• First Medicinal chemistry of an antiviral drug made of sugars

BOSTON, MASSACHUSETTS, Feb. 21, 2024 (GLOBE NEWSWIRE) -- BIOXYTRAN, INC. (OTCQB: BIXT), (the “Company”), a clinical stage biotechnology company developing oral and intravenous drugs to treat viral diseases, announced that the first patients have been treated with ProLectin-M in its dose optimization trial. ProLectin-M is intended to become a first line treatment for standard risk COVID-19 patients, but based on the broad-spectrum in vitro discovery could easily expand to upper respiratory tract infections. Following this dose optimization trial, Bioxytran intends to use the trial data to inform the design of the Phase 3 registrational trial in India, while also adhering to the FDA’s request for additional data.

The multi-center clinical trial in India will be a randomized double-blind placebo-controlled trial and is set to enroll 40 patients. ProLectin-M has previously established efficacy in two, previously conducted, peer-reviewed clinical trials with a 100% responders rate in both trials and p-values of .05 and .001. In the past decade only one other antiviral has, to our knowledge, achieved a similar preliminary efficacy profile. The Company has already established the non-toxic profile of its galectin antagonists. Official additional studies are anticipated and planned in the United States.

“After we complete the dose optimization trial, the next regulatory milestone is a registrational trial,” said Dr. Leslie Ajayi, Bioxytran’s medical director. “We are on the cusp of completing a clinical trial of standard risk patient that contracted COVID-19. Completing our registrational trial will position our oral galectin antagonist as the first line therapy for the single largest respiratory viral disease indication in the world. Should we achieve approval in COVID-19, we will embark on an expansion plan that will include influenza and Respiratory Syncytial Virus (RSV). We have reason to believe that our galectin antagonist is a broad spectrum antiviral capable of neutralizing a number of viruses capable of upper respiratory tract infections. We are advancing the field of Glycovirology and working toward bringing to market the potential first broad spectrum antiviral capable of neutralizing a number of viruses without changing the formulation and theoretically resistant to viral mutations.”

“The discovery of a new binding region on the spike proteins of viruses has far reaching implications” said Kevin Mayo, Professor at the University of Minnesota, and also a member of Bioxytran’s scientific advisory board. “We used Nuclear Magnetic Resonance imaging to engineer / optimize a carbohydrate structure ideally suited to neutralize the spike protein of the SARS-CoV-2 virus. Before this discovery, neutralizing antibodies were only able to target the tip of the spike proteins of viruses which rapidly mutate, but after this discovery we found out that carbohydrates are able to neutralize viruses by binding to the galectin fold. The galectin fold represents a conserved structure on the spike protein virtually incapable of mutation, therefore it opens up a whole new field of research in Glycovirology. We believe a large number of viruses contain this galectin binding region on their spike proteins offering a widely druggable target that could be easily tested in a lab setting. With this discovery, we could use Nuclear Magnetic Resonance as a screening mechanism for viruses. In our COVID-19 case study we proved that the carbohydrate structures tested bound with high pico molar affinity, rarely seen with existing drugs, neutralize the viruses and that this data correlated with in vitro and the clinical trial results. We are at the dawn of a new age in virology that changes the current treatment paradigm of antivirals and vaccines to one of carbohydrate neutralization structures capable of efficiently neutralizing the virus to prevent cellular entry.”

About ProLectin-M

ProLectin-M is an oral galectin antagonist that prevents the entry of the SARS-CoV-2 virus into human cells. In recent clinical trials the drug achieved a 100% responders rate of negative PCR tests by day 7. In 3 days, the drug achieved an 88% responders rate of negative PCR tests. The treated population experienced no viral rebounds during the 14-day observation period. The company is preparing for a phase 3 clinical trial in order to seek regulatory approval.

About Bioxytran, Inc.

Bioxytran, Inc. is a clinical stage biotechnology company pioneering a library of novel carbohydrate structures using artificial intelligence software that interprets the Nuclear Magnetic Resonance spectroscopy fourier transformation mathematical process. The drug targets the galectin fold is a classical rational drug design. The leading drug candidates vetted by in vitro testing, are capable of neutralizing viruses. The peer-reviewed discovery of the galectin fold located on the spike proteins of viruses such as COVID-19, RSV, and H1N1 demonstrate there exists a conserved region on the spike in which Bioxytran’s molecules achieve virus neutralization. The extent of the carbohydrate structure’s ability to neutralize untested viruses is unknown just like the initial discovery of antibiotics last century and its ability to treat a broad spectrum of bacterial infections. Applications of this platform technology extend to the treatment of significant unmet medical needs in virology, degenerative disease, and hypoxia. The leading drug candidate, Prolectin-M, is a new class of antiviral drug designed to antagonize galectins implicated in inflammatory, fibrotic, and malignant diseases. Bioxytran’s other development programs are for pulmonary fibrosis and stroke treatment. More information can be found at www.bioxytraninc.com

Investor Relations
Michael Sheikh
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Forward-Looking Statements

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, 2021 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.