Bioxytran Profile
Bioxytran, Inc. (Bioxytran) operates as a clinical stage pharmaceutical company.
The company focuses on the development, manufacture and commercialization of therapeutic drugs designed to address hypoxia in humans, which is a lack of oxygen to tissues.
The company's lead drug candidate, code named BXT-25, is an oxygen-carrying small molecule consisting of bovine hemoglobin stabilized with a co-polymer with an intended application that includes the treatment of hypoxic conditions in the brain resulting from stroke. The company's approach is novel when applied to hypoxic conditions in humans. The company's drug development efforts are guided by specialists who work on co-polymer chemistry and other disciplines. The company intends to supplement its efforts with input from a scientific and medical advisory board whose members are leading physicians.
The company's subsidiary, Pharmalectin Inc. ('Pharmalectin' or the 'Subsidiary'), of which the company has 85% ownership, is focused on the development, manufacturing and commercialization of therapeutic drugs designed to address viral diseases in humans. Pharmalectin has developed a novel method designed to reduce the viral load and modulate the immune system using a galectin inhibitor. The company's lead drug candidate, named ProLectin-Rx, is a complex polysaccharide that binds to, and blocks the activity of galectin-1, a type of galectin. Galectins are a member of a family of proteins in the body called lectins. These proteins interact with carbohydrate sugars located in, on the surface of, and in between cells. This interaction causes the cells to change behavior, including cell movement, multiplication, and other cellular functions. The interactions between lectins and their target carbohydrate sugars occur via a carbohydrate recognition domain, or CRD, within the lectin. Galectins are a subfamily of lectins that have a CRD that bind specifically to ß-galactoside proteins. Galectins have a broad range of functions, including regulation of cell survival and adhesion, promotion of cell-to-cell interactions, growth of blood vessels, regulation of the immune response and inflammation. During viral infections galectins are upregulated and downregulated based on the type of virus.
The company has a novel approach in treating viral infections in humans. The company's drug development efforts are guided by specialists on carbohydrate chemistry and other disciplines, and the company intends to supplement its efforts with input from a scientific and medical advisory board whose members are leading physicians.
The company plans to file a pre-investigational new drug application for ProLectin-Rx for the treatment of mild to moderate Covid-19 patients. However, the company cannot provide any assurance that the company will successfully initiate or complete those planned trials and be able to initiate any other clinical trials for ProLectin-Rx or any of the company's future drug candidates.
The company's subsidiary, Pharmalectin (BVI), Inc. ('Pharmalectin (BVI)') is the owner and custodian of the company's copyrights, trade marks and patents.
The company's subsidiary, Pharmalectin India Pvt Ltd. ('Pharmalectin India') is managing the company's local clinical research and trials, and holds the local commercialization rights.
The company's lead pharmaceutical drug candidate is code named BXT-25 and is planned to be an oxygen-carrying small molecule consisting of bovine hemoglobin stabilized with a co-polymer. This modified hemoglobin will be designed to be an injectable intravenous drug and the company plans to begin pre-clinical studies and apply to the Food and Drug Administration for approval to use BXT-25 to prevent necrosis, or cell death, by carrying oxygen to human tissue with blood flow to the brain. If the company successfully completes Phase I testing with the FDA the company plans to explore the use of additional drug candidates using chemical structures that are a sub-class of BXT-25 that share the same physical properties to treat wound healing due to hypoxia, cardiovascular ischemia, anemia, cancer conditions and trauma, subject to FDA approval.
BXT-25 is a novel unproven technology. Although the company has not conducted research applying the company's co-polymer technology and related chemistry to the treatment of hypoxic conditions, the company know from Dr. Platt's prior research that the company's technology enables the creation of molecules that are 5,000 times smaller than human red blood cells and the company's proprietary technology will enable these molecules to carry oxygen for delivery to tissue through the bloodstream. The company may be unsuccessful in developing these technologies into drugs, which the United States Food and Drug Administration (FDA) ultimately will approve.
Hemoglobin and Complex Co-Polymer Science
The company's technology involves the development of hemoglobin-based oxygen carriers. To produce BXT-25, the company will take red blood cells (RBCs) from bovine sources, isolate hemoglobin from the RBCs and, by applying the company's proprietary co-polymer chemistry, stabilize and modify the hemoglobin. The company's novel, complex co-polymer molecules can be produced at specific molecular weights and with other pharmaceutical properties for various hypoxic diseases; and in the production of BXT-25.
