March 8, 2016: BTL-slo Shows Promise for Treating Traumatic Brain Injury
In collaborative research with investigators from Boston Children’s Hospital, Harvard Medical School, Beech Tree’s product candidate BTL-slo demonstrated efficacy in treating acute traumatic brain injury. In this study, mice treated with BTL-slo showed improvement in memory as compared to untreated animals and BTL-slo prevented the increase in microglial cells associated with trauma in the memory region of the brain. These results support anecdotal observations of BTL-slo treated patients who have improved after suffering severe accidents or repeated concussions.
November 12, 2015: BTL-hs Addresses Muscle Weakness
Bench lab, animal model, and formal clinical trial studies provide significant evidence that Beech Tree Labs’ novel product candidate, BTL-hs, addresses different forms of muscle weakness. For example, Beech Tree successfully completed a Phase 2a clinical evaluation of BTL-hs targeting urinary incontinence. 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. This patented, two-component formulation has demonstrated efficacy in treating urge, stress, and mixed urinary incontinence as well as fecal incontinence.
Complementing clinical trial outcomes were data from the Cleveland Clinic’s work using BTL-hs with their rat model for urinary incontinence. In this series of experiments, statistically significant results were obtained for multiple test parameters, especially in that portion of the work focusing on stress incontinence. This study was published in Neurology and Urodynamics.
In addition, the findings of Beech Tree’s MDX mice experiments, a recognized model for Duchenne muscular dystrophy (DMD), indicate that BTL-hs increased functional muscle performances of MDX mice as determined by weekly grip strength tests. These findings were consistent with in vitro studies where normal human BioArtificial muscles (BAMs) were used as a model for muscle active force and muscle injury tests using MyoForce Analysis System (MAFSTM).
This therapeutic approach does not alter the genomic anomaly associated with DMD, so the effect is not DMD specific. In fact, three other forms of MD have responded to BTL-hs. As a result, other disorders characterized by untoward muscle weakness might likewise be targets for BTL-hs therapy. Expanded animal experiments and human clinical trials are anticipated.
July 21, 2015: Beech Tree Labs Announces Positive Results for IND Phase 2 Oral Herpes Clinical Trials
Providence, RI, July 21, 2015 (GLOBE NEWSWIRE)—Beech Tree Labs, Inc. announced today that it has completed its second Phase 2 clinical trial in which its candidate product BTL-tml was evaluated for treating recurrent oral herpes infections. The primary endpoint of the randomized, placebo-controlled Phase 2b trial as well as the earlier Phase 2a trial was to prevent lesion formation. In contrast, other anti-herpes therapies focus on reducing the time it takes a lesion to heal as the chief measure of efficacy.
Participants in both trials were instructed to begin sublingual drop administration of BTL-tml upon first evidence of a herpes prodrome as characterized by tingling, itching, burning, or similar sensation. The goal was to abort later, more symptomatic lesion stages induced by either a dental procedure (Phase 2a) or exposure to ultra-violet light acting as a surrogate for excessive sun exposure (Phase 2b).
Combining relevant data from the Phase 2b and Phase 2a studies showed that more than 50 percent of all subjects experiencing a prodrome were able to avoid lesion development by timely administration of BTL-tml, resulting in clinical and statistically significant difference between BTL-tml treated patients and those receiving placebo. The adverse events profiles of the two groups were similar. [Full Release.]
February 17, 2015: Duchenne Muscular Dystrophy Studies Yield Promising Results
Duchenne muscular dystrophy (DMD) is considered to be an incurable, progressive muscular degenerative disorder. It is caused by a mutation of the X chromosome resulting in the absence of dystrophin protein and leading to premature death in affected individuals. The findings of BTL’s MDX mice experiments, a recognized model for DMD, suggest that the administration of a combination of two patented therapeutic agents significantly increased functional muscle performances of MDX mice as determined by weekly grip strength tests. These findings were consistent with in vitro studies where normal human BioArtificial muscles (BAMs) were used as a model for muscle active force and muscle injury tests using MyoForce Analysis System (MAFSTM).
While the MD-model mice responded favorably to BTL therapy, the treatment is not specific to that disease nor does it alter the genomic anomaly associated with muscular dystrophy. Consequently, other disorders characterized by untoward muscle weakness might likewise be targets for this therapeutic approach. Expanded animal experiments and human clinical trials are anticipated.
