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The viral inhibitor is a polysaccharide designed to block galectins
BOSTON, MASSACHUSETTS, March 24, 2020 (GLOBE NEWSWIRE) -- BIOXYTRAN, INC. (OTCQB:BIXT), a developmental stage biotechnology company developing a pipeline of anti-necrosis drugs designed to treat hypoxia by delivering a small molecule carrying oxygen to the brain of stroke victims announced today that it signed an exclusive worldwide licensing agreement with Dr. David Platt for the clinical development and further commercialization, of a galectin inhibitor that could potentially treat COVID-19. A presentation of the technology will soon be available.
Under the terms of the agreement, Bioxytran will pay a $5,000 down payment on the licensing fee to Dr. Platt by April 20, 2020. Future milestone payments of up to $4.0 million are due after; the first sample of GMP material, enrollment of the first patient in a Phase 1 trial, and an NDA approval in the United States. Royalties will range from 15 – 25% based on the amount of royalties received.
There is strong evidence that supports the possible use of a galectin inhibitor in COVID-19. According to the Centers for Disease Control and Prevention, the elderly population who have underlying medical conditions, such as diabetes, hypertension, organ fibrosis, or cancer are at a higher risk of getting very sick from this illness. What these people have in common is high lectin type galectin expression. High galectin blood serum concentrations are all associated with these underlying medical conditions which is why clinicians are having such a hard time treating COVID-19 using traditional therapies. Galectins have a tendency to degrade the immune system of people with underlying disease, which leaves them vulnerable against a cytokine storm.
Bioxytran’s new viral inhibitor is expected to restore the adaptive immune system to normal function, which should modulate any existing cytokine storm. In addition, there is preclinical evidence that a galectin inhibitor can bind to the protein spikes of the coronavirus. The company’s medical advisory board has theorized that binding to the virus could stop cell entry and assist in elimination of the virus which would then be attached to the drug and processed out by the liver.
Galectins are also at the center of a number of inflammatory cycles and thereby crucial in the pathogenesis of many chronic diseases such as organ fibrosis and psoriasis. Targeting these inflammatory pathways with an inhibitor could have the potential to quiet the immunological response which ultimately leads to a healing or a reduction in the side effects in many of these potential disease indications. Targeting galectins may have far reaching implications in many diseases thereby having platform technology potential.
“I have been researching galectins and complex carbohydrate modifications for over 35 years, and recent events necessitate an adjustment to our strategy,” said Dr. David Platt, CEO of Bioxytran Inc. “Galectins are part of COVID-19’s recognition system that facilitates viral entry. A few preclinical studies of the coronavirus genus have demonstrated a common galectin fold on the spike protein that is universal to the coronavirus genus. Galectin inhibitors are designed to interfere with this recognition process and prevent viral entry. Galectins are also modulators of the immune response and can be upregulated or downregulated to generate a pro-inflammatory or anti-inflammatory response. Our galectin inhibitor may be able to block viral entry and reduce the T-cell anergy. Our rationale for a viral entry inhibitor is based on extensive scientific evidence. We believe that our drug candidate can eliminate COVID-19. It is an important distinction to make that the viral inhibitor is not an antibody. Although it will be used as an antiretroviral, it should be recognized as an entry or fusion inhibitor that prevents the virus from entering the host cell.”
“The research that links COVID-19 to galectins is very attractive and an eye-opener to novel approaches to fight these deadly viruses,” said Juan Carlos Lopez-Talavera, MD, Ph.D., Consulting Medical Director for Bioxytran Inc. “During the SARS and MERS outbreaks much research was conducted on the composition of the virus with the hope of understanding how the virus works. Some of these studies openly concluded that galectins may represent a therapeutic target and should be investigated further. These outbreaks eventually subsided, and along with them, the motivation to conduct further research and development.”
“Bioxytran is simply connecting the dots by testing its theories with existing galectin inhibitors. The study titled Receptor Recognition Mechanism of Coronaviruses: a Decade of Structural Studies seems to implicate galectins in the pathogenesis of coronaviruses. Hence, galectin may represent an optimal target to treat COVID-19. Reduction of the viral load is a good treatment option, but may do nothing to address the cytokine storm which eventually results in Acute Respiratory Distress Syndrome (ARDS). Our galectin inhibitor can potentially reduce viral entry, help clearing the virus from the blood, and restore homeostasis to the immune system.”
Lectins are carbohydrate-binding proteins that are highly specific for sugar groups of other molecules. Lectins have a role in recognition on the cellular and molecular level and play numerous roles in biological recognition phenomena involving cells, carbohydrates, and proteins. Lectins also mediate attachment and binding of bacteria and viruses to their intended targets.
Galectins are a class of lectins that bind specifically to β-galactoside sugars. There have been 15 galectins discovered, which are numbered in a consecutive manner. Only galectin-1, -2, -3, -4, -7, -8, -9, -10 and -12 have been identified in humans. Galectin-5 and -6 are found in rodents, whereas galectin-11, -14 and -15 are uniquely found in sheep and goats.
COVID-19 is not the only virus that stole a host lectin and integrated it into their spike. A survey of viral lectins with known tertiary structures revealed that galectin-like domains are present in a variety of viral spikes, including influenza. These viral lectins display diverse sugar-binding modes.
About Galectin Inhibitors
Our investigative drug candidate is a polysaccharide designed to block galectins. Another galectin blocker has been through phase 2 clinical trials in cancer and was well tolerated in 140 patients that were dosed in a total of 9 clinical trials. In phase 2 study, it produced a disease stabilization rate of 75% in Chronic Lymphocytic Leukemia (CLL) blood cancer, but was never fully commercialized because the last licensee did not have the proper manufacturing expertise. Trials have also demonstrated that a galectin blocker can reverse T-Cell suppression. The safety profile is good, because there are no hematological toxicities and only a few severe adverse events related to rash consistent with immune modulation.
About Bioxytran, Inc.
Bioxytran Inc. is a developmental stage biotechnology company. The company is working towards a first-in-class oxygen treatment platform for victims of brain stroke trauma. The first product to proceed to testing is BXT-25, which will be evaluated as a resuscitative agent to treat strokes, especially during the all-critical first hour following a stroke. The product will also be evaluated for its efficacy in treating other brain trauma issues. BXT-25 is based on a new molecule designed to reverse hypoxia in the brain. Hypoxic brain injuries such as ischemic strokes, could be treated with BXT-25 via an intravenous injection that quickly allows the drug molecule to travel to the lungs and bind with the oxygen molecules. From the lungs the molecule mimics a red blood cell traveling to the brain. Since the molecule is 5,000 times smaller than red blood cells it can penetrate the clot and deliver the oxygen to the critical areas in the brain blocked by the clot. The MDX Viewer will be used in evaluation of the safety and efficacy of the BXT-25. To learn more, visit our website:
This press release includes forward-looking statements as defined under federal law, including those related to the performance of technology described in this press release. These forward looking statements are generally identified by the words “believe,” “expect,” “anticipate,” “estimate,” “intend,” “plan,” and similar expressions, although not all forward-looking statements contain these identifying words. Such statements are subject to significant risks, assumptions and uncertainties. Known material factors that could cause Bioxytran’s actual results to differ materially from the results contemplated by such forward-looking statements are described in the forward looking statements and risk factors in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2018 and those risk factors set forth from time-to-time in other filings with the Securities and Exchange Commission. Bioxytran undertakes no obligation to correct or update any forward-looking statement, whether as a result of new information, future events, or otherwise, except to the extent required under federal securities laws.
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