The BXT-25 co-polymer hemoglobin molecule will be designed to be 5,000 times smaller than an RBC, which will enable that small molecule to reach hypoxic tissue more effectively than RBCs. BXT-25 will be designed to be administered as an injectable IV drug that will circulate in the blood collecting oxygen from the lungs and releasing the oxygen molecules where tissue has developed ischemia, or lack of oxygen. BXT-25 will be designed to have oxygen affinity that mimics RBCs, minimize adverse effects, and be compatible with all blood types. BXT will be designed to have a shelf life of two years at room temperature.
With regard to compatibility with all blood types, the differences between a BXT-25 molecule and a red blood cell will not be limited to differences in size. Surfaces of red blood cells include different antigens which determine the blood type as A, B, AB or O. BXT-25 will be found to be compatible with all blood types because it is a single, modified hemoglobin molecule stabilized with a co-polymer, which, unlike a red blood cell, has neither antigens nor a Rh factor.
The company's products include a commercially available raw material, bovine hemoglobin, that has been purified, chemically modified and cross-linked for stability. It is sourced from controlled herds of the U.S. cattle raised for beef production. Those herds are subject to and meet the requirements of a herd management program that assures the origin, health, feed and quality of the cattle used as a raw material source. The company's suppliers will contract to maintain traceable records on animal origin, health, feed and care as part of the company's effort to assure the use of known, healthy animals in compliance with applicable laws and regulations.
Pharmalectin
The company intends to apply its knowledge of galectin science and drug development to create new therapies for the treatment of viruses.
Covid-19
The company is working on an end-to-end solution for Covid-19 mild to severe cases and treatment for organ damage caused by the virus or by commonly used treatment methods.
ProLectin-M, a chewable polysaccharide tablet for mild to moderate cases of Covid-19.
ProLectin-I, a polysaccharide IV treatment for more severe cases of Covid-19.
ProLectin-F, a polysaccharide IV treatment of lung-fibrosis as a result of the use of ventilators used for the treatment of Covid-19.
ProLectin-A, a polysaccharide and Hemoglobin IV treatment of ARDS as a result of Covid-19.
Using the company's issued patents and proprietary technology coupled with the scientific knowledge and expertise of Dr. David Platt, the company intends to develop and manufacture ProLectin-M (oral) for the treatment of mild cases and ProLectin-I (intravenous) for the treatment of more severe cases of Covid-19. These treatments may also be used for the treatment of other types of viral infections, such as influenza.
A significant problem related to the Covid-19 pandemic is that an increasing number of patients are developing life-threatening complications, such as ARDS, shock (i.e., a potentially fatal drop in blood pressure), kidney failure, acute cardiac injury and secondary bacterial infections. The underlying cause for these complications is often a cytokine storm that results in a massive, systemic inflammatory response, leading to the damage of vital organs such as the lungs, heart, and kidneys, and ultimately multiple organ failure and death in many cases. For this purpose, the company is developing ProLectin-A that aim to deliver oxygen to damaged organs and at the same time fight infection.
The fourth drug in this series, ProLectin-F, is being developed to treat patients developing lung fibrosis as a result of the use of ventilator in Covid-19 treatment. An increasing evidence from experimental and clinical studies suggests that mechanical ventilation, which is necessary for life support in patients with acute respiratory distress syndrome, can cause lung fibrosis, which may significantly contribute to morbidity and mortality. According to a review of medical records of 22,350 admissions showed that the cost of treating patients who were put on a ventilator was four times higher than for those treated without a ventilator and also that the death rate of pulmonary fibrosis patients who were put on a hospital ventilator was seven times higher than those treated without a ventilator, according to a review of thousands of medical records.
The FDC Act and other federal and state statutes and regulations govern the testing, manufacture, safety, effectiveness, labeling, storage, record keeping, approval, advertising and promotion of the company's products.
BXT-25
Bioxytran intends to develop and, through third party contracts, manufacture oxygen therapeutics. The company's oxygen therapeutics are a new class of pharmaceuticals that are administered intravenously to transport oxygen to the body's tissues.