December 2, 2014: Beech Tree Labs Allowed Patent for COPD Therapy
Providence, RI, (GlobeNewswire)—Beech Tree Labs, Inc. announced today that it received notice of allowance from the U.S. Patent and Trademark Office (USPTO) for a patent covering the company’s novel product candidate to treat chronic obstructive pulmonary disease (COPD). The patent teaches the use of the combination of low-dose DNA and streptolysin O for this indication.
COPD is the fifth leading cause of death worldwide and is expected to rise to the third leading position in the near future. A report published in Lancet states that “in a large, multi-cultural, North American population…about one in four people older than 35 years are likely to be diagnosed with COPD during their lifetime.” [Read full release.]
September 8, 2014: BTL-tml a Versatile Anti-Viral Agent
In vivo and in vitro research conducted by Beech Tree Labs indicates that its anti-viral formulation, BTL-tml, is effective in inhibiting herpesvirus in dogs, cats, cattle, and humans, influenza types A and B, and members of the papilloma/polyoma family. Although differing in size, shape, and molecular structure, BTL-tml prevents replication of all three virus types. Work continues to determine both the mode(s) of action of BTL-tml and the total spectrum of viruses for which it could be efficacious. A Phase 2b clinical trial evaluating BTL-tml for treating recurrent oral herpes is nearing completion and the Company holds an open IND to evaluate this agent for the treatment of influenza.
August 21, 2014: Herpes Trial Nears Completion
A final site has been selected for the Phase 2b clinical trial to evaluate Beech Tree's anti-viral agent, BTL-tml, for recurrent oral herpes infections. The trial is completed with data analysis expected early 2015. Pre-clinical data suggest the efficacy of this product candidate in addressing all forms of herpesvirus infections in several host species. Reflecting the utility of Beech Tree's novel formulations, the Company also holds an open IND to evaluate BTL-tml for the treatment of influenza.
August 15, 2014: Expanding Patent Portfolio
Beech Tree Labs was recently issued US and European patents for the use of BTL-SLO to inhibit cancer metastasis. SLO is a single molecule which is a non-toxic form of a common bacterial toxin. Demonstrating the versatility of agents in Beech Tree's novel Resonant Molecular Signaling platform, an IND application to investigate the use of SLO for complications arising from total knee replacement is being prepared. Beech Tree now holds over 100 issued patents with a significant number pending worldwide.
March 24, 2014: The Resonant Molecular Signaling Discovery Engine
Beech Tree Labs is ushering in an entirely new approach to treating disease along with enhancing the medical science understanding of how the body works.
Over decades of research, Beech Tree Labs’ investigators developed the Resonant Molecular Signaling (RMS) platform, an innovative approach to treating disease. Sixteen successful FDA-authorized clinical trials for a variety of disease indications, a list of scientific publications, numerous animal-model studies, and a portfolio consisting of more than 150 issued patents attest to the efficacy of the agents comprising this platform. Only placebo-level adverse events were noted in each of the above mentioned trials, thereby indicating a highly desirable safety profile.
As measured by past, present, and planned clinical trials, Beech Tree now manages a powerful discovery engine that routinely targets new approaches to treating difficult diseases. For example, a recently completed trial centered on urinary incontinence, a trial in progress focuses on oral herpes, a trial in the planning stages concerns complications from total knee replacement, and another planned trial focuses on muscular dystrophy.
RMS formulations are characterized by the administration of precise physiological doses of a molecule or combination of molecules, depending on the disease. The underlying theory of RMS is that a healthy state is marked by normal signaling within and between cells while disease is caused by disruption of this norm. Accordingly, the mechanisms underlying these formulations are different than current pharmacological approaches to product discovery. The goal of RMS therapies is to interrupt pathophysiology by selective molecular intervention—thereby restoring normal regulatory function via cellular signaling rather than by the attack-and-destroy approach commonly used with pharmaceuticals, a process that often produces adverse effects.
January 3, 2014: Jeffrey Eckmann Joins Board of Directors
Beech Tree Labs is pleased to announce the appointment of Jeffrey Eckmann to the Board of Directors. Now retired, Jeff Eckmann served as Group President for Reynolds American, Inc., where he had responsibility for four of RAI’s five business units. More information on Mr. Eckmann and our Board of Directors may be found at Board of Directors.
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