Provectus Biopharmaceuticals Announces World Health Organization Selection of “Rose Bengal Sodium” as International Nonproprietary Name for Active Pharmaceutical Ingredient
Provectus (OTCQB: PVCT) announced that the World Health Organization's INN Expert Committee has selected "rose bengal sodium" as the official nonproprietary name for its active pharmaceutical ingredient. This designation follows a public consultation and signifies a step towards enhanced regulatory oversight. Provectus claims to be the first to produce pharmaceutical-grade RBS with nearly 100% purity, utilizing a patented commercial-scale synthesis process. The company views this milestone as crucial for advancing its clinical development and drug discovery programs.
- Selection of 'rose bengal sodium' as nonproprietary name enhances regulatory clarity.
- Provectus is the first to achieve nearly 100% purity in pharmaceutical-grade RBS.
- Successful development of a patented commercial-scale synthesis process.
- None.
KNOXVILLE, TN, Nov. 02, 2022 (GLOBE NEWSWIRE) -- Provectus (OTCQB: PVCT) today announced that the International Nonproprietary Names (INN) Expert Committee of the World Health Organization (WHO) has selected “rose bengal sodium” (RBS) for the nonproprietary name of the Company’s active pharmaceutical ingredient (API). Pharmaceutical-grade RBS is the API in Provectus’ current clinical-stage drug product candidates and preclinical formulations.
The RBS name was selected by the WHO Expert Advisory Panel on the International Pharmacopoeia and Pharmaceutical Preparations, reached the status of recommended INN after a period of public consultation, and was included in INN Recommended List 88 published with the No. 3 issue of the WHO Drug Information, Volume 36 in October 2022.
The aim of the INN system since inception has been to provide health professionals with a unique and universally available designated name to identify each pharmaceutical substance or API, according to the WHO. The existence of an international nomenclature in the form of INN is important for the accurate identification, prescribing, and dispensing of medicines to patients, and for communication and exchange of information among health professionals and scientists worldwide.
Provectus is the first and only entity to have made pharmaceutical-grade RBS at a purity of nearly
- The innovation of a proprietary, patented, commercial-scale process to synthesize and utilize the RBS molecule as a viable drug substance for commercial use;
- The development of unique chemistry, manufacturing, and control (CMC) specifications for drug substance and investigational drug product manufacturing processes;
- The production and multi-year stability testing of multiple drug substance and investigational drug product lots;
- The comprehensive documentation of lot composition and reproducibility; and
- The review and acceptance of CMC data from these lots by seven national drug regulatory authorities for a prior, global, multi-center, pivotal Phase 3 clinical trial.
Dominic Rodrigues, Vice Chair of Provectus’ Board of Directors, said “The World Health Organization’s International Nonproprietary Names system has facilitated the name of rose bengal sodium for the active pharmaceutical ingredient that is the foundation of our clinical development and drug discovery programs comprising a number of different disease areas. We believe that finalizing this name is an important step towards enabling drug regulatory agencies to ensure strong pharmacovigilance of rose bengal sodium in medicines.”
Mr. Rodrigues added, “Provectus recognizes the significant body of international research into non-pharmaceutical grades of rose bengal for the treatment of other diseases. We strongly encourage collaboration with Provectus to facilitate the development of more investigational drug product candidates that utilize our pharmaceutical-grade rose bengal sodium to advance new treatment concepts from laboratory bench to patient bedside.”
About Provectus
Provectus Biopharmaceuticals, Inc. (Provectus or the Company) is a clinical-stage biotechnology company developing immunotherapy medicines for different disease areas based on a class of small molecules called halogenated xanthenes (HXs). The Company’s lead molecule is rose bengal sodium. A second HX molecule has been synthesized.
Provectus’ drug discovery and development programs include investigational drugs and drug targets in oncology (clinical-stage), dermatology (clinical-stage), hematology, infectious diseases, ophthalmology (clinical-stage), animal health, tissue regeneration and repair, and wound healing, and use multiple routes of administration, such as intralesional (IL), topical (.top), oral (P.O.), inhaled (.inh), intranasal (IN), and intravenous (IV).
Information about the Company’s clinical trials can be found at the National Institutes of Health (NIH) registry, www.clinicaltrials.gov. For additional information about Provectus, please visit the Company's website at www.provectusbio.com.
FORWARD-LOOKING STATEMENTS: The information in this press release may include “forward-looking statements,” within the meaning of U.S. securities legislation, relating to the business of Provectus and its affiliates, which are based on the opinions and estimates of Company management 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 “seek,” “anticipate,” “budget,” “plan,” “continue,” “estimate,” “expect,” “forecast,” “may,” “will,” “project,” “predict,” “potential,” “targeting,” “intend,” “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, 2021, and
- Provectus’ Quarterly Report on Form 10-Q for the period ended June 30, 2022.
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Contact:
Provectus Biopharmaceuticals, Inc.
Heather Raines, CPA
Chief Financial Officer
Phone: (866) 594-5999
FAQ
What is the significance of the INN designation for Provectus' rose bengal sodium?
When was 'rose bengal sodium' selected as the nonproprietary name?
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How does Provectus plan to use rose bengal sodium in drug development?
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