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Press Release - Vical Incorporated (VICL-NASDAQ)

“We can apply our technology for vaccines; we can apply it for proteins, animal health applications, cancer. We are focusing on vaccines because vaccines are now probably the single most important medical advance that is going to be required in the next fifty years to deal with a variety of diseases as well as a variety of cancers. We are focused on one of the most lucrative applications of this technology.” - Vijay B. Samant (VICL) (Interview published February 15, 2007)

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Vical Begins Phase 1 Trial of DNA Vaccine Against H1N1 Pandemic Influenza

SAN DIEGO, May 5, 2010 (GLOBE NEWSWIRE) -- Vical Incorporated (Nasdaq:VICL) today announced the enrollment of the first subject in its Phase 1 trial of the company's Vaxfectin®-formulated plasmid DNA (pDNA) pandemic influenza vaccine. The trial will be conducted in collaboration with the U.S. Naval Medical Research Center (NMRC).

"The H1N1 outbreaks in 2009 served as a wake-up call highlighting the need for more responsive vaccine technologies," said Vijay B. Samant, Vical's President and Chief Executive Officer. "Future pandemics are inevitable, and could become more frequent with increasingly crowded living conditions in developing countries coupled with more widespread international travel. Through our ongoing collaboration with the U.S. government, we are leveraging the success of our H5N1 influenza vaccine trials toward establishing Vical's DNA vaccine platform to address future emerging infectious disease threats."

Vical's vaccine contains plasmid DNA encoding a hemagglutinin (HA) surface protein from the H1N1 influenza virus strain, A/California/04/09. The vaccine is formulated with the company's Vaxfectin® adjuvant, which has demonstrated effectiveness with a variety of DNA vaccines in multiple animal models as well as initial human testing in the H5N1 DNA vaccine Phase 1 trial. It has also demonstrated dose-sparing and immune-enhancing ability with a conventional seasonal influenza vaccine in animals.

The double-blind, placebo-controlled H1N1 influenza vaccine Phase 1 trial will enroll approximately 30 healthy adult volunteers at a single U.S. clinical site. Subjects will be randomized 2:1 into the vaccine or placebo arms of the trial. Vaccine will be administered on days 0 and 21, and immunogenicity assessments will continue through the final 6-month follow-up visit.

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.

The Vical Incorporated logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=5768

This press release contains forward-looking statements subject to risks and uncertainties that could cause actual results to differ materially from those projected. Risks and uncertainties include whether Vical will receive all, if any, of the trial funding; whether the funding will be sufficient to complete the Phase 1 trial; whether the trial will enroll the full 30 subjects, if any; whether Vical, NMRC or others will continue development of any pandemic influenza DNA vaccine candidates; whether Vical and/or NMRC will terminate the CRADA before achievement of its objectives; whether the company's DNA vaccine candidate will be effective in inducing protective levels of immunogenicity in humans against H1N1 strains of influenza; whether future pandemics will occur, and if so, whether DNA vaccines will be successfully applied against them; whether the influenza vaccine or any other product candidates will be shown to be safe and effective; the timing, nature and cost of clinical trials; whether Vical or its collaborative partners will seek or gain approval to market any product candidates; whether Vical or its collaborative partners 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.

CONTACT: Vical Incorporated
         Alan R. Engbring
         (858) 646-1127
         www.vical.com

 

			
 
 
 

 

			
 
 
 
 




    

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