SAN DIEGO, March 22, 2010 (GLOBE NEWSWIRE) -- Vical Incorporated (Nasdaq:VICL) announced today that the U.S. Navy, through the Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc., has awarded Vical a contract to conduct a Phase 1 clinical trial of the company's Vaxfectin®-formulated DNA vaccine against A/H1N1 pandemic influenza (swine flu). Vical had previously been awarded a contract by the U.S. Navy, in collaboration with the Transformational Medical Technologies Initiative (TMTI) of the Department of Defense (DoD), to support large-scale cGMP vaccine manufacturing and related clinical and regulatory preparations for the trial, bringing total U.S. government funding for this project to approximately $2 million.
The Investigational New Drug (IND) application describing the trial design had been allowed by the U.S. Food and Drug Administration (FDA) in 2009, so the new funding clears the path for the trial to begin.
"The 2009 outbreaks of H1N1 pandemic influenza provided an excellent opportunity for Vical to demonstrate the speed of our vaccine development approach, particularly in the crucial early weeks," said Vijay B. Samant, Vical's President and Chief Executive Officer. "Our collaborators within the U.S. Navy are focused on developing a more responsive vaccine platform to provide rapid protection for military personnel against future emerging disease threats. The Navy funding of a Phase 1 trial allows us to build on the success of our H5N1 vaccine, expand the safety and immunogenicity database for Vaxfectin®-formulated vaccines in humans, and open the door to broader collaborations with the U.S. government."
As previously announced, Vical was the first company to produce a vaccine against the A/H1N1 influenza virus after the initial reports of widespread outbreaks in Mexico, and the first to announce robust immunogenicity results from animal testing in two species. The company has opted to advance the H1 DNA vaccine, formulated with Vical's patented Vaxfectin® adjuvant, only with continued government funding.
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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About the Transformational Medical Technologies Initiative
The TMTI was created by the DoD to protect the Warfighter from emerging and genetically altered biological threats by discovering and developing a wide range of medical countermeasures through enhanced medical research, development, test and evaluation programs. The TMTI Program Office is matrixed from the Joint Science and Technology Office – Defense Threat Reduction Agency (DTRA) and Joint Program Executive Office – Chemical and Biological Defense, with oversight from the Office of the Secretary of Defense. For more information on TMTI, visit www.tmti-cbdefense.org.
About the Defense Threat Reduction Agency
The Defense Threat Reduction Agency (DTRA) was founded in 1998 to integrate and focus the capabilities of the Department of Defense (DoD) that address the weapons of mass destruction (WMD) threat. The mission of the DTRA is to safeguard America and its allies from WMD (e.g. chemical, biological, radiological, nuclear, and high yield explosives) by providing capabilities to reduce, eliminate, and counter the threat, and mitigate its effects. Under DTRA, Department of Defense resources, expertise and capabilities are combined to ensure the United States remains ready and able to address the present and future WMD threats. For more information on DTRA, visit www.dtra.mil/.
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 a Phase 1 trial; whether Vical or others will continue development of any pandemic influenza DNA vaccine candidates; whether the company's DNA vaccine candidate will be effective in protecting humans against H1N1 strains of influenza; whether future pandemics will arise, 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 in clinical trials; the timing, nature and cost of clinical trials; whether Vical will expand its collaboration with the U.S. government; 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.