BOSTON, MASSACHUSETTS, May 12, 2025 (GLOBE NEWSWIRE) -- BIOXYTRAN, INC. (OTCQB: BIXT) (the "Company"), a clinical stage biotechnology company developing novel antiviral therapies, today announced the successful completion of the dose optimization of its antiviral drug ProLectin-M in a randomized double-blind placebo-controlled trial. Preliminary results are expected, with full data submission to the FDA under Bioxytran's active Investigational New Drug (IND) clinical trials for ProLectin-M.
Key Trial Details:
- Evaluated multiple ProLectin-M doses vs. placebo over 5 days
- Primary Endpoint: Undetectable viral load by Day 7
- Secondary Endpoints:
- Early viral clearance (Days 3 & 5)
- Symptom improvement (WHO Clinical Progression Scale)
- Safety/tolerability profile
Strategic Implications:
- Data will inform additional trials design for potential COVID-19, Influenza, RSV, EBV viral indications
- Supports FDA and Central Drugs Standard Control Organization (CDSCO) submissions per agency request
- Builds on prior trials showing:
- 100% responder rate (negative PCR) by Day 7
- 88% responder rate by Day 3
"This trial brings us closer to realizing ProLectin-M's potential as a first-line antiviral," said Dr. Leslie Ajayi, Bioxytran's Chief Medical Officer. "The consistency of our results, including 100% viral clearance in prior studies, gives us strong confidence as we prepare for additional clinical trials."
Next Steps:
- Complete data analysis
- Submit to FDA/CDSCO for additional pivotal trials
"Dose optimization is a critical milestone for our broad-spectrum antiviral platform," said David Platt, CEO of Bioxytran. "With this data, we can strategically advance ProLectin-M."
About ProLectin-M:
A complex carbohydrate therapeutic targeting viral entry mechanism, with potential applications in:
- upper respiratory viral infections
- Pandemic preparedness
About Bioxytran, Inc.
Bioxytran develops breakthrough therapeutics across three platforms:
1. Virology (ProLectin-M)
2. Oncology (metastasis inhibition)
3. Oxygen Transport (stroke/neurodegeneration)
The company's pipeline includes BXT-25, a potential stroke therapy that may reduce treatment delays by >90%. For more information, visit www.bioxytraninc.com
Investor Relations
Michael Sheikh
509-991-0245
mike.sheikh@bioxytraninc.com
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, 2023, 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.
