Provectus Biopharmaceuticals Launches Veripure™, an Open Science Program for Medical Research Access to PV-10 (rose bengal sodium)
- Under Veripure, Provectus is supplying qualified medical researchers with the same pharmaceutical grade rose bengal sodium API used in clinical trials.
- Veripure is also a quality benchmark, distinguishing program-associated medical research on PV-10 from research conducted using commercially sourced rose bengal of variable purity and uncharacterized content.
- Provectus has supplied PV-10 to independent researchers in the United States, Canada, Australia, and France.
KNOXVILLE, Tenn., June 25, 2026 (GLOBE NEWSWIRE) -- Provectus Biopharmaceuticals, Inc. (“Provectus” or the “Company”) (OTCQB: PVCT), a clinical-stage biotechnology company developing pharmaceutical grade rose bengal sodium (“RBS”) active pharmaceutical ingredient (“API”) as a platform therapeutic, today announced the launch of its Veripure™ open science research program. Veripure makes PV-10, formulated from pharmaceutical-grade RBS API, freely available to qualified researchers globally without restrictive constraints on study direction, design, or findings. Researchers interested in studying RBS for therapeutic applications through the Veripure program are invited to contact Provectus directly at veripure@pvct.com.
Veripure: Open Science Research as a Therapeutic Platform Building Strategy
Provectus has supplied PV-10 to independent researchers studying different diseases, such as in oncology, dermatology, hematology, ophthalmology, infectious disease, wound healing, and tissue repair and regeneration, in sponsored and non-sponsored settings, including:
- The United States: MD Anderson Cancer Center (Houston, TX), Moffitt Cancer Center (Tampa, FL), The Rockefeller University (New York, NY), Bascom Palmer Eye Institute, University of Miami (FL), University of Illinois at Chicago, University of Nevada, Las Vegas, College of Pharmacy at the University of Tennessee Health Science Center (Memphis), University of Texas Medical Branch at Galveston, Center for Interventional Oncology at the National Institutes of Health Clinical Center (Bethesda, MD), and a leading pediatric cancer research hospital,
- Canada: Cumming School of Medicine at the University of Calgary and Vaccine and Infectious Disease Organization at the University of Saskatchewan,
- Australia: The University of Queensland and University of New South Wales, and
- France: University of Lille.
The Veripure name reflects something more fundamental than a supply arrangement. Scientists and physician-researchers who obtain PV-10 through the Veripure program receive research material formulated from the same pharmaceutical-grade RBS API used in Provectus clinical trials. Commercially sourced (i.e., commercial grade) rose bengal can vary significantly in purity, content profile, and batch-to-batch consistency. That difference is not incidental. Research findings generated from non-pharmaceutical grade rose bengal may be less reproducible, less clinically translatable, and less scientifically meaningful than findings generated with PV-10. Veripure closes that gap deliberately. When an independent researcher using Veripure-supplied PV-10 arrives at a finding, that result may be more of a direct bridge between bench and bedside than findings from research using commercially sourced rose bengal.
The Veripure program imposes no publication controls, no strict data-sharing requirements, and no indication restrictions as conditions of PV-10 supply. That relationship structure is a deliberate expression of Provectus’s confidence in RBS medical science and in RBS API. It distinguishes Veripure-associated research presentations and publications from rose bengal biomedical literature conducted with commercially sourced material.
Dominic Rodrigues, Provectus’s President and Vice Chairman of its Board of Directors, said, “Our evidence-based conviction about RBS medical science is strong enough that we actively want researchers who we do not sponsor to ask questions that we did not commission and to arrive at whatever conclusions their data support. When independent researchers working from their own hypotheses in whatever disease they are studying arrive at findings consistent with our emerging universal mechanistic framework for RBS without having been directed toward it, that is a different level of scientific validation. We want more of it, and Veripure is how we make more of it possible.”
RBS API and PV-10 Drug Candidate
Provectus’s RBS API and PV-10 drug product candidate manufacturing processes employ Quality-by-Design principles and follow current good manufacturing practice regulations (“cGMP”) and guidelines of The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use. These processes utilize controls that eliminate the formation of historical impurities and avoid the introduction of potentially hazardous impurities that the Company believes may have been and could be present in uncontrolled and unreported amounts in commercially sourced rose bengal.
The Company’s pharmaceutical-grade RBS API resulted from:
- Provectus’s innovation of a proprietary, patented, commercial-scale process to synthesize the RBS molecule into a viable API for commercial pharmaceutical use,
- The development of unique chemistry, manufacturing, and control (“CMC”) specifications for API and drug candidate manufacturing processes,
- Production and multi-year stability testing of multiple lots of RBS API and PV-10 drug candidate,
- Comprehensive documentation of lot composition and reproducibility, and
- Review and acceptance of CMC data by national drug regulatory agencies for use in a late stage clinical study.
