FRAMINGHAM, Mass., Aug. 15 /PRNewswire/ -- Published today in the peer-reviewed journal Clinical Infectious Diseases, as a major article, are statistically significant Phase IIb clinical results of Transport Pharmaceuticals' first-generation drug/device combination product, SoloVir(TM), for herpes labialis, or cold sores. (Topical Iontophoretic Administration of Acyclovir for the Episodic Treatment of Herpes Labialis: A Randomized, Double-Blind, Placebo-Controlled, Clinic-Initiated Trial, V. 43, p. 460)
The results of this proof-of-concept Phase IIb trial demonstrated a one and a half day (or 35 hours) reduction in the intent-to-treat population median time to healing in the active treatment group as compared to the placebo group (113 hours versus 148 hours; p= 0.02). And, for the subgroup patients that were treated at the first visible stage of infection (erythema stage), the difference in healing time between groups was three days (or 71 hours; 49 hours versus 120 hours; p= 0.03). This trial also demonstrated that the drug/device combination was safe and well-tolerated, with total incidences of adverse events reported similar to placebo.
About the Phase IIb Clinical Trial
The Phase IIb trial was designed as a multi-center, randomized, double-blind, placebo-controlled, clinic initiated, proof-of-concept trial to evaluate the safety and efficacy of a single ten minute iontophoretic application of five percent acyclovir cream for the episodic treatment of cold sores at specified stages of infection. The trial studied 200 non-immunocompromised patients with histories of recurrent cold sore outbreaks (3 or more annually) that were aged 18-75 years.
Cold sore lesions were assessed based on physical presentation (swelling, ulcer, crusting, etc.) and scored by an investigator or trained designee prior to dosing and then daily for 10 days at varying stages. The main determining factor for efficacy was time to healing of classic lesions, defined as the time from the beginning of treatment until there was a loss of crust over the sore.
Spotswood Spruance, MD, co-author, Principal Investigator of the study and Professor of Internal Medicine, at the School of Medicine, University of Utah commented, "In the treatment of herpes labialis, there is a real market need for new, innovative patient-friendly products that penetrate the basal epidermis, provide improved efficacy over existing topical treatments, and decrease the healing time. The drug efficacy in this study is particularly noteworthy, given that this was a clinic-initiated study in which patients did not administer treatment until there was visible evidence of a lesion."
Eric M. Morrel, Ph.D., Vice President Clinical Research of Transport and co-author added, "Past and recent studies have shown that a brief, early window of therapeutic opportunity may exist to treat herpes labialis, so achieving a high level of antiviral drug in the infected tissue, early in the episode of infection, is believed to be both critical and sufficient in realizing the efficacy of antiviral chemotherapy. Our results with a single, iontophoretic antiviral treatment provide further evidence for this dosing strategy. We will investigate the application of the second-generation drug/device combination in additional Phase II trials."
Dennis I. Goldberg, Ph.D., President and Chief Executive Officer of Transport and co-author added, "The strong results of this Phase IIb proof-of- concept study and an earlier clinical study are the basis for advancing Transport's lead product, SoloVir(TM), forward into the clinic."
Dr. Goldberg continued, "Our low voltage, wireless, handheld, reusable portable computer-controlled iontophoretic applicator device has been optimized to allow rapid self-administration of a novel formulation of acyclovir designed for electrokinetic delivery. Our latest proprietary, highly concentrated and soluble acyclovir formulation presents the opportunity to substantially improve efficacy, safety and convenience compared with topical acyclovir. We look forward to conducting additional Phase II trials in the next twelve months."
About Transport's Iontophoresis Delivery Platform
Transport's drug/delivery platform is based on the combination of iontophoresis, a technology employing a low-voltage electrical charge to locally deliver larger amounts of medications through the skin, and proprietary drug formulations optimized for electrokinetic delivery. The Company has developed a small, wireless microprocessor-controlled drug delivery device and pre-filled drug reservoir cartridges that will allow patients to self-administer topical drugs for a variety of indications. The system consists of a reusable control unit and disposable, single-use medicated cartridges. The pre-filled cartridges contain a single unit dose of drug optimized for electrokinetic delivery.
To date, Transport has clinically validated its technology in several US clinical trials in more than 750 patients using the company's first-generation iontophoretic device and an approved topical acyclovir formulation.
About Herpes Labialis
Approximately 20-40 percent of the adult population experience recurrent outbreaks of herpes labialis, or cold sores. Currently approved treatments for herpes labialis are acyclovir cream, penciclovir cream, n-docosonal 10 percent cream, and the oral prodrug of acyclovir, valacyclovir. Multiple studies of acyclovir have suggested that the nominal efficacy of the topical formulation as it is currently marketed is the result of inadequate penetration of the drug into the target site of infection, the basal epidermis layer of the skin.
About Transport Pharmaceuticals, Inc.
Massachusetts-based Transport Pharmaceuticals, Inc. is a privately-held venture back company. To date, the Company has raised US $35.6 million in venture financing. Current venture investors include Quaker BioVentures, The Carlyle Group, The Hillman Company, The Halleran Company and EGS Healthcare. For more information, please visit www.transportpharma.com.
Transport Pharmaceuticals, Inc.