PROVIDENCE, R.I.--()--Beech Tree Labs, Inc. announced today that it has initiated a Phase 1/2a clinical evaluation of its novel therapeutic agent, UISH001, for treating urinary incontinence (UI). This FDA-approved study is a 60 patient, placebo-controlled trial.
As referenced by the National Association for Continence, UI affects 200 million people worldwide. Twenty five million adult Americans experience transient or chronic UI with 75 to 80 percent of those sufferers women, 9 to 13 million of whom have bothersome, severe, symptoms. In addition, one-third of men and women ages 30 to 70 have experienced loss of bladder control at some point in their adult lives and may be still living with the symptoms. The cost of managing UI in the U.S. alone exceeds $20 billion.
Treatment approaches have ranged from drugs to plugs to hypnosis. In one small IRB-approved blinded study, the Company’s product candidate for the treatment of UI has demonstrated efficacy in treating urge, stress, and mixed incontinence.
Beech Tree's founder and CEO, Dr. John McMichael said, "The incidence of urinary incontinence is increasing as a consequence, in part, of our aging society. It represents an unmet medical need since most of the products now available are accompanied by adverse effects for a significant number of patients. This phase 2a trial is being conducted to determine if UISH001 can meet that need."
Beech Tree Labs is a privately held biopharmaceutical company, a leader in novel molecular signaling technology with an extensive patent portfolio that includes other potential therapeutics targeting a broad spectrum of chronic disorders. The Company specializes in discovery and early-stage development through Phase 2 clinical trials and out-licenses to larger pharmaceutical and biotech firms for continued evaluation and marketing. In addition to this trial, Beech Tree is currently conducting a FDA Phase 1/2 clinical trial for recurrent oral herpes.