December 2022: Beech Tree Labs (BTL) concludes COVID-19 FDA-authorized clinical trial
This small trial evaluated the effect of BTL-tml on duration and severity of COVID-19 in outpatients with underlying conditions. The study also assessed the safety of BTL-tml as well as its efficacy. The trial has completed, safety proven, with an insufficient number of subjects to attain statistical significance. A larger trial is being considered.
January 2022: Herpes trial results are published
This new publication reports the safety and efficacy of BTL-tml for the treatment of recurring herpesvirus infections.
Mamber SW, Hatch T, Miller CS, et al. Low-dose Oral Thimerosal for the Treatment of Oral Herpes: Clinical Trial Results and Improved Outcome After Post-hoc Analysis. Journal of Evidence-based Integrative Medicine. 2022 Jan-Dec;27:2515690X221078004.
DOI: 10.1177/2515690×221078004. PMID: 35142535; PMCID: PMC8841908.
June 2021: BTL welcomes a new board member
Doug Hulse is joining the board of Beech Tree Labs. Mr Hulse comes to the board with years of experience in the pharma industry. He has served in various management positions as a consultant, fund raiser and on multiple boards. He is currently the CEO of BCI Life Science. His extended bio can be found here.
March, 1 2021: Patient enrollment completed for the COVID-19 trial
Beech Tree labs announces that enrollment for its COVID-19 trial has been completed. Data analysis will follow.
October 2020: New site open for BTL’s COVID-19 clinical trial
Beech Tree labs announces that patients in the New Orleans area can now be enrolled in the study testing the effect of TML on symptoms of COVID-19. The study targets patients 50 years and older, who tested positive for COVID-19 and are not hospitalized. The study is entirely remote as participants receive treatment, instructions and device to report on symptoms at home. TML is administerd for ten days sublingually.
To learn more, visit BTL’s COVID-19 page.
September 18, 2020: Beech Tree Labs selects Curavit Clinical Research for fully virtual COVID-19 clinical trial
PARK CITY, Utah, Sept. 18, 2020 /PRNewswire/ — Beech Tree Labs has chosen Curavit Clinical Research for a fully decentralized clinical trial to investigate a promising Covid-19 therapy. The FDA-authorized phase 2 clinical study will evaluate the effect of Beech Tree’s BTL-TML therapy on mean duration and severity of disease in 40 outpatients aged 60 years or older with underlying conditions. The study also assesses the safety of BTL-TML over 10 days of treatment and an additional four days of follow-up.
The trial is unique in that it is a fully decentralized clinical trial, made possible by applying virtual trial design protocols, digital telehealth technologies, electronic patient reported outcomes (ePRO), and full web and contact center patient support to eliminate the need for in-person office visits.
Thomas Hatch, Director of Business Development at Beech Tree said: “We chose Curavit because of their exclusive focus on designing and executing virtual trials. We needed a company with Curavit’s expertise in this important new discipline of clinical research in order to make this trial possible.” Joel Morse, CEO of Curavit added: “This is a unique opportunity to apply modern trial design and telehealth technologies to allow patients to participate in this study without the potential risk of traveling to physical sites and to participate from the safety and comfort of their own homes.”
Curavit is a new type of clinical research company that designs and executes decentralized – also called “virtual” – clinical trials. Curavit brings together the world’s leading researchers, enrolls previously untapped and underserved patient populations, applies machine learning algorithms to health and social engagement information, and leverages leading telehealth, patient data platform, and medical device technologies.
ABOUT BEECHTREE LABS
Located in Providence, RI, Beech Tree Labs, Inc. (BTL) focuses on the discovery and early development of therapeutic agents that address a spectrum of unmet medical needs. The company has an extensive portfolio of patented formulations for products intended to treat such disorders as urinary incontinence, allergies, benign prostatic hypertrophy, anxiety, chronic obstructive pulmonary disease and herpesvirus infections. BTL has conducted over 15 FDA- authorized phase 2 trials and has out-licensed both technology and products.
LEARN MORE ABOUT THIS STUDY
The current FDA-approved Phase II pilot study is taking place in Draper, Utah at Intermountain Clinical Research. Additional sites will open in the future. To learn more about this study:
August 5, 2020: Clinical trial underway in Salt Lake City, UT
Beech Tree Labs, Inc. was featured in a news topic on KSL TV. Watch the video here and read the article below.
