Transport initiates cold sore trial

The cream will be administered using Transport’s drug-delivery system. The herpes product delivers acyclovir, an approved treatment for cold sores, directly to impacted skin at concentrations up to 40 times higher than topical formulations. The treatment, which has already been proved effective in reducing cold sore healing time, will be tested against placebo and a conventional formulation that requires multiple applications.

Transport’s platform is based on iontophoresis, a technology employing a low-voltage electrical charge to increase skin permeability in order to locally deliver medication through the skin. The company has developed a small, wireless electrode and medication applicators that will allow patients to self-administer topical drugs for a variety of indications.

This multi-centered trial will test Transport’s device/drug combination product in patients with recurrent herpes labialis lesions (cold sores). The trial’s primary endpoint measures the duration of the herpes lesions. The study also has several secondary endpoints, one of which will measure the treatment’s ability to prevent full-blown lesions from occurring.

Enrollment is currently open; 1,800 patients are expected to be recruited through the 24 clinical sites opened in the US. The company anticipates completing treatment in 2006.

“The study is designed to demonstrate superiority over the current topical antiviral standard of care,” said Dr Dennis Goldberg, president and CEO of Transport. “The initiation of this phase III study positions us to expand our business development efforts for this indication and find a partner in the US to market and sell our system.”