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
transportpharma.
Transport Pharmaceuticals, Inc.
transportpharma
View drug information on Acyclovir Capsules.