These processes and stability lot data were reviewed prior to granting clinical trial authorizations for a historical Phase 3 randomized control trial of intralesional PV-10 for the treatment of locally advanced cutaneous melanoma, Provectus’s former lead indication, by:
- U.S. FDA,
- Germany’s Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM),
- Australia’s Therapeutic Goods Administration (TGA), under a clinical trial notification,
- France’s Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM),
- Italy’s Agenzia Italiana del Farmaco (AIFA),
- Mexico’s Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS), and
- Argentina’s Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT).
RBS Non-Proprietary Name
The RBS name for Provectus’s pharmaceutical grade API was selected by and passed the review of the World Health Organization (“WHO”) Expert Advisory Panel on the International Pharmacopoeia and Pharmaceutical Preparations after the Company applied for a non-proprietary name in 2020 and reached the status of recommended International Non-proprietary Names (“INN”). INN Recommended List 88, which includes the RBS name, was published with the No. 3 issue of the WHO Drug Information, Volume 36 in 2022.
Non-Pharmaceutical Grades of Rose Bengal
Commercial grade rose bengal can be purchased from specialty chemical suppliers in the U.S. and other parts of the world. It appears to have reported purities that vary substantially and may contain substantial amounts of unreported impurities and/or gross contaminants. By contrast, Provectus’s pharmaceutical-grade RBS API is manufactured to a much higher, defined, controlled purity specification with characterized impurity limits documented in its CMC specifications. Commercial grade rose bengal is typically used by medical researchers unaffiliated with the Company for non-clinical study of the rose bengal molecule for potential therapeutic applications. Provectus believes that commercial grade rose bengal is still manufactured using the original historical process developed by the molecule’s creator and Swiss chemist Robert Gnehm in 1882, or a variant thereof. Some chemical manufacturers may, however, apply purification techniques that the Company believes still result in commercial grade rose bengal possessing questionable purity, related and unrelated contaminants, and/or substantial lot-to-lot manufacturing variability.
Diagnostic grade rose bengal describes non-approved rose bengal that is used as an ingredient in historical or current ophthalmic diagnostic solutions, strips, and devices, that has been historically or is presently compounded by pharmacists for ophthalmic use, and that has been or is in non-ophthalmic diagnostic tests such as the rose bengal test for human brucellosis. Diagnostic grade rose bengal may be derived from commercial grade rose bengal that may have undergone a form of purification under cGMP regulations and/or may have been compounded by a pharmacist, academic medical researcher, or commercial entity under cGMP regulations. Here too, the Company believes that purification alone may not sufficiently improve the amounts and accuracy of diagnostic grade rose bengal purity and lot contents and may not adequately reduce or eliminate lot-to-lot manufacturing variability.
Chemical Analytical Comparison
In 2022, the Company worked with a U.S. contract development and manufacturing organization to assess lots of commercial grade rose bengal from different specialty chemical suppliers and to compare these non-pharmaceutical grade materials with the Company’s pharmaceutical grade RBS. The results of these analyses indicate that all lots of commercial grade rose bengal had purity that was substantially different from what was noted on their respective certificates of analysis (“CofAs”) and that one of the lots contained gross contaminants that were not noted on its CofA.
Potential Barriers to Entry
Provectus believes that the Company's proprietary pharmaceutical-grade RBS API possesses competitive advantages over non-pharmaceutical-grade rose bengal that researchers, clinicians, and academic, business, and/or governmental entities have used, are using, and/or may attempt to use to develop potential therapeutic applications. Provectus believes that non-pharmaceutical-grade rose bengal may suffer from the uncontrolled presence of substance-related impurities and/or gross contaminants, substantial lot-to-lot manufacturing variability, inaccurately reported purity and contents, and lack of reproducible, consistent, and fulsome CMC specifications and documentation. The Company believes that historical and potentially hazardous impurities and other manufacturing and handling issues facing non-pharmaceutical grade rose bengal may pose significant scientific, technological, and economic challenges to overcome and validate for compliance with modern drug regulatory standards.
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, tissue repair, and neurodegeneration.
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, including those described in Item 1A of the Company’s Annual Report on Form 10-K for the period ended December 31, 2025 and Quarterly Report on Form 10-Q for the period ended March 31, 2026.
Contacts:
Provectus Biopharmaceuticals, Inc.
Heather Raines, CPA
Chief Financial Officer
hraines@pvct.com
(866) 594-5999
Investor Relations & Media
Susan Xu
sxu@allianceadvisors.com
(778) 323-0959
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