Clinical trial to compare sublingual low does thimerosal in adults that have symptoms of SARS-CoV-2 Infection against placebo to show a difference in physical characteristics and viral levels.

Start Date30 Jul 2020

Sponsor / Collaborator

Beech Tree Labs, Inc.

[+1]

NCT01902303

/ CompletedPhase 2

Evaluation of Cold Sore Treatments on UV Induced Cold Sores

The purpose of this study is to determine if a new drug treatment is effective to block the development of a cold sore lesion following Ultra Violet (UV) exposure.

Start Date01 Jul 2013

Sponsor / Collaborator

Beech Tree Labs, Inc.

[+1]

NCT01308424

/ CompletedPhase 1/2

A Randomized, Double-blind, Parallel, Placebo-controlled Study for the Assessment of the Safety and Efficacy of BTL-TML-HSV for the Treatment of Recurrent Symptomatic Oral Herpes Virus Infection

The purpose of this study is to determine if a new treatment is effective for the treatment of recurrent symptomatic oral herpes virus infections.

Start Date01 Jan 2011

Sponsor / Collaborator

Beech Tree Labs, Inc.

100 Clinical Results associated with BTL-TML

100 Translational Medicine associated with BTL-TML

100 Patents (Medical) associated with BTL-TML

1,360

Literatures (Medical) associated with BTL-TML

01 Mar 2025·Dermatitis®

Patch Test Results with the Latin American Baseline Series in a Colombian Population. 2016–2021

Article

Author: Díez-Zuluaga, Libia Susana ; Crespo-Vergara, Nardey María ; Rodas-Areiza, Juan Sebastián ; Santamaría-Salazar, Luis Carlos ; Calle-Álvarez, Ana María

Background: Contact dermatitis (CD) is one of the most prevalent skin diseases. It is commonly divided into irritant contact dermatitis (ICD) and allergic contact dermatitis (ACD). Patch testing is a procedure used to support the diagnosis of ACD. This test should be interpreted along with the clinical history and morphology of the skin lesions to determine clinical relevance. Objective: To describe the sensitization patterns of patients undergoing patch testing with the Latin American baseline series. Methods: A single-center retrospective study was performed. For the study, patients older than 18 years with a clinical diagnosis of contact dermatitis, who underwent patch testing using the Latin American baseline series were considered. These tests took place at the Alma Mater Hospital of Antioquia between January 1, 2016, and December 31, 2021. Results: A total of 648 patients were included. Patch tests were positive in 63% of cases, with a mean age of 51.5 years. Around 36.6% had atopy-related diseases. The main occupation was housework (30.7%). The hands were the most affected area in the body (31%). The main allergens were nickel sulfate (34%), sodium tetrachloropalladate (24.2%), and thimerosal (8.0%). Fifteen allergens had a percentage below 1%. Hydrocortisone and budesonide did not yield positive results. Conclusion: Nickel sulfate was the most frequent allergen, and women were the most affected. The information gathered could be useful for adjusting the allergens that should be included in the regional baseline series, taking into account the frequency found.

01 Jan 2025·Vaccine

Comparative study on the inactivation and immunogenicity of Mycoplasma hyopneumoniae and Mycoplasma hyorhinis vaccines prepared using different inactivants

Letter

Author: Wei, Yanna ; Liu, Beibei ; Xiong, Qiyan ; Wang, Jia ; Yu, Yanfei ; Feng, Zhixin ; Yuan, Ting ; Wang, Li ; Khoza, Thandeka Ntokozo ; Shao, Guoqing

