Vical Completes Enrollment In Its Therapeutic HSV-2 Vaccine Clinical Trial

Vical Incorporated

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.