SAN DIEGO, April 3, 2008 /PRNewswire-FirstCall/ -- Vical Incorporated (Nasdaq: VICL) today announced that it has been awarded a two-year, $2.0 million Phase II Small Business Technology Transfer (STTR) grant from the U.S. National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH), an agency of the U.S. Department of Health and Human Services. The grant will fund the ongoing development of Vical's immunotherapeutic plasmid DNA (pDNA) vaccine against herpes simplex virus type 2 (HSV-2), a sexually transmitted virus which is the leading cause of genital herpes. The HSV-2 vaccine will also be evaluated with Vical's novel Vaxfectin(R) adjuvant.
The initial preclinical development activities covered by the grant will be conducted at the University of Washington School of Medicine and the University of Texas Medical Branch, both centers of excellence in herpes virus research. The vaccine will be designed for use in people already infected with HSV-2, with the goal of reducing or eliminating periodic viral flare-ups and the associated viral shedding and transmission.
"HSV-2 infection is an important medical need affecting quality of life for tens of millions of people worldwide," said Vijay B. Samant, Vical's President and Chief Executive Officer. "Chronic antiviral treatment carries a significant healthcare cost and contributes to the emergence of drug-resistant strains and increasing infection rates. A therapeutic vaccine that could control disease symptoms and transmission would be a welcome addition to the HSV-2 treatment arsenal. We are pleased to collaborate with leading academic research centers in addressing this critical public health need."
David Koelle, M.D., professor of medicine in the Division of Allergy and Infectious Diseases at the University of Washington School of Medicine, will lead the mouse research phase of the grant. He said, "I believe that technologies such as pDNA vaccines, which can contribute to priming and boosting CD8 T-cell responses to HSV-2, have the best chance of changing the natural history of established HSV-2 infection, potentially improving symptoms, lesions, shedding, and perhaps even transmission."
The $2.0 million Phase II STTR grant supplements the $0.3 million awarded to Vical in 2005 for the HSV-2 vaccine program under a Phase I STTR grant from the NIAID, which partially funded Vical's initial development of the HSV-2 vaccine.
HSV-2 is a member of the herpesvirus family, and is the leading cause of genital herpes worldwide. In the United States, HSV-2 infects some 1.6 million people per year, with approximately 500,000 of those suffering from disease symptoms. At least 40 million people in the United States are infected with HSV-2. Even higher infection rates are evident in developing countries, with further complications in people also infected with HIV. All HSV-2 infections are permanent and result in periodic virus shedding.
There is currently no approved vaccine for HSV-2. Although antiviral regimens have become a standard of care, their inconvenience, cumulative cost over the years and potential for drug resistance further underscore the need for safe, new approaches to reducing HSV-2 lesions, shedding, and transmission.
Estimated costs of treating HSV-2 in the United States alone are close to $1 billion, primarily for drugs and outpatient medical care. Additional indirect costs from HSV-2 infection, such as lost work hours, are more than $200 million annually in the United States.
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 http://www.vical.com.
This press release contains forward-looking statements subject to risks and uncertainties that could cause actual results to differ materially from those projected, including: whether all funding under the grant will be received by the company; whether the development efforts will result in a vaccine that can generate T-cell and antibody immune responses sufficient to reduce or eliminate periodic viral flare-ups and the associated viral shedding and transmission; whether the Vaxfectin(R) adjuvant will effectively enhance the performance of the HSV-2 vaccine; 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: Alan R. Engbring
|SOURCE Vical Incorporated|
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