SAN DIEGO, Dec. 17, 2013 (GLOBE NEWSWIRE) -- Vical Incorporated (Nasdaq:VICL) today announced the initiation of its Phase 1/2 trial of the company's Vaxfectin™-formulated therapeutic vaccine for herpes simplex virus type 2 (HSV-2), a cause of genital herpes, in approximately 156 subjects. The randomized, double-blind, placebo-controlled trial will evaluate safety, tolerability and efficacy in otherwise healthy HSV-2- infected patients aged 18 to 50 years at six key U.S. clinical sites.
"The initiation of this trial represents another milestone for Vical," said Larry Smith, Vical's Vice President of Vaccine Research. "Our trial is designed to demonstrate reductions in the rate of HSV-2 that is shed from individuals with symptomatic genital herpes. A therapeutic vaccine may be the ideal approach for reducing viral shedding because of the ability to harness the immune system to control HSV-2, potentially freeing subjects from daily, lifelong antiviral drug usage. This Phase 1/2 trial is a vital step towards developing a product that not only limits viral shedding but may also reduce both symptomatic genital herpes lesions as well as virus transmission."
HSV-2 is a sexually transmitted virus which is the leading cause of recurrent genital herpes. Approximately one out of every six individuals aged 15 to 49 years worldwide is chronically infected by HSV-2 virus. HSV-2 infections are persistent and can result in debilitating genital lesions, as well as periodic virus shedding placing sexual partners at risk of infection. The presence of HSV-2 genital lesions significantly increases the risk of acquiring the HIV-1 virus from HIV-infected sexual partners. There is no approved vaccine for HSV-2.
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 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.
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 potential uses and benefits of Vical's vaccine against HSV-2 and the parameters of the Phase 1/2 trial. Risks and uncertainties include whether Vical's technology will be successfully applied; whether preclinical results will be predictive of results in human clinical testing; whether the HSV-2 vaccine or any product candidates will be shown to be safe and effective in clinical trials; whether the Phase 1/2 trial of Vical's HSV-2 vaccine will proceed on Vical's expected timing or be completed, and if so, whether results will support further development or commercialization; whether Vical will successfully develop and commercialize its 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.
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