FDA approves Beech Tree Labs' IND for Phase 1/2a clinical evaluation of BTL-TML-HSV

Beech Tree Labs, Inc., announced today that the FDA has approved its IND for a Phase 1/2a clinical evaluation of BTL-TML-HSV, a novel therapeutic agent for treating recurrent oral herpes infections. The study will be a 210 patient, multi-site, placebo-controlled trial and is anticipated to begin later this summer.

According to WHO and CDC statistics, over 80 percent of the population have oral herpes with about 20 percent of these expressing symptoms. One if four adults has genital herpes, with the incidence steadily increasing.

Herpes simplex, the virus causing oral herpes, serves as the prototype of a Beech Tree Labs' approach that potentially addresses a broad spectrum of herpesvirus indications. The active agent is also embodied in a product candidate that recently received FDA approval of an IND targeting influenza, presenting evidence of a growing Beech Tree anti-viral platform.