Provectus Biopharmaceuticals Initiates Preclinical Study of Oral PV-10 in Bladder Cancer
Provectus Biopharmaceuticals (OTCQB: PVCT) has launched a preclinical study of its lead drug PV-10 for bladder cancer treatment. The study, conducted by TD2, will evaluate both oral and intravesical monotherapy applications, as well as combination therapy with an anti-PD-1 checkpoint inhibitor.
The research aims to generate translational data to guide future clinical development and support broader immuno-oncology applications. Results are expected in Q1 2026. The study's findings will potentially enable expansion of PV-10's investigational new drug application for both site-specific and systemic administration.
Provectus Biopharmaceuticals (OTCQB: PVCT) ha avviato uno studio preclinico del suo farmaco di punta PV-10 per il trattamento del cancro della vescica. Lo studio, condotto da TD2, valuterà sia l’uso come monoterapia orale sia intravescicale, oltre alla terapia combinata con un inibitore di checkpoint anti-PD-1. La ricerca mira a generare dati traslazionali per guidare lo sviluppo clinico futuro e supportare applicazioni più ampie di immuno-oncologia. I risultati sono attesi nel Q1 2026. I risultati dello studio potrebbero permettere l’espansione della domanda di nuovo studio per PV-10 sia per somministrazione mirata che sistemica.
Provectus Biopharmaceuticals (OTCQB: PVCT) ha iniciado un estudio preclínico de su fármaco principal PV-10 para el tratamiento del cáncer de vejiga. El estudio, realizado por TD2, evaluará tanto la monoterapia oral como intravesical, así como la terapia combinada con un inhibidor de punto de control anti-PD-1. La investigación busca generar datos translacionales para guiar el desarrollo clínico futuro y apoyar aplicaciones más amplias de la inmuno-oncología. Se esperan resultados en el primer trimestre de 2026. Los hallazgos podrían permitir la expansión de la solicitud de aprobación de PV-10 para administración local y sistémica.
프로벤트스 바이오제약(OTCQB: PVCT)은 방광암 치료를 위한 자사 주력 약물 PV-10의 전임상 연구를 시작했다. TD2가 수행하는 이 연구는 경구 단독요법과 방광 내 단독요법 모두를 평가하고 Anti-PD-1 체크포인트 억제제와의 병용요법도 살펴볼 것이다. 연구의 목표는 향후 임상 개발을 안내하고 면역항암학 응용을 확대하기 위한 번역적 데이터를 생성하는 것이다. 결과는 2026년 1분기에 기대된다. 연구 결과는 PV-10의 임상시험신약신청서를 표적적용 및 전신투여 모두에 대해 확장 가능하게 할 수 있다.
Provectus Biopharmaceuticals (OTCQB : PVCT) a lancé une étude préclinique de son médicament phare PV-10 pour le traitement du cancer de la vessie. L’étude, réalisée par TD2, évaluera à la fois les applications en monothérapie orale et intravésicale, ainsi que la thérapie associée à un inhibiteur de point de contrôle anti-PD-1. La recherche vise à générer des données translationnelles pour guider le développement clinique futur et soutenir des applications plus larges en immuno-oncologie. Les résultats sont attendus au premier trimestre 2026. Les conclusions de l’étude pourraient permettre l’expansion de la demande d’Investigational New Drug pour PV-10, tant par administration ciblée que systémique.
Provectus Biopharmaceuticals (OTCQB: PVCT) hat eine präklinische Studie zu seinem Spitzenmittel PV-10 zur Behandlung von Blasenkrebs eingeleitet. Die von TD2 durchgeführte Studie wird sowohl orale als auch intravesikale Monotherapie-Anwendungen bewerten sowie eine Kombinationstherapie mit einem Anti-PD-1-Checkpoint-Inhibitor. Ziel der Forschung ist es, translationalen Daten zu erzeugen, um die künftige klinische Entwicklung zu steuern und breitere Anwendungen der Immuno-Onkologie zu unterstützen. Die Ergebnisse werden voraussichtlich im ersten Quartal 2026 vorliegen. Die Studienergebnisse könnten die Erweiterung des Investigational New Drug-Antrags für PV-10 sowohl für sitzspezifische als auch eine systemische Verabreichung ermöglichen.
أصدرت شركة Provectus Biopharmaceuticals (OTCQB: PVCT) دراسة قبل السريرية لدوائها الرائد PV-10 لعلاج سرطان المثانة. ستقيم الدراسة، التي أجرتها TD2، كلاً من استخدامه كوحيد فموي وكتطبيق داخلي في المثانة، بالإضافة إلى العلاج المركّب مع مثبِّط نقطة تفتيش anti-PD-1. تهدف الأبحاث إلى توليد بيانات ترجمةية توجه التطوير السريري المستقبلي وتدعم تطبيقات أوسع في Immuno-oncology. من المتوقع الحصول على النتائج في الربع الأول من 2026. قد تسمح نتائج الدراسة بتوسيع طلب نقل دواء PV-10 (Investigational New Drug) ليشمل الإعطاء الموضعي والsystemic.
