SAN DIEGO, Dec. 11, 2014 (GLOBE NEWSWIRE) -- Vical Incorporated (Nasdaq:VICL) today announced the completion of enrollment in a Phase 1/2 trial of its Vaxfectin®-formulated therapeutic vaccine for herpes simplex virus type 2 (HSV-2), the predominant cause of recurrent genital herpes. The enrollment was completed on schedule as originally planned. The randomized, double-blind, placebo-controlled trial will evaluate safety, tolerability and efficacy of two vaccine candidates (one encoding glycoprotein D alone and the other in combination with UL46). The study is powered to show at least a 30% decrease in the viral shedding rate following 3 doses of vaccine. A total of 165 otherwise healthy HSV-2- infected patients aged 18 to 50 years were enrolled across seven U.S. trial sites. The Company expects to release efficacy data by the middle of 2015.
"The completion of the enrollment of this trial represents an important milestone for Vical," said Dr. Larry Smith, Vical's Vice President of Vaccine Research. "We are now following these subjects and are pleased with the speed of enrollment at our clinical trial sites. This Phase 1/2 trial is a vital step towards developing a product that is safe, and reduces viral shedding and genital herpes lesions."
"A therapeutic vaccine is an important and promising new approach for reducing viral shedding because of its potential ability to bolster the immune system to control HSV-2," said Dr. Anna Wald, a Professor of Allergy and Infectious Diseases at the University of Washington and Fred Hutchinson Cancer Research Center and the Principal Investigator of the Phase 1/2 trial. "Genital herpes is a prevalent and chronic infection. A therapeutic vaccine option has the potential to enhance quality of life by freeing patients from daily, lifelong antiviral drug usage. I look forward to the completion of the trial and reviewing the results in 2015."
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 with HSV-2. HSV-2 infections are persistent and can result in genital lesions, as well as periodic virus shedding placing sexual partners at risk of infection. The presence of HSV-2 genital lesions also significantly increases the risk of acquiring HIV-1 from HIV-infected sexual partners. There is no FDA approved vaccine for HSV-2.
Vical researches and develops biopharmaceutical products leveraging its patented DNA delivery technologies for the prevention and treatment of chronic or life-threatening infectious diseases. In addition, the company has collaborations with major pharmaceutical and biotechnology companies focused on addressing 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 therapeutic HSV-2 vaccine, the parameters of the Phase 1/2 trial and timing regarding results from 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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