Bioxytran Completes Dose Optimization of Antiviral, ProLectin-M

Rhea-AI Summary

Bioxytran (OTCQB: BIXT) has successfully completed the dose optimization study for its antiviral drug ProLectin-M in a randomized double-blind placebo-controlled trial. The study evaluated multiple doses over 5 days with a primary endpoint of achieving undetectable viral load by Day 7. Secondary endpoints included early viral clearance assessment and symptom improvement using WHO Clinical Progression Scale. Previous trials showed promising results with 100% responder rate by Day 7 and 88% responder rate by Day 3. The data will support submissions to both FDA and CDSCO, while informing future trials for various viral indications including COVID-19, Influenza, RSV, and EBV. The company plans to complete data analysis and submit findings for additional pivotal trials.

Positive

• Successful completion of dose optimization trial for ProLectin-M
• Previous trials showed 100% responder rate by Day 7
• Strong early efficacy with 88% responder rate by Day 3
• Potential broad-spectrum application across multiple viral indications

Negative

• Full trial results not yet available
• Still requires additional pivotal trials for approval
• Trading on OTCQB market rather than major exchange

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.

FAQ

What were the key results from Bioxytran's (BIXT) ProLectin-M dose optimization trial?

The trial evaluated multiple ProLectin-M doses vs. placebo over 5 days, with previous trials showing 100% responder rate by Day 7 and 88% responder rate by Day 3. Full results are pending analysis.

What viral indications is Bioxytran's (BIXT) ProLectin-M targeting?

ProLectin-M is being developed for multiple viral indications including COVID-19, Influenza, RSV, and EBV viral indications.

What are the next steps for Bioxytran's (BIXT) ProLectin-M development?

Bioxytran plans to complete data analysis and submit findings to FDA and CDSCO for additional pivotal trials.

What were the endpoints in Bioxytran's (BIXT) ProLectin-M trial?

The primary endpoint was undetectable viral load by Day 7, with secondary endpoints including early viral clearance on Days 3 & 5 and symptom improvement using WHO Clinical Progression Scale.