Provectus Biopharmaceuticals (OTCQB: PVCT) 已启动其主药 PV-10 用于膀胱癌治疗的前临床研究。该研究由 TD2 进行，将评估口服单药和膀胱内单药治疗以及与 anti-PD-1 免疫检查点抑制剂的联合治疗。研究旨在产生转化数据，以指导未来的临床发展并支持更广泛的免疫治疗应用。预计结果将在 2026 年第一季度公布。该研究结果可能使 PV-10 的调查性新药申请在部位特异给药和全身给药方面获得扩展。
- Potential expansion of PV-10's application to include both site-specific and systemic administration
- Study includes multiple treatment approaches (oral, intravesical, and combination therapy)
- Partnership with established research organization TD2 and City of Hope Cancer Center
- Results not expected until Q1 2026
- Early-stage preclinical study with no guaranteed success
- Multiple regulatory approvals still needed before commercialization
KNOXVILLE, Tenn., Sept. 29, 2025 (GLOBE NEWSWIRE) -- Provectus Biopharmaceuticals, Inc. (“Provectus” or the “Company”) (OTCQB: PVCT) today announced the start of a preclinical study of its lead investigational drug PV-10 in an orthotopic bladder cancer model. Results are expected in the first quarter of 2026. PV-10 is formulated from the Company’s pharmaceutical-grade rose bengal sodium active pharmaceutical ingredient.
Conducted by Translational Drug Development, LLC (TD2), the study will evaluate PV-10’s performance across different treatment arms, including oral and intravesical monotherapy and combination with an anti-PD-1 checkpoint inhibitor. The study is designed to generate translational data that would inform future clinical development of PV-10 for bladder cancer and support broader immuno-oncology applications of oral PV-10 for solid tumor cancers.
Alan Bryce, MD, Interim President and Chief Clinical Officer, City of Hope Cancer Center Phoenix said, “Our goal is to be able to translate successful mouse model data into the foundation for a corresponding clinical trial of PV-10 in bladder cancer, with the key being to have an evidence basis for dose and route of administration determinations.”
Dominic Rodrigues, President and Vice Chair of the Board of Directors of Provectus, said “Successful results from this preclinical research will allow us to expand PV-10’s investigational new drug application for site-specific and systemic administration. We believe oral PV-10 has the potential to be a game-changing treatment across solid tumor and hematologic cancers.”
About Provectus
Provectus Biopharmaceuticals, Inc. is a clinical-stage biotechnology company developing a pipeline of immunotherapy medicines based on rose bengal sodium, a first-in-class synthetic small molecule from the halogenated xanthene family. The Company’s clinical programs span oncology, dermatology, and ophthalmology, with additional proof-of-concept programs in hematology, wound healing, infectious diseases, and tissue repair.
For more information, visit www.provectusbio.com.
Forward Looking Statements
The information in this press release may include “forward-looking statements,” within the meaning of the Private Securities Litigation Reform Act of 1995, relating to the business of Provectus and its affiliates, which are based on currently available information and current assumptions, expectations, and projections about future events and are subject to a variety of risks and uncertainties and other factors that could cause actual events or results to differ materially from those projected in the forward-looking statements. Forward-looking statements are often, but not always, identified by the use of words such as “aim,” “likely,” “outlook,” “seek,” “anticipate,” “budget,” “plan,” “continue,” “estimate,” “expect,” “forecast,” “may,” “will,” “would,” “project,” “projection,” “predict,” “potential,” “targeting,” “intend,” “can,” “could,” “might,” “should,” “believe,” and similar words suggesting future outcomes or statements regarding an outlook.
The safety and efficacy of the agents and/or uses under investigation have not been established. There is no guarantee that the agents will receive health authority approval or become commercially available in any country for the uses being investigated or that such agents as products will achieve any particular revenue levels.
Due to the risks, uncertainties, and assumptions inherent in forward-looking statements, readers should not place undue reliance on these forward-looking statements. The forward-looking statements contained in this press release are made as of the date hereof or as of the date specifically specified herein, and Provectus undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except in accordance with applicable securities laws. The forward-looking statements are expressly qualified by this cautionary statement.
Risks, uncertainties, and assumptions include those discussed in the Company’s filings with the Securities and Exchange Commission (SEC), including those described in Item 1A of:
- The Company’s Annual Report on Form 10-K for the period ended December 31, 2024, and
- Provectus’s Quarterly Report on Form 10-Q for the period ended June 30, 2025.
Contacts:
Provectus Biopharmaceuticals, Inc.
Heather Raines, CPA
Chief Financial Officer
(866) 594-5999
Investor Relations & Media
Susan Xu
sxu@allianceadvisors.com
(778) 323-0959
FAQ
What is the purpose of Provectus Biopharmaceuticals' new PV-10 preclinical study?
When will PVCT's PV-10 bladder cancer study results be available?
What are the potential applications of PV-10 according to Provectus (PVCT)?
Who is conducting Provectus Biopharmaceuticals' PV-10 bladder cancer study?
What formulation is PVCT's PV-10 made from?
