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Provectus Biopharmaceuticals Presents Data from PV-10® Treatment of Metastatic Uveal Melanoma Patients in Two Oral Presentations at 2022 International Society of Ocular Oncology (ISOO) Congress

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Provectus (OTCQB: PVCT) announced updated data from its Phase 1 trial targeting metastatic uveal melanoma (mUM) patients treated with the investigational immunocatalyst PV-10. Presented at the 20th Congress of the International Society of Ocular Oncology in June 2022, findings highlighted successful responses in patients receiving PV-10 injections. The study allows for multiple tumor injections per treatment cycle with assessments every three months. Provectus continues to develop various immunotherapy medicines, focusing on oncology and other disease areas.

Positive
  • Updated data showcases effective response rates in metastatic uveal melanoma patients treated with PV-10.
  • Presentations at an esteemed oncology congress enhance visibility and credibility for Provectus.
  • Ongoing clinical trial suggests potential for further investigations with immune checkpoint blockade.
Negative
  • None.

KNOXVILLE, TN, June 30, 2022 (GLOBE NEWSWIRE) -- Provectus (OTCQB: PVCT) today announced that updated data from the Company’s initial expansion cohort of patients with uveal melanoma metastatic to the liver (mUM) in its cancers-of-the-liver Phase 1 trial of investigational immunocatalyst PV-10 (NCT00986661) were part of two oral presentations at the 20th Congress of the International Society of Ocular Oncology (ISOO), held June 17-21, 2022 in Leiden, The Netherlands.

The first presentation, given by Krysta McVay, Research Nurse, Department of Melanoma Medical Oncology, Division of Cancer Medicine at MD Anderson Cancer Center (MDACC), was entitled “A phase 1 study of percutaneous autolytic rose bengal disodium for metastatic uveal melanoma patients with hepatic metastases.” A copy of her presentation is available on Provectus’ website at: https://www.provectusbio.com/media/docs/publications/ISOO_PV-10_McVay-2022.pdf.

Sapna Patel, MD, Associate Professor, Department of Melanoma Medical Oncology, Division of Cancer Medicine and Director of the Uveal Melanoma Program at MDACC and Chair, Melanoma Committee, SWOG Cancer Research Network, made the second presentation entitled “Metabolic complete responses (mCR) in metastatic uveal melanoma (mUM) patients treated with image-guided injection of PV-10.” A copy of her presentation is available on the Company’s website at: https://www.provectusbio.com/media/docs/publications/ISOO_PV-10_mCR_Patel.ew16Jun22_v4.pdf.

This ongoing single-center mUM study at MDACC has been led since inception by Dr. Patel. Up to three hepatic mUM tumors can be injected per PV-10 treatment cycle. Response assessments are performed at Day 28, and then every three months. Patients with additional, injectable, visceral hepatic mUM disease may receive additional cycles of PV-10 after Day 28. Eligible patients may also receive standard of care immune checkpoint blockade during and after PV-10 treatment.

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 RBS. 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, virology, microbiology, ophthalmology (clinical-stage), and animal health, 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:

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Contact:

Provectus Biopharmaceuticals, Inc.
Heather Raines, CPA
Chief Financial Officer
Phone: (866) 594-5999


FAQ

What recent data has Provectus released regarding PV-10?

Provectus released updated data showing effective response rates for PV-10 in metastatic uveal melanoma patients during a recent oncology congress.

When was the PV-10 data presented?

The PV-10 data was presented at the 20th Congress of the International Society of Ocular Oncology from June 17-21, 2022.

What is the focus of Provectus' Phase 1 trial?

The Phase 1 trial focuses on patients with metastatic uveal melanoma (mUM) treated with the investigational immunocatalyst PV-10.

What is the significance of the presentations made by Provectus at the congress?

The presentations provide visibility to Provectus’ ongoing research efforts and the potential effectiveness of PV-10 in treating metastatic uveal melanoma.

What are the treatment cycles like for patients in the Provectus study?

Patients in the study may receive multiple injections of PV-10 per treatment cycle, with response assessments conducted after 28 days and then every three months.

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