FDA-approved study for potential COVID-19 treatment underway in Draper
A New York-based drug company is starting a U.S. Food and Drug Administration-approved clinical study on a new drug to determine whether or not it could treat COVID-19.
“If this works, this has the potential to be absolutely groundbreaking,” said Dr. Duane Harris, an allergy and asthma specialist and clinical investigator in Draper. Harris has tested many drugs over the years, but nothing like this drug, which has such worldwide potential. “The thought is that it works by changing cell signaling in the affected cells, maybe interrupting the viral replication in the cell,” he said.
Thomas Hatch, director of business development for Beech Tree Labs, the company behind the drug, said the drug was made 20 years ago as a potential treatment for herpes, but it never went to market. “This one happened to be sitting on the back burner and we had tested it extensively for the herpes virus and we thought, ‘let’s try it for COVID-19,’” Hatch told KSL.
The company started a media campaign in Utah to find 40 patients to participate in phase two of the FDA-approved study. Researchers are looking for people over 60 who tested positive for COVID-19 and have current health issues. “We will collect information from these patients all from the comfort of their own home. We don’t have any patients coming into a hospital or doctor’s office,” said Hatch. “We are pretty confident our drug can do some good things, but we have to prove it.”
The drug is not meant to cure those who are already hospitalized or in critical condition. It’s meant to catch the disease early so a person does not end up in the hospital. “We want people that we can prevent from getting sick instead of trying to fix the people that are already seriously ill,” said Harris.
The drugmakers said they were very optimistic. If they can get 40 people, then the trial itself will take only about 14 days. Then they can move to phase three, where they bring in hundreds of patients. If that proves successful, they were hoping the drug could be on the market before the end of the year.
Visit our COVID-19 page to learn more about a BTL-TML.
July 6, 2020: BTL-TML approved for clinical investigations
Beech Tree Labs, Inc. announced today that its investigational new drug application (IND) for BTL-TML as a potential treatment for COVID-19 has been approved by the US Food and Drug Administration (FDA). BTL-TML has already been demonstrated to be safe and effective as a treatment for Herpesvirus infections and has shown promise in treating influenza and Ebola.
The pilot trial will be conducted in Salt Lake City, Utah among people with early-stage COVID-19 infection. The trial will start within a month and results will be available in the fall.
Visit our COVID-19 page to learn more about a BTL-TML.
May 13,2020: New publication: Can unconventional Immunomodulatory Agents Help Alleviate COVID-19 Symptoms and Severity?
The Beech tree Labs team publishes “Can unconventional Immunomodulatory Agents Help Alleviate COVID-19 Symptoms and Severity?” in the peer-reviewed journal mSphere, published by the Amercian Society for Microbiology.
This article explores the use of low-dose oral interferon alpha, microdose DNA, low-dose thimerosal, and phytocannabinoids to modulate COVID-19 related symptoms.
Can Unconventional Immunomodulatory Agents Help Alleviate COVID-19 Symptoms and Severity?
May 2020: BTL’s older formulations to be sold over the counter by Molecular Signals, LLC
The board of directors of Beech Tree Labs, Inc. has agreed to spin off several older formulations to be sold over the counter by a wholly-owned subsidiary, Molecular Signals, LLC.
Molecular Signals’ first products are expected to include a formulation for respiratory health, another for allergies, one for urinary incontinence and, interestingly, a formulation to assist in preventing or relieving poison ivy sensitivity.
Each of these products will be offered as a mint that is infused with the energetic signature of the respective molecules.
Sales are anticipated to commence during the summer.
April 16, 2020: John McMichael is in the news!
Watch this short video from News10, a local news channel in the area of Albany, NY.
President & CEO of Beech Tree Labs seeks FDA approval for TML COVID-19 treatment
April 2020: Beech Tree Labs is developing a potential antiviral therapy to fight COVID-19 pandemic.
Beech Tree Labs is preparing to evaluate its antiviral products, BTL-TML, in an FDA authorized phase 2 trial with 40 symptomatic outpatients that have tested positive for COVID-19. Quarantined patients will be treated for ten days and final data will be collected on day 14.
