Research Program and the Military Infectious Diseases Research Program.
Preclinical Vaxfectin® Results
Separate preclinical malaria vaccine studies, conducted by NMRC, demonstrated that Vical's Vaxfectin® adjuvant enhanced both antibody and T-cell immune responses to each component of a low-dose, five-gene malaria DNA vaccine. Results were published in the journal Vaccine1, and support use of the Vaxfectin® adjuvant in vaccines against complex pathogens such as malaria, in which multiple vaccine components are needed to afford broad protection.
Vical provided the DNA vaccines for the clinical program as well as the Vaxfectin® adjuvant for the preclinical program.
About Vical
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 Vical's DNA delivery and Vaxfectin® adjuvant technologies, the two-gene and five-gene malaria vaccines, as well as the company's focus, collaborative partners, and independent and partnered product candidates. Risks and uncertainties include whether Vical or others will continue development of malaria DNA vaccines or any other product candidates; whether T-cell and/or antibody immune responses will effectively prevent malaria parasite infection; whether the Vaxfectin® adjuvant will be used in vaccines against malaria or other complex pathogens; whether Vaxfectin®-adjuvanted, multi-component vaccines will provide protection against the target pathogens; whether Vical or others will seek or gain approval to market a DNA-based malaria vaccine or any other product candidates; whether Vical or others will succeed in marketing 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.
1Sedegah M et al. Vaxfectin® enhances both antibody and in vitro T cell responses to each component of a 5-gene Plasmodium falciparum plasmid DNA vaccine mixture administered at low doses. Vaccine 2010; 28:3055-3065.