Using the company's proprietary technology, the company will develop and manufacture BXT-25 and similar drugs for applications, including treatment of stroke conditions. Bioxytran, Inc. has an exclusive license for an FDA approved technology monitoring NADH (OxySense), the control marker in the body's conversion of Oxygen to Energy, or the energy generating chain. The technology provides a clinical end-point for measuring oxygen supply to the brain in real-time. OxySense, developed by MDX LifeSciences, Inc., provide the company with a rapid and validated development of safe new molecules that address unmet medical needs in disease indications resulting from hypoxia. MDX LifeSciences has licensed a patent (Tissue Metabolic Score for Patient Monitoring - US20210153816A1) to Bioxytran for clinical monitoring of oxygen delivery through oxygen carriers. MDX Lifesciences is an Affiliate of the company.
ProLectin-Rx
The Subsidiary is focusing on the development, manufacturing and commercialization of therapeutic drugs designed to address viral diseases in humans. The company has developed a novel method designed to reduce the viral load and modulate the immune system using a galectin inhibitor.
The Subsidiary's lead drug candidate, named ProLectin-Rx, is a complex galectin antagonist that binds to, and blocks the activity of galectin-1, a type of galectin. Galectins are a member of a family of proteins in the body called lectins. These proteins interact with carbohydrate sugars located in, on the surface of, and in between cells. This interaction causes the cells to change behavior, including cell movement, multiplication, and other cellular functions. The interactions between lectins and their target carbohydrate sugars occur via a carbohydrate recognition domain, or CRD, within the lectin. Galectins are a subfamily of lectins that have a CRD that bind specifically to ß-galactoside proteins. Galectins have a broad range of functions, including regulation of cell survival and adhesion, promotion of cell-to-cell interactions, growth of blood vessels, regulation of the immune response and inflammation. During viral infections galectins are upregulated and downregulated based on the type of virus.
To the company's knowledge, Pharmalectin, Inc. is the only company planning to develop a viable end-to-end solution for Covid-19. The company is also the only company using a Galectin Inhibitor to combat the virus, SARS-CoV-2.
Using the company's issued patents and proprietary technology, the company intends to develop and manufacture ProLectin-RX and similar drugs for applications, including the treatment of virological conditions. The company's patent position consists of 2 parts: a patent a method for treating SARS-CoV-2 by administering an effective amount of complex polysaccharides to a subject issued in 2022 by the International Bureau of the Patent Cooperation Treaty (PCT) expiring in February 2041 (Polysaccharides for IV Administration that Treat Sars-Cov-2 Infections - WO2022/099061) and assigned to the company outright by David Platt, as well as a provisional patent (Lectin-Binding Carbohydrates for Treating Viral Infections - US 63/320544).
Pharmalectin, Inc. has an exclusive license issued by NDPD Pharma (Polysaccharides for Use in Treating Sars-Cov-2 Infections - WO2022/099052) to Pharmalectin for use of treatment of SARS-CoV-2. NDPD Pharma is an Affiliate of the company.
Further, Pharmalectin has received an international trademark for ProLectin (WO0000001646681).
On December 2, 2022, India's Central Drugs Standard Control Organisation (CDSCO) issued an IND with permission to conduct: 'A Phase 1b/2a Randomized, Blinded, placebo-controlled Study in Participants with Mild to Moderate COVID-19 to Evaluate the Safety, Efficacy, and Pharmacokinetics of Orally Administered ProLectin-M'. The study will continue by the filing of an Emergency IND with the FDA in the first quarter of 2023, provided the company obtains adequate funding. The company is in the process of filing an IND with the FDA.
On January 27, 2023, an additional IND with the CDSCO was issued for an IV treatment of SARS-CoV-2 in moderate (Hospitalized patients) Covid-19 infections (ProLectin-I), Long Covid, and of treatment of lung-fibrosis as a result of use of ventilator in the treatment of Covid-19 (ProLectin-F), respectively.
FDA Approval Process
In the United States, pharmaceutical products, including biologics like BXT-25, are subject to extensive regulation by the FDA. The FDC Act and other federal and state statutes and regulations, govern, among other things, the research, development, testing, manufacture, storage, recordkeeping, approval, labeling, promotion and marketing, distribution, post-approval monitoring and reporting, sampling, and import and export of pharmaceutical products. Failure to comply with applicable U.S. requirements may subject a company to a variety of administrative or judicial sanctions, such as FDA refusal to approve pending new drug applications, or NDAs, warning letters, product recalls, product seizures, total or partial suspension of production or distribution, injunctions, fines, civil penalties, and criminal prosecution.