BTL-TML is administered via sublingual drops. Previous anecdotal experience has shown BTL-TNL to be effective in treating influenza, cytomegalo, Epstein-Barr, human papilloma and Ebola virus infections. Two FDA phase 2 trials showed BTL-TML to be safe and effective in treating recurrent oral herpesvirus infections when patients were exposed to ultra-violet light or a dental procedure.
Patients in these controlled trials had a history of developing cold sores under these conditions, but lesions were aborted in those treated with BTL-TML.
Results of this phase 2 COVID-19 trial are expected by mid-summer 2020.
November 27, 2018: Traumatic Brain Injury Patent Allowed
Resolys Bio, Inc., a majority-owned spinout of Beech Tree Labs, Inc., received notice of allowance from the U.S. Patent and Trademark Office for the use of streptolysin O (oSLO) to treat traumatic brain injury (TBI). OSLO is the lead product candidate of Resolys Bio. It functions as a biological signal molecule that helps restore intra- and inter-cellular communication, downregulate inflammation, enhance circulation, breakdown scar tissue, and inhibit gliosis. The Company is preparing to file an IND application in 2019.
Please visit www.resolysbio.com for more information on Resolys Bio, TBI, and oSLO.
July 16, 2018: New BTL Formulation for Hearing Loss
Beech Tree Labs has initiated the evaluation of a new formulation for the treatment of hearing loss. Although compromised hearing can occur from a variety of causes such as exposure to loud noises, fever infection, hysteria, and concussion to normal aging, it is this last condition, called presbycusis, that is the present focus. Early results are encouraging, but more evaluation is necessary before proceeding to a formal clinical trial.
December 11, 2017: Seeking License for BTL-tml
Beech Tree Labs has completed two FDA-authorized clinical trials to evaluate BTL-TML, its anti-viral product, for the treatment of recurrent oral herpes simplex infections. The combined results of these trials were positive, and efforts to license BTL-tml to a larger company are underway.
March, 2016: BTL spins off its formulations for Traumatic Brain Injury and Chronic Tissue Disorders
BTL created a wholly-owned subsidiary called Resolys Bio, Inc. Resolys has been assigned all rights, current and future, for formulations developed by BTL addressing traumatic brain injury (TBI) and chronic tissue disorders such as Joint Hypermobility Syndromes (JHS), Lupus, Rheumatoid Arthritis, and Fibromyalgia. Resolys Bio is a privately held clinical-stage biotechnology company focusing on therapeutic agents for chronic disorders for which there is little or no competition.
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.
Beech Tree’s founder and CEO, Dr. John McMichael says, “The results of our Phase 2 evaluations of BTL-TML for the treatment of recurrent oral herpes infections are encouraging and provide the impetus to identify a partner to move forward with pivotal Phase 3 trials and initiate further controlled trials to test BTL-TML’s efficacy for treating additional members of the herpes family.”
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.”
COPD is a progressive disease caused by chronic inflammation and destruction of the airways and lung parenchyma. It is most often associated with tobacco smoking although aging, asthma, and exposure to environmental pollutants also contribute. There are currently no drugs on the market to reverse this disorder.
“The essential function of gas exchange is highly dependent on the lung’s structurally fragile architecture,” says John McMichael, president and CEO of Beech Tree Labs, Inc. “This fragility is easily compromised by minor changes in composition of lung tissue, especially by scarring subsequent to inflammation. There is an urgent need in the market for drugs that can not only alter the underlying inflammation associated with COPD and relax the airway smooth muscles, but also a product that can slow and even reverse scarring and loss of lung function.
“Our drug candidate appears to reduce scarred lung tissue, potentially restoring lung function while simultaneously stimulating the cilia lining the airway to beat stronger and faster to enhance clearance of mucus and particulate contaminates. The combination of clearance and improved structural conditions allows for improved respiratory efficiency.”
Beech Tree Labs, Inc. is a privately held biopharmaceutical company with an extensive patent portfolio that includes other potential therapeutics targeting a broad spectrum of chronic disorders. The Company’s focus is on discovery and early-stage development through Phase 2 clinical trials and then out-licensing to larger pharmaceutical and biotech firms for continued evaluation and marketing.
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.