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.
Bioxytran (OTCQB: BIXT) ha completato con successo lo studio di ottimizzazione del dosaggio per il suo farmaco antivirale ProLectin-M in uno studio randomizzato, in doppio cieco e controllato con placebo. Lo studio ha valutato diverse dosi per 5 giorni con l'obiettivo principale di raggiungere una carica virale non rilevabile entro il giorno 7. Gli endpoint secondari includevano la valutazione della clearance virale precoce e il miglioramento dei sintomi secondo la Scala di Progressione Clinica dell'OMS. Studi precedenti avevano mostrato risultati promettenti con un tasso di risposta del 100% entro il giorno 7 e un tasso di risposta dell'88% entro il giorno 3. I dati supporteranno le sottomissioni sia alla FDA che alla CDSCO, oltre a guidare studi futuri per varie indicazioni virali tra cui COVID-19, Influenza, RSV ed EBV. L'azienda prevede di completare l'analisi dei dati e presentare i risultati per ulteriori studi fondamentali.
Bioxytran (OTCQB: BIXT) ha completado con éxito el estudio de optimización de dosis para su medicamento antiviral ProLectin-M en un ensayo aleatorizado, doble ciego y controlado con placebo. El estudio evaluó múltiples dosis durante 5 días con un objetivo principal de alcanzar carga viral indetectable para el día 7. Los objetivos secundarios incluyeron la evaluación temprana de la eliminación viral y la mejora de síntomas utilizando la Escala de Progresión Clínica de la OMS. Ensayos previos mostraron resultados prometedores con una tasa de respuesta del 100% para el día 7 y una tasa de respuesta del 88% para el día 3. Los datos respaldarán las presentaciones tanto a la FDA como a la CDSCO, además de informar futuros ensayos para diversas indicaciones virales, incluyendo COVID-19, Influenza, RSV y EBV. La compañía planea completar el análisis de datos y presentar hallazgos para ensayos adicionales clave.
Bioxytran(OTCQB: BIXT)는 항바이러스제 ProLectin-M의 용량 최적화 연구를 무작위 이중 맹검 위약 대조 시험에서 성공적으로 완료했습니다. 이 연구는 5일간 여러 용량을 평가했으며, 주요 목표는 7일째에 검출 불가능한 바이러스 부하를 달성하는 것이었습니다. 부차적 목표로는 조기 바이러스 제거 평가와 WHO 임상 진행 척도를 이용한 증상 개선이 포함되었습니다. 이전 시험에서는 7일째 100% 반응률과 3일째 88% 반응률이라는 유망한 결과가 나타났습니다. 이 데이터는 FDA와 CDSCO 제출을 지원하며, COVID-19, 인플루엔자, RSV, EBV 등 다양한 바이러스 적응증에 대한 향후 시험에도 참고될 예정입니다. 회사는 데이터 분석을 완료하고 추가 중추 시험을 위한 결과를 제출할 계획입니다.
Bioxytran (OTCQB : BIXT) a mené à bien l'étude d'optimisation de la dose pour son médicament antiviral ProLectin-M dans un essai randomisé en double aveugle contrôlé par placebo. L'étude a évalué plusieurs doses sur 5 jours avec pour critère principal d'obtenir une charge virale indétectable au jour 7. Les critères secondaires comprenaient l'évaluation précoce de l'élimination virale et l'amélioration des symptômes selon l'échelle de progression clinique de l'OMS. Des essais précédents avaient montré des résultats prometteurs avec un taux de réponse de 100 % au jour 7 et un taux de réponse de 88 % au jour 3. Ces données soutiendront les soumissions auprès de la FDA et de la CDSCO, tout en guidant les futurs essais pour diverses indications virales telles que COVID-19, grippe, RSV et EBV. La société prévoit de finaliser l'analyse des données et de soumettre les résultats pour d'autres essais pivots.
Bioxytran (OTCQB: BIXT) hat die Dosierungsoptimierungsstudie für sein antivirales Medikament ProLectin-M erfolgreich in einer randomisierten, doppelblinden, placebokontrollierten Studie abgeschlossen. Die Studie bewertete mehrere Dosierungen über 5 Tage mit dem primären Endpunkt, bis Tag 7 eine nicht nachweisbare Viruslast zu erreichen. Sekundäre Endpunkte umfassten die frühe virale Clearance und die Symptombesserung anhand der WHO-Klinischen Progressionsskala. Frühere Studien zeigten vielversprechende Ergebnisse mit einer 100%igen Ansprechrate bis Tag 7 und einer 88%igen Ansprechrate bis Tag 3. Die Daten werden die Einreichungen bei FDA und CDSCO unterstützen und zukünftige Studien für verschiedene virale Indikationen wie COVID-19, Influenza, RSV und EBV informieren. Das Unternehmen plant, die Datenanalyse abzuschließen und Ergebnisse für weitere entscheidende Studien einzureichen.
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:
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
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.
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