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This unique study was designed to determine the optimum treatment protocolbased upon the immediate delivery of a large bolus of acyclovir into the skinduring a herpetic episode, i.e. whether treatment at either the prodrome orerythema stage on day one of the herpetic episode was significantly betterthan placebo. TPI-H-221 was a multi center, randomized, double blind,placebo-controlled study that enrolled approximately 260 subjects.
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Dennis I. Goldberg, President and CEO, commented on the clinical results,"The TPI-H-221 study has demonstrated that treatment at the erythema orpapule/edema stages, the first visible signs of a cold sore, decreased thenumber of patients who progressed to classical lesions, and resulted in adramatic decrease in healing times. Patients who treated earlier, at theprodrome stage, did not see a statistically significance benefit. Our Phase 2study provides valuable insights into the treatment of herpes labialis.SoloVir(TM) ETS is the only one time treatment to achieve a statisticallysignificant and clinically meaningful decrease in herpetic lesions. Thisstudy provides a number of important findings that provide a clear path forcompleting the development of this novel combination drug/device product."
Spotswood Spruance, MD, a noted expert on herpes labialis and a member ofTransport's Scientific Advisory Board, commented, "Based on two wellcontrolled Phase 2 clinical studies, Transport may offer the clinicalcommunity a new paradigm for treating herpes more efficaciously byadministering treatment to the site of viral replication at the first visibleevidence of a lesion."
Dr. Spruance continued, "There has been some controversy in the medicalcommunity about treating this patient population during the prodrome stagebecause as many as one third will have aborted lesions without receiving anytreatment. SoloVir(TM) ETS may mitigate that controversy by allowing patientsto wait for the first visual signs before initiating treatment, therebytreating patients with a higher probability of progression to classicallesion."
TPI-H-221 Study Results
Data from this Phase 2 clinical study indicate that treatment at theerythema or papule/edema stages resulted in a statistically significant effecton the herpetic episode. In particular, the study demonstrated a 79 percentincrease in aborted lesions (43% active; 24% placebo; p= 0.03; active n= 61;placebo n= 72) in SoloVir(TM) ETS treated subjects versus placebo. Thesesubjects also experienced a 3.5 day reduction in time to complete healing (p=0.015). Furthermore, this study demonstrated a statistically significant andclinically meaningful reduction in pain. SoloVir(TM) ETS was shown to be welltolerated with a compliance rate greater than 98 percent, with no seriousadverse events reported related to study drug in all groups.
Based on the strong clinical results from TPI-H-221, Transport willadvance SoloVir(TM) ETS into its next clinical stage of development in 2008.Transport has retained worldwide rights to SoloVir(TM) ETS for the treatmentof herpes labialis.
TPI-H-221 Study Design
Patients were randomized in a 1:1:1 ratio into one of three iontophoretictreatment groups, two active arms and one placebo arm.
Primary efficacy in this patient initiated study of approximately 260su
