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Agenus' HerpV Phase 2 Study To Treat Genital Herpes Completes Enrollment

  • HerpV is clinically the most advanced therapeutic vaccine for the treatment of genital herpes
  • HerpV contains Agenus' QS-21 Stimulon ®* adjuvant currently being studied in 17 other clinical programs

LEXINGTON, Mass., Feb. 27, 2013 (GLOBE NEWSWIRE) -- Agenus Inc. (Nasdaq:AGEN), a developer of therapeutic vaccines for cancer and infectious diseases, today announced it has completed patient screening in its Phase 2 randomized, double-blind, multicenter study for HerpV, a recombinant "off-the-shelf" therapeutic vaccine candidate for the treatment of genital herpes in herpes simplex virus-2 (HSV-2) positive patients. HerpV contains Agenus' QS-21 Stimulon ® adjuvant (QS-21 Stimulon).

The Phase 2 study (designated as protocol C-400-02) has screened over 100 HSV-2 positive subjects and enrollment has been closed. The study will test the biological efficacy of HerpV as measured by effect on genital viral shedding after three injections of the therapeutic vaccine. A booster injection of HerpV will be given at six months after treatment to evaluate the potential durability of treatment effect.

The HerpV Phase 2 study has been supported by leading clinical experts in the field who have expressed that a reduction in viral shedding could translate into clinical benefit. A therapeutic vaccine to treat HSV-2 infected patients has the potential to provide a major paradigm shift in the treatment of this infection as well as provide significant quality of life benefits.

Agenus' QS-21 Stimulon is a novel adjuvant that is incorporated into 17 vaccines currently in clinical development, including four GlaxoSmithKline (GSK) Phase 3 programs. Results from GSK's Phase 3 trials using MAGE-A3 cancer immunotherapeutic vaccines in lung cancer and melanoma, which incorporate QS-21 Stimulon, are anticipated this year. 

About Heat Shock Protein Platform (HSP) and Recombinant Series HerpV                                                                                                          

HerpV is a recombinant therapeutic vaccine for the treatment of genital herpes, which is caused by the herpes simplex virus-2 (HSV-2). The vaccine is based on Agenus' HSP platform technology, and contains Agenus' proprietary QS-21 Stimulon. HerpV consists of recombinant human heat shock protein-70 complexed with 32 distinct 35-mer synthetic peptides from the HSV-2 proteome. This broad spectrum of herpes antigens is intended to allow for more accurate immune targeting and surveillance, reducing the likelihood of immune escape. Further, the diversity of antigens in HerpV increases the chance of providing efficacy for a wide segment of the patient population.

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