お知らせ • Jun 26
Provectus Biopharmaceuticals, Inc. Launches Veripure Open Science Program For Medical Research Access To PV-10
Provectus Biopharmaceuticals, Inc. announced the launch of its Veripure open science research program. Veripure makes PV-10, formulated from pharmaceutical-grade rose bengal sodium API, freely available to qualified researchers globally without restrictive constraints on study direction, design, or findings. 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. 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 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; France: University of Lille. 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 rose bengal can vary significantly in purity, content profile, and batch-to-batch consistency. 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. Provectus’s RBS API and PV-10 drug product candidate manufacturing processes employ Quality-by-Design principles and follow current good manufacturing practice regulations 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 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; 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). The RBS name for Provectus’s pharmaceutical grade API was selected by and passed the review of the World Health Organization 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 Recommended List 88, which includes the RBS name, was published with the No. 3 issue of the WHO Drug Information, Volume 36 in 2022. 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.
