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Clinical Trials Resource Center

New Medical Therapies™

Herpes Simplex Infections

December 3, 2007

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.


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