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HerpV is the most clinically advanced therapeutic vaccine candidate for the treatment of genital herpes
Contains Agenus' QS-21 Stimulon ® adjuvant currently being studied in 17 clinical programs
LEXINGTON, Mass., Oct. 23, 2012 (GLOBE NEWSWIRE) -- Agenus Inc. (Nasdaq:AGEN), a developer of therapeutic vaccines for cancer and infectious diseases, today announced that it has initiated a Phase 2 randomized, double-blind, multicenter study of HerpV, a recombinant "off-the-shelf" therapeutic vaccine candidate for the treatment of genital herpes in Herpes Simplex Virus 2 (HSV-2) positive subjects. HerpV contains Agenus' QS-21 Stimulon
®* adjuvant, which is currently being studied in 17 additional clinical programs.
The study designated as protocol C-400-02 will enroll 75 HSV-2 positive subjects who have a history of frequent disease recurrences. The study will test the efficacy of the HerpV vaccine as measured by effect on genital viral shedding. In the study, 65 participants will receive the active treatment, HerpV and QS-21, and a control group of 10 participants will receive placebo. A booster injection will be given at six months after treatment to evaluate the durability of treatment effect.
The HerpV Phase 2 study design has been defined by key opinion leaders in the field. Experts in HSV-2 clinical research believe that a reduction in viral shedding, the driving force behind the spread of genital herpes, is an important surrogate for clinical benefit in potentially reducing recurrent outbreaks.
"Our earlier clinical experience demonstrated an unprecedented immune response with both arms of the immune system (CD8+ and CD4+ T cells) being activated in subjects vaccinated with HerpV and QS-21, but not in subjects receiving placebo," said Garo H. Armen, Ph.D., chairman and CEO of Agenus Inc. "Incorporating a broad spectrum of herpes antigens along with QS-21 has the potential enable the immune system's ability to recognize and destroy HSV-2 infected cells."