Transport Pharmaceuticals Initiates Patient Enrollment In Phase 2 Study Of Solovir System For Herpes Labialis
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- Published on Wednesday, 02 May 2007 04:00
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FRAMINGHAM, MA, USA | May 01, 2007 | Transport Pharmaceuticals, Inc., a leader in combination drug/medical devices for the topical treatment of dermatological conditions, today announced the initiation of patient dosing in clinical protocol TPI-H-221, a multi center, randomized, double blind, placebo-controlled Phase 2 study designed to evaluate the safety and efficacy of the SoloVir™ electrokinetic transdermal system with single-use drug cartridges containing Transport’s novel, five-percent acyclovir gel formulation in patients with recurrent herpes labialis (cold sores).
Dennis Goldberg, Ph.D., President and Chief Executive Officer commented, “The initiation of this Phase 2 study is an important milestone for Transport. We were very encouraged by the pharmacokinetic data from our recently reported Phase 1 study with SoloVir and our novel 5 percent acyclovir gel and we look forward to completing this Phase 2 study and releasing those results. The unique study design will allow us to determine whether treatment at either first signs and symptoms, or treatment at a later stage, is significantly better than placebo.”
Primary efficacy in this patient initiated study of more than 240 subjects will be measured by clinician assessed duration of the herpetic episode and safety will be assessed by adverse events. Prevention of progression to classical lesions is a key secondary endpoint. After enrollment, all patients will be randomized into one of three iontophoretic treatment groups: two active treatment arms and one placebo treatment arm. The treatment phase will end after 80 patients in each treatment group have suffered a herpetic recurrence and received treatment. SoloVir, with pre-loaded drug cartridges containing a proprietary five-percent acyclovir gel formulation, will be employed in this study. The small size and portability of SoloVir will allow patients to treat themselves immediately at the first signs and symptoms of a herpetic lesion with a single, ten minute iontophoretic application of either active acyclovir gel or placebo gel. A second, investigator-supervised treatment will follow 6 – 18 hours later in the clinic.
Patients will be randomized in a 1:1:1 ratio into one of three treatment groups: treatment with active gel followed by treatment with placebo gel; treatment with placebo gel followed by treatment with active gel; or treatment with placebo gel followed by treatment with placebo gel.
Transport’s lead product, the SoloVir electrokinetic transdermal system, utilizes the company’s proprietary five-percent acyclovir gel formulation to treat herpes labialis, or cold sores. Pharmacokinetic data from a recently completed Phase I study (TPI-H-111) indicate that a single ten minute treatment with SoloVir delivered more than 100 times the published peak tissue levels (2 ug/ml) of acyclovir achieved with a 1 gram dose of Valtrex®, a leading oral-antiviral drug marketed for the treatment of herpes labialis. In addition, the peak tissue levels are achieved at the time of administration with SoloVir, while orally administered Valtrex, requires more than two hours to reach peak acyclovir levels in the skin.
Transport is bringing together cutting-edge medical electronics with drug formulation and material sciences to develop drug/device combination products that enhance movement of drugs across the stratum corneum (the skin’s outer layer) by means of electric current.
Transport is a Massachusetts-based, privately-held specialty pharmaceutical company. Current venture investors include Quaker BioVentures, The Carlyle Group, The Hillman Company and The Halleran Company. For more information, please visit www.transportpharma.com.
SOURCE: Transport Pharmaceuticals, Inc