The present study aimed to investigate the optimal inactivants and inactivation conditions for preparing inactivated vaccines of Mycoplasma hyopneumoniae and Mycoplasma hyorhinis. Mycoplasma inactivation was performed using formaldehyde, thimerosal, β-propiolactone (BPL), and binary ethylenimine (BEI) and compared. The results showed that M. hyopneumoniae was completely inactivated when incubated with 0.01 % formaldehyde for 24 h or 0.02 % formaldehyde for 12 h at 37 °C, with 0.0008 % thimerosal for 12 h at 37 °C, with 0.02 % BPL for 24 h or 0.1 % BPL for 12 h at 4 °C, or with 0.004 % BEI for 24 h or 0.5 % BEI for 12 h at 37 °C. M. hyorhinis was completely inactivated when incubated with 0.01 % formaldehyde for 24 h or 0.02 % formaldehyde for 12 h at 37 °C, with 0.004 % thimerosal for 24 h or 0.02 % thimerosal for 12 h at 37 °C, with 0.1 % BPL for 12 h at 4 °C, or with 0.004 % BEI for 24 h or 0.5 % BEI for 12 h at 37 °C. Next, the immunogenicity of the mycoplasmas after inactivation was evaluated by immunizing BALB/c mice. Immunization of mice with a high dose (10⁶ color-changing units [CCU] per dose) of M. hyopneumoniae and M. hyorhinis vaccines inactivated with all inactivants led to high levels of serum IgG antibodies. M. hyopneumoniae vaccines inactivated with formaldehyde induced significantly higher titers of antibodies than vaccines inactivated with other inactivants, whereas M. hyorhinis vaccines inactivated with BEI induced significantly higher titers of antibodies than vaccines inactivated with thimerosal. However, in mice immunized with a low dose of mycoplasmas (10⁴ CCU per dose), only M. hyopneumoniae vaccines inactivated with formaldehyde and BEI and M. hyorhinis vaccines inactivated with formaldehyde, BPL, and BEI led to significant levels of serum IgG antibodies. Among these groups, the antibody levels in the formaldehyde-inactivated vaccine group were higher than those in the other inactivant groups. This study provides a reliable basis for inactivation during large-scale production of Mycoplasma hyopneumoniae and Mycoplasma hyorhinis inactivated vaccines.

01 Jan 2025·Comparative Biochemistry and Physiology Part C: Toxicology & Pharmacology

Adverse effects of thimerosal on the early life stages of zebrafish

Article

Author: Dong, Kejun ; Zong, Chenrui ; Su, Youqin ; Li, Lixia ; Li, Qingchen ; Li, LeYan

Thimerosal (THI) is an organic mercury compound that is widely used in drugs, vaccines and antibacterial products. Its extensive production and use have resulted in significant environmental contamination, posing a considerable threat to aquatic life. However, the knowledge of the toxicity of THI to aquatic organisms is still insufficient. In this study, we conducted a 5-day THI exposure experiment using zebrafish, from 0 to 5 days post fertilization (dpf). The possible adverse effects of THI on the early-life stages of zebrafish were explored by investigating variations in their physiological parameters, behavioral traits, and neurotransmitter levels. The results showed THI exhibited significant developmental toxicity to aquatic organisms. Exposure to THI significantly induced serious malformation (at 50 μg/L), accelerated hatching, and elevated heart rate (at 5 and 50 μg/L). The behavioral traits of zebrafish larvae had an increased first and then decreased relationship with increasing concentration of THI, which induced hyperactivity at 0.5 μg/L but opposite at 50 μg/L. Furthermore, exposure to 50 μg/L THI significantly raised levels of 5-HT, 5-HIAA, DA, DOPAC and ACH in zebrafish larvae. In addition, several significant correlations between behavioral traits and the neurotransmitter contents were detected, which seemed to reveal an important mechanism of the neurobehavioral toxicity of THI to fish.

