BOSTON, MASSACHUSETTS — February 21, 2024 (GLOBE NEWSWIRE) — Bioxytran, Inc. (OTCQB: BIXT), a clinical-stage biotechnology company developing oral and intravenous therapeutics for viral diseases, today announced that the first patients have been treated with ProLectin-M in the Company's dose optimization trial.
ProLectin-M is an oral galectin antagonist being developed as a potential first-line treatment for standard-risk patients with COVID-19. Based on the Company's broad-spectrum in vitro findings, Bioxytran believes the therapeutic approach could potentially be expanded to other upper respiratory tract infections.
Following completion of the dose optimization trial, Bioxytran intends to use the resulting data to inform the design of a Phase 3 registrational trial in India, while continuing to address the U.S. Food and Drug Administration's request for additional data.
The multicenter clinical trial in India is designed as a randomized, double-blind, placebo-controlled study and is expected to enroll 40 patients. According to the Company, ProLectin-M previously demonstrated efficacy in two peer-reviewed clinical trials, with a 100% responder rate reported in both studies and p-values of 0.05 and 0.001, respectively.
Bioxytran has also reported a non-toxic profile for its galectin antagonists and anticipates conducting additional studies 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 patients who contracted COVID-19. Completing our registrational trial will position our oral galectin antagonist as a 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 responsible for upper respiratory tract infections.
“We are advancing the field of Glycovirology and working toward bringing to market what could potentially be the first broad-spectrum antiviral capable of neutralizing a number of viruses without changing the formulation and theoretically remaining resistant to viral mutations.”
Kevin Mayo, Professor at the University of Minnesota and a member of Bioxytran's Scientific Advisory Board, highlighted the potential significance of identifying a new binding region on viral spike proteins.
“The discovery of a new binding region on the spike proteins of viruses has far-reaching implications,” said Professor Mayo. “We used Nuclear Magnetic Resonance imaging to engineer and 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. After this discovery, we found that carbohydrates are able to neutralize viruses by binding to the galectin fold.
“The galectin fold represents a conserved structure on the spike protein that is virtually incapable of mutation, opening 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 laboratory setting.
“With this discovery, we could use Nuclear Magnetic Resonance as a screening mechanism for viruses. In our COVID-19 case study, we demonstrated that the carbohydrate structures tested bound with high picomolar affinity, rarely seen with existing drugs, neutralized the viruses, and that this data correlated with the in vitro and 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.”
ProLectin-M is an oral galectin antagonist designed to prevent SARS-CoV-2 from entering human cells.
In recent clinical trials, the drug achieved a reported 100% responder rate for negative PCR tests by Day 7, while an 88% responder rate for negative PCR tests was reported by Day 3. According to the Company, the treated population experienced no viral rebound during the 14-day observation period.
Bioxytran is preparing for a Phase 3 clinical trial as part of its efforts to seek regulatory approval for ProLectin-M.
Bioxytran, Inc. is a clinical-stage biotechnology company pioneering a library of novel carbohydrate structures using artificial intelligence-enabled drug design. The Company's technology incorporates Nuclear Magnetic Resonance spectroscopy and Fourier transform-based mathematical analysis to identify and optimize carbohydrate structures against druggable targets such as the galectin fold.
The Company's leading drug candidates have undergone in vitro evaluation for antiviral activity. Peer-reviewed research into the galectin fold located on the spike proteins of viruses including COVID-19, RSV, and H1N1 has identified a conserved region of the viral spike that Bioxytran's molecules are designed to target for virus neutralization.
The broader platform is being investigated for potential applications addressing significant unmet medical needs in virology, degenerative diseases, and hypoxia. The Company's leading drug candidate, ProLectin-M, represents a new class of antiviral drug designed to antagonize galectins implicated in inflammatory, fibrotic, and malignant diseases.
Bioxytran's other development programs include therapeutic approaches for pulmonary fibrosis and stroke.
This press release contains forward-looking statements as defined under federal law, including statements regarding the potential performance and applications of the technology described in this press release. These forward-looking statements are generally identified by words such as “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 those contemplated by these statements are described in the forward-looking statements and risk factors included in the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2021, as well as in other filings made by the Company with the Securities and Exchange Commission from time to time.
Bioxytran undertakes no obligation to correct or update any forward-looking statement, whether as a result of new information, future events, or otherwise, except as required under applicable federal securities laws.
Bioxytran, Inc.
Website: www.bioxytraninc.com
Investor Contact:
Michael Sheikh
509-991-0245
mike.sheikh@bioxytraninc.com
