Provectus Biopharmaceuticals Inc (OTCMKTS: PVCT) operating out of Knoxville, Tennessee is a clinical-stage biotechnology company developing immunotherapy medicines for different diseases that are based on a class of synthetic small molecule immuno-modulators called halogenated xanthenes (HXs). Provectus’ lead HX molecule is named rose bengal sodium (RBS). Provectus is the first entity, and the only one to date, to successfully, reproducibly, and consistently make pharmaceutical-grade RBS API at a purity of nearly 100%. The Company believes its small molecule HX medical science platform and associated drug pipeline possess the potential to shape global healthcare and increase global health equity. Provectus holds dear the vision of making the Company’s immunotherapy medicines, when approved, accessible to the tens of millions of patients around the world who suffer from life-altering diseases that Provectus’ drug product candidates may treat. 

Provectus proprietary, patented, pharmaceutical-grade RBS is the active pharmaceutical ingredient (API) in the drug product candidates of Provectus’ clinical development programs and the preclinical formulations of the Company’s drug discovery programs. Importantly, Provectus’ pharmaceutical-grade RBS displays different therapeutic effects at different concentrations and can be formulated for delivery by different routes of administration. The International Nonproprietary Names (INN) Expert Committee of the World Health Organization (WHO) selected “rose bengal sodium” for the nonproprietary name of the Company’s API. 

RBS may target disease in a bifunctional manner. First, direct contact may lead to cell death or repair depending on the disease being treated and the concentration of Provectus’ RBS utilized in the treatment. Secondly, multivariate immune signaling, activation, and response may follow that may manifest as stimulatory, inhibitory, or both. Currently Provectus has established sponsored research collaborations with Moffitt Cancer Center in Tampa, Florida (oncology), The Rockefeller University in New York, New York (dermatology), The Cumming School of Medicine at the University of Calgary in Alberta, Canada (oncology, hematology, vaccines, and infectious diseases), The University of Tennessee Health Science Center in Memphis (infectious diseases).  The College of Veterinary Medicine at the University of Tennessee in Knoxville (animal health), Bascom Palmer Eye Institute at the University of Miami in Florida (ophthalmology), The University of Texas Medical Branch in Galveston (wound healing), and The University of Nevada, Las Vegas (tissue regeneration and repair). 

$PVCT Releases 2023 Stockholder Letter https://t.co/JkO7ssLsGB #rosebengal #rosebengalsodium

— Provectus Biopharmaceuticals, Inc. (@ProvectusBio) January 9, 2023

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Provectus believes that it is the first entity to advance an RBS formulation into clinical trials for the treatment of a disease, such as those trials reported on the clinical trials registry ClinicalTrials.gov. Provectus also believes that it is the first and only entity to date to successfully, reproducibly, and consistently make pharmaceutical-grade RBS at a purity of nearly 100%. 

Provectus’ small molecule HX medical science platform includes clinical development programs in oncology, dermatology, and ophthalmology; proof-of-concept in vivo drug discovery programs in oncology, hematology, wound healing, and animal health; and preclinical in vitro drug discovery programs in infectious diseases and tissue regeneration and repair. 

On December 1 Provecus reported new data from the Company’s ongoing, multi-cohort, Phase 1b/2 study of the combination of small molecule cancer immunotherapy PV-10, an intratumoral formulation of Provectus’ rose bengal sodium (RBS) active pharmaceutical ingredient, and anti-PD-1 therapy Keytruda (pembrolizumab) for the treatment of immune checkpoint blockade (CB)-naïve Stage III cutaneous melanoma (NCT01223415) demonstrated the potential for rapid, durable, complete response in Stage III melanoma patients by combining individually active anticancer agents PV-10 and checkpoint blockade. Intratumoral PV-10 treatment and as-needed retreatment of baseline and any new melanoma lesions use checkpoint blockade to boost the precise, tumor-specific, systemic adaptive immune response generated from the response of PV-10-injected lesions to drive robust patient outcomes. To prove the synergistic clinical benefit of combining PV-10 and checkpoint blockade for the first-line treatment of Stage III melanoma, Provectus  plans to initiate a Phase 2/3 randomized control trial of PV-10 and standard of care checkpoint blockade versus standard of care checkpoint blockade in 2023. This trial is essentially a head-to-head comparison of PV-10 combination therapy and monotherapy Keytruda. 

The Company’s pharmaceutical-grade RBS resulted from (i) the innovation of a commercial-scale process to synthesize and utilize the RBS molecule into a viable API for commercial pharmaceutical use; (ii) the development of unique chemistry, manufacturing, and control (CMC) specifications for drug substance and drug product candidate manufacturing processes; (iii) the production and multi-year stability testing of multiple lots of drug substance and drug product candidate; (iv) the comprehensive documentation of lot composition and reproducibility; and (v) the review and acceptance of CMC data from these lots by seven (7) different national drug regulatory agencies for use in a prior, multi-country, multi-center Phase 3 randomized control trial (RCT) of Provectus. 

$PVCT people are sleeping on this one. pic.twitter.com/qjmiQ7fZol

— Nick Santa (@NickSanta2015) December 5, 2022

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Currently trading at $58 million market valuation PVCT os is 419,497,119 shares with 364,555,776 shares in the public float. PVCT is an exciting biotech that believes its small molecule HX medical science platform and associated drug pipeline such as Rose Bengal Sodium (RBS) possess the potential to shape global healthcare and increase global health equity. PVCT is highly liquid and has quickly attracting a growing shareholder base who are currently bidding the price higher and looking for a move northbound of $0.1895 into a blue-sky breakout. We will be updating on PVCT when more details emerge so make sure you are subscribed to newsytrends.com by entering your email below.

Disclosure: we hold no position in PVCT either long or short and we have not been compensated for this article.