News (Medical) associated with BTL-TML

17 Apr 2025

·www.biospace.com

Kennedy’s Hunt for a Connection Between Vaccines and Autism Is a Sham

iStock, BeritK The Health and Human Services Secretary said that he will find and eliminate the cause of autism by September, an idea that suggests how little he knows about the condition. Last week, Health and Human Services Secretary Robert F. Kennedy Jr. announced that he is marshaling the force of his agency to discover the link between vaccines and autism. He suggested that this new research project could be completed by September, a lightning quick turn-around for any research project. He offered no other details on what exactly he and HHS will do. Of course he does not need to wait even as long as September. The link between autism and vaccines has been investigated time , and time , and time , and time again. Whether it’s the vaccines themselves or thimerosal, a preservative that used to be used in vaccines but no longer is, there is no link between vaccines and autism. The rising rate of autism diagnoses—ostensibly part of the reason for Kennedy’s concern—is universally agreed to be the result of increased awareness of the condition. Autism can be a difficult thing to manage, and if the pharmaceutical industry could find a way to monetize it—with a pill, a shot, anything—there is no doubt that it would. The truth is that there are no drug treatments specific for autism. All of the most common drugs given to people with the condition are behavioral drugs—like the classic antipsychotic Haldol, a drug that works quite a bit like a tranquilizer, or common anti-depressants like Zoloft or Prozac. Atypical antipsychotics like risperidone and aripiprazole are also used. There are no drugs that have ever been developed and approved solely for autism, and the industry is nowhere close to achieving that. Even if an autistic person—or any person anywhere, for that matter—never paid taxes or wrote a poem, that doesn’t make them fodder for Kennedy’s wild political hallucinations. The most commonly cited source of autism behaviors is genetic, usually pointing at genes involved in the synapse and with dopamine, which can be related to autism’s classic traits of social deficits and repetitive behavior. But these are not “symptoms”—everyone with autism is different. Kennedy might as well be on the hunt for why neighbors are sometimes jerks or people on the bus can be unusual. Kennedy’s thoughts about what could “cause” autism are also extremely retrograde. It’s barely worth repeating that vaccines are largely safe and that Andrew Wakefield’s paper connecting the measles-mumps-rubella vaccine to autism and setting off anti-vaccine hysteria was completely fraudulent . Recent studies have found that autism cases are more or less evenly distributed around the world, meaning there is likely no such thing as an “environmental cause” of autism: not toxins, not pollution and definitely not vaccines. The comments that Kennedy makes about autism are troubling, to put it in the most polite way possible. It is clear to me that at the very least he has crude and outdated ideas about how science works, and at worst he sees autism as a heinous plague to be eradicated, rather than just a different, uncommon set of behaviors that tend to butt up against common social norms, which isn’t much of a pathology. Look at how Kennedy describes people with autism in an April 15 press conference: “These are kids who will never pay taxes,” Kennedy declared. “They’ll never hold a job. They’ll never play baseball. They’ll never write a poem. They’ll never go out on a date.” None of that is true! People with autism live full and rich lives—they marry, have children, hold jobs, play sports and write poetry. Nothing about autism prevents any of those things, and it’s insulting to those people and their family members that the head of America’s health agencies sees autistic people this way. And even if an autistic person—or any person anywhere, for that matter—never paid taxes or wrote a poem, that doesn’t make them fodder for Kennedy’s wild political hallucinations. Like anyone else, they deserve dignity. It is frightening that the most powerful politician at the head of the country’s health agency is so given to conspiracy theories that have been debunked over and over and is so willing to use a vulnerable population of people as a political prop. The country needs a health official who actually cares about the people his policies affect—I don’t think Kennedy is that man. But there are ways to help people on the spectrum and their families, and they are much more prosaic than Kennedy seems to think. They are things like access to care, assessments, and various types of therapy like Applied Behavior Analysis under Medicaid. We could also fund more teacher’s aids to support students with autism in the school system. Instead, Kennedy and President Trump are drastically shrinking the National Institutes of Health—one of the nation’s centers for autism research, while attempting to totally destroy the Department of Education. Take a step back and it’s clear: The administration does not want to help these families at all. They are just more grist for the conspiracy mill.

