Journal Article correlates different neurological pathologies with Brain Metabolic Score and examines a neurological case study.

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"BOSTON, MASSACHUSETTS, February 28, 2020 (GLOBE NEWSWIRE) -- BIOXYTRAN, INC., a developmental stage biotechnology company with 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 the American Journal of Biomedical Science & Research released a peer-reviewed article that evaluated clinical situations in which the brain was resting or active using the Brain Metabolic Score's real-time multiparametric approach to data interpretation. (Mayevsky A. Real-Time Optical Monitoring of Brain Mitochondrial Function and Brain Metabolic Score (BMS) in Neuropathology. Am. J. Biomed. Sci.& Res. 7: 141- 172 (2020).)"

Animal studies were used to develop a mathematical model that essentially measures Brain Oxygen Balance. The article, entitled "Assessment of Brain Metabolic Score (MBS) In Vivo Based on Mitochondrial Activity in Neuropathology" was published by Prof. Avraham Mayevsky.

The article discusses the methodology used to prove that increased neuronal activity is correlated to the oxidation of NADH and that it can be measured using the Brain Metabolic Score. Additionally, this article serves as the rationale for using the Brain Metabolic Score as an endpoint in stroke and other neurodegenerative diseases where brain activity is compromised.

Other findings included in the animal experiments was that the monitoring of a very small sampling of the brain was representative of a volumetric sample of the brain that is able to detect global ischemia, anoxia, hypoxia, and hemorrhage. The device also demonstrated a minimally invasive way to measure cerebral ischemia which is essentially the supply of oxygen and carbon dioxide. Instead of disturbing and probing the brain tissue the probe was merely placed on the surface of the tissue.

The breakthrough came in what is described as "brain physiological mapping" that can use a minimally invasive technique to measure clinical conditions. These include Traumatic Brain Injury (TBI), brain ischemia, hemorrhage, hypothermia, sepsis, normobaric and hyperbaric oxygenation, and aging. In cases of brain activation, the device is capable of measuring different pathologies of cortical spreading depression, epileptic activity, and cerebral hypoxia.

A case study was presented whereby a patient with a head injury was taken to the ICU and connected to the Multiprobe Assembly (MPA) device. The patient responded to spontaneous changes to stimuli which matched all parameters, similar to the animal studies. The patient was monitored continuously for 7 hours and during that time was able detect a large increase in cerebral blood flow and the beneficial effect on brain oxygenation after treatment for high intracranial pressure 4.5 hours after being monitored to establish the patient's baseline.

Animal brains were tested in hyperbaric chambers that assessed the devices ability to detect increases or decreases in brain oxygenation. Tests also determined that the restoration of oxygen restored brain function. These tests were a proxy for using the Brain Metabolic Score as an endpoint to measure disease progression.

Neurodegenerative diseases are characterized by hypoxic tissue in the brain. There is clinical evidence that Hyperbaric Oxygen Therapy (HBOT) can reverse Alzheimer's Disease (AD). This disease indication represents a large unmet medical need. Researchers from Louisiana State University Health Sciences Center have the first PET scan-documented case of improvement in brain metabolism in AD in a patient that had hyperbaric oxygen chamber treatment.1 After 40 hyperbaric oxygen treatments over 66 days, the patient showed that they were able to halt the disease and temporarily reverse disease progression. These results are promising for the development of BXT-25, which in theory could provide a more extensive oxygen therapy for patients in a more convenient manner in the form of an intravenous shot.

"Determining biomarkers for neurodegenerative diseases has always been a challenge," said Dr. David Platt, CEO of Bioxytran Inc. "Subjective tests like the National Institute of Health Stroke Score (NIHSS) are used because no biomarkers exist to measure strokes. The Brain Metabolic Score has the potential to evolve into a biomarker that could be used to measure neurodegenerative diseases including Alzheimer's Disease. Advances in Alzheimer's has been stymied for years because the existing endpoints require thousands of patients to measure efficacy, which bloats the drug development costs and prolongs the studies. Powerful journal articles like this one, written by Myevsky, can sway the minds of key opinion leaders. When you take the work of Dr. Mayevsky and the work of the LSU Alzheimer study it really gives us a basis to pursue a clinical pathway in a field full of failures."

Platt continued "The linkage between hyperbaric oxygen treatment and BXT-25 is very strong. One can be substituted for the other. BXT-25 is an oxygen transport drug that was designed to be superior to hyperbaric oxygen treatment in many ways and not have all the constraints that currently exist for that treatment option. Both hyperbaric oxygen and BXT-25 are capable of treating the disease state of hypoxia in neurodegenerative diseases. Treating hypoxia in neurodegenerative diseases like Alzheimer's and stroke is a valid target that deserves further clinical investigation."

"I hope that my research paves the way for widespread use of the Brain Metabolic Score in clinical trials and eventually becomes an endpoint for various investigational drugs," said Avraham Mayevsky. "I also believe that patients in an ICU or a neurosurgical operation should be monitored for the Brain Metabolic Score. Surgeons in the operating room have to constantly filter data to determine the best course of treatment. If surgeons utilize the Brain Metabolic score they can quickly differentiate between localized and systemic issues during a surgical procedure allowing them to choose the optimal treatment pathway. There are many uses of the Brain Metabolic Score beyond surgery. As mentioned in my previous journal articles the Brain Metabolic Score could be easily adapted for use in testing different investigational drugs because the real-time monitoring would detect an increase in tissue oxygenation which is a consequence of the drug working to treat the desired indication."

"Key opinion leaders are warming up to the idea that hypoxia is a disease state that is treatable," said Juan Carlos Lopez-Talavera, Consulting Medical Director for Bioxtran Inc. "The latest Nobel Prize in health and medicine reinforced that many diseases have an element of hypoxia and appears to be more prevalent in neurodegenerative diseases. The Brain Metabolic Score is a true revolutionary concept in understanding brain functionality. It's important to see how one indicator can encapsulate so much functionality in a biomarker. BXT-25 is also an ideal molecule that is designed to deliver oxygen to starved organs including the brain. This is why Acute Respiratory Distress Syndrome (ARDS) is a good indication for BXT-25. The definition of ARDS is a lack of oxygenation in the blood that eventually leads to organ failure and death. ARDS is common after traumatic brain injury, sepsis, gastric aspiration, reperfusion injury, drug overdoses, cardiac surgery, pneumonia, inhalational injury, and respiratory infectious diseases including COVID-19."

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: http://www.Bioxytraninc.com.

References:
Hyperbaric oxygen therapy for Alzheimer's disease (January 24, 2019) Retrieved from https://www.sciencedaily.com/releases/2019/01/190124124742.htm

Contact:
Bioxytran
David.platt@bioxytraninc.com