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Agenus issued results of a phase II study of HerpV for treatment of genital Herpes Simplex Virus-2 (HSV-2). The randomized, double-blind, multi-center study enrolled 80 subjects with a history of one to nine herpes recurrences within the prior 12 months. 70 subjects received the active treatment, HerpV and QS-21 Stimulon, and 10 subjects received placebo. Three injections of HerpV at a dose of 240μg (includes12μg of a mix of 32 different HSV-2 antigenic peptides) or placebo were given at two week intervals. HSV-2 activity in the genito-urinary tract was monitored by PCR for HSV-2 DNA in genital swabs for 45 days before and after the initial course of three vaccinations. The primary analysis, which looked at viral shedding after the initial three HerpV vaccinations, demonstrated that subjects who received HerpV had a statistically significant reduction in viral shedding (P=0.015; RR=0.85). 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. More than half of those vaccinated developed a robust anti-HSV cytotoxic T-cell immune response, and in those patients there was a statistically significant 75% reduction in viral load (P<0.001; CI: 46.2—88.6%). After the booster shot, HerpV demonstrated a durable reduction in viral shedding approximating 14% (RR=0.86 and CIs: 0.58-1.26) and remains consistent with the reduction in viral shedding observed duing the initial treatment period.
Transport reported positive results from a phase II trial of SoloVir for the treatment of Herpes labialis. This randomized, double blind, placebo-controlled trial, dubbed TPI-H-221, enrolled two hundred and sixty subjects. The subjects were randomized in a 1:1:1 ratio into one of three treatment groups: treatment with SoloVir gel followed by treatment with placebo gel; treatment with placebo gel followed by treatment with SoloVir gel; or treatment with placebo gel followed by treatment with placebo gel. Treatment was self administered at the first signs and symptoms of a herpatic lesion. The treatment phase ended after eighty subjects in each group had herpatic recurrence and received treatment. Data indicated that treatment at this early stage resulted in a statistically significant effect on the herpetic episode. The SoloVir treated groups showed a 79% increase in aborted lesions over placebo (43% active; 24% placebo; p= 0.03). The subjects receiving SoloVir also experienced a 3.5 day reduction in time to complete healing (p= 0.015). Treatment was well tolerated, with no reported serious adverse events. Based on the results, Transport plans to initiate the next stage of development in 2008.