Vaccine

09 Dec 2024

·endpts.com

Trump elevates disproven link between vaccines and autism, saying ‘something is going on’

In his first major interview since securing another term in the White House, President-elect Donald Trump reiterated concerns with the disproven link between childhood vaccines and autism, a nod to the movement that’s foundational to some of his health policy team. When asked by Kristen Welker of NBC News whether he wanted to see childhood vaccines eliminated, Trump said, “if they’re dangerous for the children.” The interview, which aired Sunday , signaled Trump’s willingness to debate the health benefits of childhood vaccination. Trump brought up the rising rates of autism as a potential rationale for investigating childhood vaccines, saying, “If you go back 25 years ago, you had very little autism.” “I mean, something is going on. I don’t know if it’s vaccines,” he said. “Maybe it’s chlorine in the water, right? You know, people are looking at a lot of different things.” (Trump may have been referring to fluoride.) Rising rates of autism diagnosis have been a foundational theory for anti-vaccine activists, particularly Robert F. Kennedy Jr., who’s become a global crusader on the front and is Trump’s pick to lead the Department of Health and Human Services. Trump also picked Dave Weldon as his CDC director, a former congressman and practicing physician who has been sympathetic to people concerned with claimed links to autism. Repeated studies have disproved theories that a mercury-based preservative found in vaccines, thimerosal, causes autism. Thimerosal is increasingly not in use anymore, due to reformulations and updates to vaccines, according to the FDA . Trump stopped short of widely casting doubt on all vaccines and said he was “not against vaccines.” He specifically touted the polio vaccine as the “greatest thing,” for example. “I think vaccines are — certain vaccines — are incredible. But maybe some aren’t. And if they aren’t, we have to find out,” he said. But the comments open the door to shifting US vaccine policy, which relies in part on vaccinating large percentages of people to create widespread immunity that stops the spread of infectious diseases. Experts have warned that decreasing rates of childhood vaccination could prompt the rise of diseases that have largely been eliminated, like measles. Trump also used the NBC interview to confirm reports that he met with top pharma executives at Mar-a-Lago last week, along with Mehmet Oz, Kennedy and others. Axios first reported that Trump dined with the CEOs of Eli Lilly, Pfizer and the lobbying group PhRMA on Wednesday evening. A spokesperson for Lilly declined to comment and Pfizer didn’t respond to a request for comment. A spokesperson for PhRMA confirmed CEO Stephen Ubl’s attendance, but declined to provide further details. Trump said that a focus of the meeting was drug middlemen, a reference to pharmacy benefit managers who have increasingly drawn bipartisan ire. Reforms for the PBM industry are being considered in Congress’ continuing resolution, a mechanism for funding the government. “Number one, we’re going to reduce prices because the middleman makes more money than the drug companies, in all fairness to the drug companies,” Trump said. Rep. James Comer (R-KY), who led an investigation into the companies, followed Trump by tweeting that it was “time for reform.” The dinner conversation also included vaccines and pesticides, Trump said. He added that Kennedy is “not going to upset any system” and he’s “not looking to reinvent the wheel totally.” “The drug companies are going to be working with RFK Jr. and, you know, he’s been an interesting guy to me,” he said of Kennedy.

Vaccine

29 Jan 2015

·www.biospace.com

Protein Sciences Corporation Release: Clinical Efficacy Study Of Flublok® Quadrivalent Compares Flublok To A Traditional Egg-Based Flu Vaccine

