Transport Delivers Unprecedented Levels Of Acyclovir With Novel Five Percent Gel Formulation
Transport Pharmaceuticals, Inc., a leader in combination drug/medical devices for the topical treatment of dermatological conditions, today announced preliminary results from a recently completed Phase I safety and pharmacokinetic study with the SoloVir(TM) electrokinetic transdermal system, being developed for the treatment of herpes labialis, or cold sores. The TPI-H-111 study, which was conducted in 32 normal volunteers, was the first clinical application of the new SoloVir(TM) combination product featuring single-use drug cartridges containing Transport's novel, five-percent acyclovir gel formulation. Although treatment of a herpetic episode with the SoloVir(TM) system will consist of a single ten minute treatment, each subject received four treatments over the course of two days in this study designed to assess safety and pharmacokinetics.
The four treatments were very well tolerated by all subjects, with no significant skin irritation and few, mild adverse events. In addition, the portable, ergonomically designed devices were easily used by all subjects and performed as specified during 128 uses.
Eric M. Morrel, Ph.D., Vice President of Clinical Research at Transport commented on the data, "The pharmacokinetic data indicate that a single ten minute application delivered approximately 40 micrograms of acyclovir to the circulation after passing through stratum corneum and locally depositing in the epidermis. Although 40 micrograms does not appear to be a high dose, we are achieving concentrations of at least 200 ug/ml at the site of infection due to the small initial volume of distribution in the skin. That means, based on published reports, we are realizing local delivery of about 100 times the peak tissue level of the 2 ug/ml achieved with a 1 gram dose of Valtrex(R), a leading oral-antiviral drug marketed for the treatment of herpes labialis."
Dr. Morrel continued, "In addition, the peak tissue levels for acyclovir are achieved at the time of administration with SoloVir(TM), while orally administered Valtrex(R) requires more than two hours to reach peak acyclovir levels in the skin."
"I have long believed that the delivery of a large bolus of anti-viral drug into the skin at the onset of first signs and symptoms is required to prevent tissue damage during a herpetic episode," said Spotswood Spruance, M.D., Professor of Medicine in the Departments of Internal Medicine and Dermatology at the University of Utah School of Medicine, a noted herpes labialis expert and advisor to Transport. "These data indicate that the SoloVir(TM) system may actually be able to achieve that goal."
"These are very exciting results," said Dennis Goldberg, Ph.D., President and Chief Executive Officer of Transport. "The concept behind the SoloVir(TM) system, and the other product development programs in Transport's pipeline, is delivery of a large bolus of drug directly to the affected tissue in a simple, painless, convenient, patient-friendly manner. The TPI-H-111 outcome, which was the first clinical application of our new control unit design and our proprietary five-percent acyclovir gel, indicates that we have accomplished that goal. We are looking forward to commencing TPI-H-211, our double blind, placebo-controlled Phase II study in subjects with recurrent herpes labialis, in the second quarter of 2007."
About SoloVir(TM)
Transport's lead product, the SoloVir(TM) electrokinetic transdermal system, utilizes the company's proprietary five-percent acyclovir gel- formulation that has been optimized for delivery via its electrokinetic transdermal device. If successful, the SoloVir(TM) system could dramatically change the treatment options for people who suffer from herpes labialis. SoloVir(TM) is designed to substantially improve efficacy, safety and convenience compared with the marketed topical acyclovir cream and oral antiviral drugs, which are sold by prescription in the US. SoloVir(TM) achieves unprecedented concentrations of acyclovir in impacted skin areas.
About Transport Pharmaceuticals, Inc.
Massachusetts-based Transport Pharmaceuticals, Inc. is a privately-held specialty pharmaceutical company bringing together cutting-edge medical electronics with drug formulation and materials science to develop drug/device combination products. Transport has created a series of unique, microprocessor-controlled iontophoretic devices that enhance movement of drugs across the stratum corneum (the skin's outer layer) by means of electric current. Transport's platform technology has wide applications and the company is creating a robust pipeline of targeted products for the topical treatment of dermatological conditions. To date, the Company has raised $35.6 million in venture financing. Current venture investors include Quaker BioVentures, The Carlyle Group, The Hillman Company and The Halleran Company. For more information, please visit http://www.transportpharma.com.
Transport Pharmaceuticals, Inc.
http://www.transportpharma.com
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