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Beech Tree Labs Announces Successful Urinary Incontinence Clinical Trial
Release Date: November 6, 2012

Providence, RI--(BUSINESS WIRE)--Beech Tree Labs, Inc. announced today that it has completed a successful Phase 2a clinical evaluation of its novel therapeutic agent, UISH001, for treating urinary incontinence (UI). This FDA-authorized study was a multi-site, 67-patient, placebo-controlled trial.

Patients were treated for four weeks with sublingual drops of the test product or placebo. Results showed all test parameters to be in favor of the treatment population, with the most significant (p=0.039) reflecting a decrease in the use of pads for leakage. The test group showed placebo-level side effects.

Complementing the clinical trial outcomes were results from the Cleveland Clinic’s work using the same test formulation with their rat model for urinary incontinence. In this series of trials, statistically significant results were obtained for multiple test parameters, especially in that portion of the study focusing on stress incontinence.

Beech Tree’s founder and CEO, Dr. John McMichael said, “The combined results of this first clinical trial and the Cleveland Clinic outcomes are extremely encouraging. With this data in hand, we are confident that the next trial will provide even more robust results as we are better able to define target populations for a longer trial.”

UI affects 200 million people worldwide, with increasing incidence due to an aging population. There are currently no pharmaceutical drugs on the market to effectively treat stress incontinence, and all UI drugs have limited efficacy and may produce serious adverse effects. The Company’s product candidate for the treatment of UI has demonstrated efficacy in treating urge, stress, and mixed incontinence.

The Company is a leader in molecular signaling technology with an extensive patent portfolio that includes other potential therapeutics targeting a broad spectrum of chronic disorders. Beech Tree Labs is a privately held biopharmaceutical company specializing 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.


NCRA collaborating as BTLs preferred CRO on Regulatory Submissions and Upcoming Trials:

Beech Tree Labs' Urinary Incontinence Trial Begins: Release Date: April 13, 2011

Providence, RI--(BUSINESS WIRE)--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.

Beech Tree Labs' Oral Herpes Trial Begins: Release Date: September 14, 2010

Providence, RI--(BUSINESS WIRE)--Beech Tree Labs, Inc. announced today that it has initiated a Phase 1/2a clinical evaluation of its novel therapeutic agent for treating recurrent oral herpes infections. This FDA-approved study is a 210 patient, multi-site, placebo-controlled trial of its agent BTL-TML-HSV.

According to WHO and CDC statistics, over 80 percent of the population have oral herpes with about 20 percent of these expressing symptoms. In addition, one of four adults has genital herpes, with the incidence steadily increasing. Treatment options for herpes are limited.

Beech Tree's founder and CEO, Dr. John McMichael said, "While our initial clinical focus in on oral herpes, we have evidence that suggests our patented agent may address a broad range of herpes virus indications." He went on to say, "The active agent is also embodied in a product candidate that recently received FDA approval of an IND targeting influenza, reflecting a growing anti-viral platform." Patient enrollment for the influenza trial will begin at the onset of the upcoming flu season.

Beech Tree Labs is a privately held biopharmaceutical company, a leader in 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 furthering its partnership outreach, Beech Tree is attending BioPharm America 2010 being held this week in Boston.


FDA Approves Beech Tree Labs' Recurrent Oral Herpes Infections IND Application Another successful collaboration milestone for NCRA and BTL! News source: Business Wire. July 7, 2010

Providence, RI--(BUSINESS WIRE)--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 of 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 herpes virus 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.
Beech Tree Labs is a privately held biopharmaceutical company specializing in discovery and early-stage development through Phase 2 clinical trials, followed by licensing to larger pharmaceutical and biotech firms for late-stage evaluation and marketing. It is a leader in resonant molecular signaling technology and holds a number of patents on other potential therapeutics.


FDA Approves Beech Tree Labs' Influenza IND Application
Another successful collaboration milestone for NCRA and BTL!
News source: Business Wire.  January 29, 2010
Beech Tree Labs, Inc., announced today that the FDA has approved its IND for a 180 patient Phase 1/2a clinical evaluation of BTL-TML001, a novel therapeutic agent for treating acute influenza virus infections.
In the United States it is estimated that outbreaks of seasonal flu incur annual costs of more than $12 billion with a mortality rate of over 36,000 people. In the case of a pandemic, estimated annual costs would range from $71 to $167 billion for attack rates of 15-35 percent of the population.
Beech Tree Labs is a privately held biopharmaceutical company specializing in discovery and early-stage development. It is a leader in resonant molecular signaling technology and holds a number of patents on other potential therapeutics.