MERIDEN, Conn., Jan. 29, 2015 /PRNewswire/ -- Protein Sciences Corporation announced today that results from a double-blinded comparative efficacy study of Flublok Quadrivalent in adults over 50 are expected in June. The study is designed to demonstrate whether Flublok's higher antigen content and its modern production process that avoids the introduction of egg-based mutations into the vaccine's active ingredients will result in better efficacy than the recently announced flu vaccine efficacy of 14% in adults older than 50. PSC12 is a large trial in adults 50 years of age and older intended to demonstrate the protective efficacy of Flublok Quadrivalent in prevention of influenza disease. The trial enrolled 9,000 participants at sites across the U.S. The efficacy of Flublok Quadrivalent is being compared to that of a licensed conventional egg-based inactivated quadrivalent vaccine. Flublok Quadrivalent is a quadrivalent version of Flublok influenza vaccine that is designed to protect against two A subtypes and two B lineages of influenza. Trivalent Flublok that protects against two A subtypes and one B lineage of influenza is licensed by the FDA for all adults 18 and older and is available for general use. Flublok has gained popularity due to its purity, egg-free nature and high antigen content and is considered especially important in a flu season such as this that is severe due to the predominance and drift in the H3N2 virus. The recombinant technology used to make Flublok is able to perfectly match circulating flu strains and, therefore, may prove more effective than traditional vaccines. Clinical trials have suggested that the higher antigen content of Flublok provides significant protection against drifted influenza viruses. A separate Phase 3 clinical trial of Flublok Quadrivalent is being conducted in adults 18-49 years of age. PSC16 is intended to demonstrate that satisfactory immune responses are elicited for all four influenza proteins by Flublok Quadrivalent. The trial enrolled 1,350 adults across the U.S. and will compare Flublok Quadrivalent to a licensed conventional egg-based inactivated quadrivalent vaccine. Results are also expected in June. "There has been a shift in influenza vaccines to quadrivalent formulations," commented Manon Cox, President and CEO of Protein Sciences. "Our recombinant platform technology that we use to make Flublok and all other vaccines allows us to rapidly and predictably manufacture antigens that are perfectly matched to circulating influenza strains, whether it be the addition of a fourth antigen as in the case of Flublok Quadrivalent, or to update the annual formulation of Trivalent Flublok. PSC12 and PSC16 put us on track for receiving regulatory approval of Flublok Quadrivalent in the next year or two." Trivalent Flublok is available now. Healthcare professionals seeking the vaccine should contact FFF Enterprises at 800-843-7477 or online at . Consumers seeking Flublok should visit . About Protein Sciences Protein Sciences specializes in vaccine development and protein production. Our mission is our inspiration: to save lives and improve health through the creation of innovative vaccines and biopharmaceuticals. Flublok, the world's first recombinant protein-based vaccine for the prevention of seasonal influenza disease, was approved by FDA in January 2013. Flublok is the only flu vaccine made in a 100% egg-free system using modern cell culture technology, making it unnecessary to use an infectious influenza virus or antibiotics in manufacturing. Flublok is highly purified and does not contain any preservatives (e.g., thimerosal, a mercury derivative), egg proteins, gelatin or latex. In addition, Flublok contains three times more antigen than traditional flu vaccines (3x45mcg hemagglutinin protein versus 3x15mcg hemagglutinin protein)*. Flublok is a perfect copy of the virus coat and is not subject to the egg-adapted mutations associated with low vaccine effectiveness (see Skowronski et al. (2014) PLOS ONE 9(3), e92153). Healthcare professionals can order Flublok by contacting FFF Enterprises at 800-843-7477. Learn more at and . Flublok Safety Information Flublok is approved for people 18 and older to prevent influenza disease. The most common side effect from Flublok is pain at the site of injection. Headache, fatigue or muscle ache may occur. Tell the doctor if you have ever experienced Guillain-Barre syndrome (severe muscle weakness) or have had a severe allergic reaction to any component of Flublok vaccine. Vaccination with Flublok may not protect all individuals. Clinical effectiveness in adults 50 and older is based on the immune response elicited by Flublok and not on demonstration of decreased influenza disease. Please see the complete Package Insert available at or call 203-686-0800 for more information. *Flublok demonstrated a higher antibody response to the A strains during 2 clinical trials in adults 50 years old. The B strain antibody response was comparable to traditional trivalent vaccines. Logo - To view the original version on PR Newswire, visit: SOURCE Protein Sciences Corporation Help employers find you! Check out all the jobs and post your resume.

VaccineCollaborateAntibody

100 Deals associated with BTL-TML

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KEGG	Wiki	ATC	Drug Bank
-	BTL-TML	D08AK06	DB11590

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Influenza, Human	Phase 2	-	Beech Tree Labs, Inc.	-
COVID-19	Discovery	United States	Beech Tree Labs, Inc.	30 Jul 2020
Herpes Labialis	Discovery	United States	Beech Tree Labs, Inc.	01 Jul 2013
Stomatitis, Herpetic	Discovery	United States	Beech Tree Labs, Inc.	01 Jul 2013

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