BXT-25
Bioxytran's lead pharmaceutical drug candidate, code-name BXT-25, is an oxygen-carrying small molecule consisting of bovine hemoglobin stabilized with a co-polymer. This modified hemoglobin will be designed to be an injectable intravenous drug and the company plans to begin pre-clinical studies and apply to the Food and Drug Administration for approval to use BXT-25 to prevent necrosis, or cell death, by carrying oxygen to human tissue when blood flow to the brain.
The company plans to introduce BXT-25 in clinical trials for hypoxic medical conditions as stroke.
For the production of BXT-25, the company intends to utilize third party manufacturing facilities that are fully compliant with Good Manufacturing Practices (GMP) only, as required by the regulatory authorities in Europe or the United States, in order to produce a sufficient quantity of BXT-25 for animal toxicity and pre-clinical trials for animals. The company has not conducted any clinical trials on animals or humans to confirm the efficacy of, or filed any applications with the FDA with respect to, BXT-25. The company has developed a proof-of-concept production line and successfully manufactured the initial batch for use in pre-clinical trials in the first quarter of 2023, provided the company obtains adequate funding.
This product is being developed and as an early intervention in an out-of-hospital setting for the treatment of patients with ischemia of the brain resulting from a stroke or the blockage of the blood vessels to the brain. The company plans to initially conduct pre-clinical trials and to seek approval of BXT-25 for the treatment of adults at early stages of stroke.
ProLectin-Rx
If given early enough in the disease ProLectin-Rx will block viral entry and act as an antiviral by eliminating the virus from the blood stream after a couple of treatments. At a later stage in the disease pathology, ProLectin-Rx could restore adaptive immune function to help eradicate the virus from the body. In severe Covid-19 patients the drug could reduce the trafficking of macrophages responsible for the cytokine storm and restore immune homeostasis.
For the production of ProLectin-Rx, the company intends to utilize third party manufacturing facilities that are fully compliant with Good Manufacturing Practices (GMP) only, as required by the regulatory authorities in Europe or the United States, in order to produce a sufficient quantity of ProLectin-Rx for the company's upcoming human trials with the CDSCO in India. Prior to this the company has conducted clinical trials on animals and humans to confirm the non-toxicity and efficacy. The company also expects to file an IND application with the FDA in the first quarter of 2023, provided the company obtains adequate funding.
The oral product is being developed as a treatment for mild to moderate Covid-19 patients, while the intravenous drugs are developed for in moderate (Hospitalized patients) Covid-19 infections (ProLectin-I), Long Covid, and of treatment of lung-fibrosis (ProLectin-F).
European Directorate for the Quality of Medicines Certification (EDQM)
Certification from the European Directorate for the Quality of Medicines (EDQM) is required for all new and approved human and veterinary medicinal products that are manufactured from materials taken from cattle and marketed in the European Union. As part of the certification process, the company will be required to provide technical information on the manufacturing process, the origin of the raw material and type of tissue used, the cattle traceability, beginning at their country of birth, and auditing, and a risk analysis from an independent expert.
The company intends to establish and implement clinical development programs that add value to the company's business in the shortest period of time possible and to seek strategic partners when a program becomes advanced and requires additional resources. The company intends to continue focusing its expertise and resources to develop novel formulations, and to leverage development partnerships to apply the company's complex co-polymer chemistry designs in other medical indications. The company may seek to enter into licensing, co-marketing, or co-development agreements across different geographic regions, in order to avail ourselves of the marketing expertise of one or more seasoned marketing and/or pharmaceutical companies. The company plans to further develop new and proprietary drug candidates by using novel development pathways specific to each drug candidate.
A core part of the company's strategy relies upon creating safe and efficacious drug formulations that can be administered as standalone therapies or in combination with existing medications. The company utilizes a novel approach that is expected to create drug formulations that can be combined with existing therapies and potentially deliver valuable products in areas of high unmet medical needs. The company will assemble a scientific advisory board consisting of scientists with both academic and corporate research and development experience that will provide leadership and counsel in the scientific, technological and regulatory aspects of the company's projects. In addition, the company will assemble a medical advisory board consisting of leading physicians and key opinion leaders who have participated in relevant clinical studies and who will guide the company through ongoing clinical trial programs. The company's scientific and medical advisory boards consist of some of leading scientists, medical doctors and professionals in the co-polymer and ischemic brain injury field.
Research and Development (R&D)
During the twelve months ended December 31, 2022, the company recorded $977,768 in R&D expenses.
History
Bioxytran, Inc. was founded in 2008. The company was incorporated in 2008 as a Nevada corporation.
