TPI-H-221 was a multi-center, randomized, double-blind, placebo-controlled study that enrolled approximately 260 subjects. This unique study was designed to determine the optimum treatment protocol based upon the immediate delivery of a large bolus of acyclovir into the skin during a herpetic episode.
Data from this Phase II clinical study indicate that treatment at the erythema or edema stages resulted in a statistically significant effect on the herpetic episode. In particular, the study demonstrated a 79% increase in aborted lesions (43% active; 24% placebo) in SoloVir ETS treated subjects versus placebo. These subjects also experienced a 3.5 day reduction in time to complete healing. Furthermore, this study demonstrated a statistically significant and clinically meaningful reduction in pain.
SoloVir ETS was shown to be well tolerated, with a compliance rate greater than 98%, with no serious adverse events reported related to study drug in all groups. Primary efficacy in this patient initiated study of approximately 260 subjects was measured by duration of the herpetic episode. Prevention of progression to classical lesion, time to complete healing, and duration of pain were key secondary endpoints.
Based on the strong clinical results from TPI-H-221, Transport will advance SoloVir ETS into its next clinical stage of development in 2008. Transport has retained worldwide rights to SoloVir ETS for the treatment of herpes labialis.
Dennis Goldberg, president and CEO of Transport Pharmaceuticals, said: “Our Phase II study provides valuable insights into the treatment of herpes labialis. SoloVir ETS is the only one time treatment to achieve a statistically significant and clinically meaningful decrease in herpetic lesions.”