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Transport Pharmaceuticals's Phase 2 Data Show Single Treatment SoloVir(TM) ETS Significantly Stops Progression of Cold Sore Episode


11/28/2007 7:03:05 AM

FRAMINGHAM, Mass. and NEW YORK, Nov. 28 /PRNewswire/ -- Today at the 19th Annual Piper Jaffray Health Care Conference, Dr. Dennis I. Goldberg, President and Chief Executive Officer of Transport Pharmaceuticals, Inc., presented compelling clinical results of a Phase 2 study designed to evaluate the safety and efficacy of the company's lead drug/device product, the SoloVir(TM) Electrokinetic Transdermal System (SoloVir(TM) ETS) for recurrent herpes labialis (cold sores). SoloVir(TM) ETS uses single-use drug cartridges containing Transport's novel, five-percent acyclovir gel.

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, i.e. whether treatment at either the prodrome or erythema stage on day one of the herpetic episode was significantly better than placebo. TPI-H-221 was a multi center, randomized, double blind, placebo-controlled study that enrolled approximately 260 subjects.

Dennis I. Goldberg, President and CEO, commented on the clinical results, "The TPI-H-221 study has demonstrated that treatment at the erythema or papule/edema stages, the first visible signs of a cold sore, decreased the number of patients who progressed to classical lesions, and resulted in a dramatic decrease in healing times. Patients who treated earlier, at the prodrome stage, did not see a statistically significance benefit. Our Phase 2 study provides valuable insights into the treatment of herpes labialis. SoloVir(TM) ETS is the only one time treatment to achieve a statistically significant and clinically meaningful decrease in herpetic lesions. This study provides a number of important findings that provide a clear path for completing the development of this novel combination drug/device product."

Spotswood Spruance, MD, a noted expert on herpes labialis and a member of Transport's Scientific Advisory Board, commented, "Based on two well controlled Phase 2 clinical studies, Transport may offer the clinical community a new paradigm for treating herpes more efficaciously by administering treatment to the site of viral replication at the first visible evidence of a lesion."

Dr. Spruance continued, "There has been some controversy in the medical community about treating this patient population during the prodrome stage because as many as one third will have aborted lesions without receiving any treatment. SoloVir(TM) ETS may mitigate that controversy by allowing patients to wait for the first visual signs before initiating treatment, thereby treating patients with a higher probability of progression to classical lesion."

TPI-H-221 Study Results

Data from this Phase 2 clinical study indicate that treatment at the erythema or papule/edema stages resulted in a statistically significant effect on the herpetic episode. In particular, the study demonstrated a 79 percent increase in aborted lesions (43% active; 24% placebo; p= 0.03; active n= 61; placebo n= 72) in SoloVir(TM) ETS treated subjects versus placebo. These subjects also experienced a 3.5 day reduction in time to complete healing (p= 0.015). Furthermore, this study demonstrated a statistically significant and clinically meaningful reduction in pain. SoloVir(TM) ETS was shown to be well tolerated with a compliance rate greater than 98 percent, with no serious adverse events reported related to study drug in all groups.

Based on the strong clinical results from TPI-H-221, Transport will advance SoloVir(TM) ETS into its next clinical stage of development in 2008. Transport has retained worldwide rights to SoloVir(TM) ETS for the treatment of herpes labialis.

TPI-H-221 Study Design

Patients were randomized in a 1:1:1 ratio into one of three iontophoretic treatment groups, two active arms and one placebo arm.

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. Treatment phase ended after at least 80 patients in each treatment group had experienced a herpetic episode and received either drug or placebo treatment. The small size and portability of SoloVir(TM) ETS allowed 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 followed 6 - 18 hours later in the clinic.

About SoloVir(TM) ETS

Transport's lead product, SoloVir(TM) ETS, utilizes the company's proprietary five-percent acyclovir gel formulation to treat herpes labialis, or cold sores. SoloVir(TM) ETS consists of a reusable control unit and a disposable, unit-dose, single-use medicated cartridge. The small, wireless control unit uses a low voltage which is varied in response to patient skin impedance to provide constant current and control of drug delivery. The drug cartridge contains a unit dose of the drug formulation as well as the drug delivery electrode. Portability of the battery-powered device allows patients to easily self-administer topical drugs for a variety of indications. Both product and technology were developed by Transport's scientists and engineers and are protected by a broad patent portfolio.

Pharmacokinetic data from a Phase I study (TPI-H-111) indicate that a single ten minute treatment with SoloVir(TM) ETS delivered more than 100 times the published peak tissue levels (2 ug/ml) of acyclovir achieved with a 1 gram dose of Valtrex(R), 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(TM) ETS, while orally administered Valtrex, requires more than two hours to reach peak acyclovir levels in the skin. Results of an earlier reported, clinic-initiated proof-of-concept study with a prototype device and 5 percent acyclovir cream demonstrated a three day (or 71 hours; 49 hours versus 120 hours; p= .03) reduction in healing time among a subgroup of patients that were treated at the first visible stage of infection or erythema stage. {Clinical Infectious Diseases, August 15, 2006}.

About Herpes Labialis

Herpes labialis, also called cold sores, is caused by the herpes simplex virus, most commonly type I (HSV-1). Up to 90 percent of the U.S. population is infected with HSV-1, and approximately 30 percent suffer from recurring outbreaks. On average, a patient has four cold sore outbreaks per year. As a result, there are an estimated 360 million recurrent herpetic episodes in the U.S. per year. It is second only to the common cold in prevalence. Currently approved treatments for herpes labialis, including acyclovir cream, penciclovir cream, n-docosonal 10 percent cream, valacyclovir, the oral prodrug of acyclovir, and famciclovir, the oral prodrug of penciclovir, are all labeled to treat at the prodromal stage. None of these treatments are proven to increase the frequency of aborted lesions (aborted lesions are those that do not progress to vesicle, or ulcer stages of classical lesions).

About Transport

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. In addition to the lead drug/device product, SoloVir(TM) ETS, Transport has a pipeline of earlier stage dermatological products based on its electrokinesis platform including onychomycosis, acne, actinic keratosis, keloids, warts, psoriasis, skin cancer and medical aesthetic applications.

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.

CONTACT: Corporate, Sean Moran, Chief Financial Officer of Transport
Pharmaceuticals, Inc., +1-508-872-0433, smoran@transportpharma.com; Media,
Bryan Murphy, Director, Public Relations of LaVoie Group, +1-978-745-4200.
ext. 105, bmurphy@lavoiegroup.com, for Transport Pharmaceuticals, Inc.

Web site: http://www.transportpharma.com/



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