- Trial meets endpoints in safety and efficacy
- IND Letter from the CDSCO to optimize dosage
- Establishment of an Indian Subsidiary to commercialize ProLectin-M
BOSTON, MASSACHUSETTS, Dec. 28, 2022 (GLOBE NEWSWIRE) — BIOXYTRAN, INC. (OTCQB: BIXT) (the “Company”), a clinical stage biotechnology company developing oral and intravenous drugs to treat COVID-19 and other viral causing diseases announces that Crystal Research provided an update on BIXT.
Crystal research reported that the Company announced positive topline safety and efficacy results from its randomized, placebo-controlled Phase 2 clinical trial in 34 patients with mild-to-moderate COVID-19. During the 7 days of treatment, an orally administered Galectin Antagonist in the form of a chewable tablet was administered 8 times per day on an hourly basis. The trial met its endpoint with a 100% response rate by day 7 versus 6% in placebo, which was statistically significant (p-value=.001) and something that has only ever been accomplished by one other drug in the past decade. The Company’s analysis also revealed an 88% response rate by day 3, which was statistically significant (p-value=.001).
During the quarter the company also announced its receipt of an Investigational New Drug (IND) authorization letter from India’s Central Drugs Standard Control Organization (CDSCO) to optimize dosage in COVID-19 patients. The trial’s objective is to provide guidance for a 408 patient Phase III trial that will be finalized after analyzing the data from the optimization trial. The Company also announced that it had established an Indian subsidiary (Pharmalectin India Private Limited), with a purpose to launch commercial product sales of ProLectin-M should the company receive Central Drugs Standard Control Organization (CDSCO) approval. The Indian manufacturing plant is an FDA-approved facility that is capable of supporting the Indian market with a population of 1.4 billion people.
The update also covered the mechanism of action (MOA) detailed in the latest pre-print in greater depth.
Nuclear Magnetic Resonance testing was used to elucidate the Mechanism of Action of the specific Galectin Antagonist. Tests concluded that ProLectin-M (PL-M) binds relatively strongly to Galectin-3 with high micromolar affinity. While the galectin antagonist does indeed bind to the S1 Spike Protein, the study showed that it could bind in 2 different orientations. The Nuclear Magnetic Resonance (NMR) binding data was so precise that it measured 5 molecules of Galectin-3 were need to neutralize 1 spike protein. This finding demonstrated 5 binding sites for the Galectins. The final experiment revealed that Lactose which is a common sugar that we ingest competes with Galectin-3. These findings on the mechanism of action helped inform the decisions on dosing, duration, and ingestion.
The full text of the preprint is located at the following link.https://www.medrxiv.org/content/10.1101/2022.11.09.22282151v1
About Bioxytran, Inc.
Bioxytran, Inc. is a clinical stage biotechnology company developing novel therapies targeting 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
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.