PROVIDENCE, R.I., April 4, 2013 (GLOBE NEWSWIRE) -- Beech Tree Labs, Inc. announced today that it has completed a Phase 1/2a clinical evaluation of its novel therapeutic agent, BTL-TML-HSV, for treating recurrent symptomatic oral herpes virus infection following a dental procedure. This study was a multi-site, 171-subject, randomized, placebo-controlled trial.
All subjects were given study medication and instructed to begin dosing immediately upon experiencing prodromal symptoms of tingling, burning, itching, or presence of a lesion. Of the 171 intent-to-treat patients, 31 progressed to prodrome, and initiated therapy with either BTL-TML-HSV or the vehicle control. Improved blocking of progression of the episode from prodrome to the lesion stage was the primary endpoint of the study.
BTL-TML-HSV was well-tolerated, with no differences in adverse events apparent between subjects in the two groups. The proportion of subjects receiving the vehicle control that progressed to lesion was 77.8 percent (7/9 subjects) while the proportion receiving BTL-TML-HSV that progressed to lesion was 45.5 percent (10/22 subjects). This difference trended toward but did not reach statistical significance (p=0.1). The low number of subjects randomized into the vehicle control group that eventually developed symptoms of prodrome contributed in large part to the trending of the data toward, rather than reaching, statistical significance.
Beech Tree's founder and CEO, Dr. John McMichael said, "The results from this clinical trial combined with our in vitro mechanism-of-action work, intellectual property position, and confidence that this product is active against other herpesviruses is the impetus for aggressively moving BTL-TML forward to out-licensing and eventual commercialization."
According to WHO and CDC, over 80 percent of the world population has oral herpes with about 20 percent of these expressing symptoms. Treatment options are limited.
About Beech Tree Labs, Inc.
Beech Tree is a leader in molecular signaling technology with an extensive patent portfolio that includes other therapeutics targeting a broad spectrum of chronic disorders. The Company is a privately held biopharmaceutical company specializing in discovery and early-stage development through Phase 2 clinical trials before licensing to larger pharmaceutical and biotech firms for continued evaluation and marketing.