KNOXVILLE, TN, Nov. 13, 2023 (GLOBE NEWSWIRE) — Provectus (OTCQB: PVCT) today provided updated data from an ongoing Phase 1 clinical trial of investigational cancer immunotherapy PV-10 (rose bengal sodium) for the treatment of uveal melanoma (UM) metastatic to the liver (mUM) (NCT00986661).
mUM patients enrolled in this study received 1 or more cycles of PV-10 injection into 1 or more hepatic metastases. Where indicated, standard of care immune checkpoint blockade (CB), as either monotherapy pembrolizumab or the combination of ipilimumab and nivolumab (IN), was also administered.
To date, 25 mUM patients have received monotherapy PV-10 or PV-10 in combination with CB:
- Median age 64.3 years, range 32-80,
- 14 male (56%), 11 female (44%),
- 17 Stage M1a (68%), 7 M1b (28%), 1 M1c (4%),
- Median of 1 line of prior therapy for metastatic disease,
- 12 patients were CB-refractory (48%),
- 16 patients received ≥2 treatment cycles of PV-10 (64%),
- Median of 2 hepatic lesions were injected per patient (range 1-10), and
- 11 patients received CB of IN concurrent with or after PV-10 (44%).
Acceptable safety was observed, with no mortality or permanent Grade 3 or higher morbidity attributed to study treatment.
Objective response of PV-10-injected hepatic lesions was assessed using 2D-EASL imaging measurement, which accounts for changes in viable and necrotic tumor:
- 1 patient achieved complete response (4%),
- 7 patients achieved partial response (28%); 32% objective response rate, and
- 8 patients achieved stable disease (32%); 64% disease control rate.
Median overall survival (mOS) of all patients was 11.0 months via Kaplan-Meier:
- mOS of all M1a patients was 30.6 months (2.6 years), and
- mOS of M1a patients receiving PV-10 + IN was 50.0 months (4.2 years).
An exploratory assessment of 9 patients by PET-CT revealed durable complete metabolic responses (CMRs) in 4 M1a pts:
- 1 patient received monotherapy PV-10; 3 patients received PV-10 + IN,
- All CMR patients are alive after a median follow-up of 39 months (3.3 years), range 24.6-61.6 months (2.1-5.1 years); mOS has not been reached yet, and
- CMR patients represent 24% of M1a patients and 16% of all patients.
Dominic Rodrigues, Vice Chair of the Provectus’s Board of Directors, said, “Objective response is uncommon and complete metabolic response is rare in metastatic uveal melanoma. PET-CT is not routinely used in this disease; however, early confirmation of response by PET-CT in several subjects suggested its potential importance, and it has since proven valuable for following disease course and documenting durability of response. To confirm these initial results, additional M1a patients in a dedicated study cohort will receive PV-10 in combination with standard of care ipilimumab and nivolumab, as well as comprehensive surveillance by PET-CT and expanded immune correlative assessment.”
About Provectus
Provectus Biopharmaceuticals, Inc. (Provectus or the Company) is a clinical-stage biotechnology company developing immunotherapy medicines for different diseases that are based on a class of synthetic small molecule immuno-catalysts called halogenated xanthenes (HXs). Provectus’s lead HX molecule is named rose bengal sodium (RBS).
The Company’s proprietary, patented, pharmaceutical-grade RBS is the active pharmaceutical ingredient (API) in the drug product candidates of Provectus’s clinical development programs and preclinical formulations of the Company’s drug discovery programs. Provectus’s 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 Expert Committee of the World Health Organization selected “rose bengal sodium” for the nonproprietary name of the Company’s API.
RBS may target disease in a bifunctional manner. Direct contact may lead to cell death or repair depending on the disease being treated and the concentration of Provectus’s RBS utilized in the treatment. Multivariate immune signaling, activation, and response may follow that may manifest as stimulatory, inhibitory, or both.
The Company believes that it is the first entity to advance an RBS formulation into clinical trials for the treatment of a disease. Provectus believes that it is the first and only entity to date to make pharmaceutical-grade RBS successfully, reproducibly, and consistently at a purity of nearly 100%.
Provectus’s small molecule HX medical science platform includes clinical development programs in oncology, dermatology, and ophthalmology; proof-of-concept in vivo development programs in oncology, hematology, wound healing, and animal health; and in vitro drug discovery programs in infectious diseases and tissue regeneration and repair.
Information about the Company’s clinical trials can be found at the National Institutes of Health (NIH) registry, 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, 2022, and
- Provectus’s Quarterly Report on Form 10-Q for the period ended June 30, 2023.
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Contact:
Provectus Biopharmaceuticals, Inc.
Heather Raines, CPA
Chief Financial Officer
Phone: (866) 594-5999
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