Agenus: Genital Herpes Vaccine Meets Primary Endpoint In Phase 2 Trial

(RTTNews) - Agenus Inc. (AGEN) on Thursday announced statistically significant top-line results from its Phase 2 randomized, double-blind, multi-center study for HerpV, a recombinant "off-the-shelf" therapeutic vaccine candidate for the treatment of patients with herpes simplex virus-2 or HSV-2. HerpV contains a defined mixture of peptides representing HSV-2 antigens plus Agenus' QS-21 Stimulon adjuvant.

The company said that the Phase 2 study tested the biological efficacy of HerpV measuring genital viral shedding 45 days before and after three injections of HerpV. The primary analysis, which looked at viral shedding after the initial three injections, shows that subjects who received HerpV had a statistically significant reduction in viral shedding (P=0.015; RR=0.85).

The results suggest a 15% reduction in viral shedding after the initial treatment period before the administration of the booster injection. The results also demonstrate a reduction in viral load of 34% (P=0.08). Placebo patients showed no reduction compared to baseline in either parameter. Notably, patients were not on any antiviral treatments during their swabbing period. The initial data support that vaccination with HerpV has a real, measurable biological effect lowering the active shedding of the virus, the company said.

The company stated that the majority of subjects in the study have received a booster injection of HerpV that was given six months after the first vaccination followed by determination of genital viral shedding for an additional 45-day period. Post-booster viral shedding results, along with immune response data, are anticipated in the first half of 2014.