KNOXVILLE, TN, Nov. 15, 2023 (GLOBE NEWSWIRE) -- Provectus (OTCQB: PVCT) today provided updated data from an ongoing Phase 1b/2 clinical trial of investigational cancer immunotherapy PV-10 (rose bengal sodium) in combination with standard of care immune checkpoint blockade (CB) for the treatment of advanced cutaneous melanoma (NCT02557321).
Initial results from CB-naïve patients in the main study cohort illustrated potential clinical benefit across all stages of metastasis. Longer-term follow-up of an expanded patient population has been assessed.
Participants must have had at least 1 injectable lesion and at least 1 measurable target lesion and been a candidate for pembrolizumab. The combination of PV-10 and pembrolizumab was administered every 3 weeks for up to 5 cycles, followed by pembrolizumab alone every 3 weeks for a total duration of up to 24 months. Patients may have received PV-10 as needed (PRN) beyond the initial treatment course per investigator discretion. The primary endpoint of the Phase 1b portion was safety and tolerability. Objective response rate (ORR) and progression-free survival (PFS) were key secondary endpoints (assessed via RECIST 1.1 after 15 weeks, and then every 12 weeks).
The addition of an expansion cohort balanced overall enrollment at 25 patients:
- Median age 73.0 years, range 28-82,
- 20 male (80%), 5 female (20%), and
- 6 Stage IIIB-IIIC (24%), 8 Stage IV M1a (32%), 7 M1b (28%), 4 M1c (16%) per the American Joint Committee on Cancer (AJCC) melanoma staging system.
Treatment-emergent adverse events were consistent with the established patterns of both study drugs. There was no evidence of overlap.
For all CB-naïve patients:
- ORR was 72%; 20% complete response (CR) and 52% partial response (PR),
- Median PFS (mPFS) was 12.5 months for all patients,
- Median overall survival (mOS) was 37.6 months (3.1 years), and
- Median disease-specific survival (mDSS) was 64.4 months (5.4 years).
For CB-naïve Stage III patients:
- ORR was 83%; 50% CR and 33% PR,
- CRs were rapid and durable, having been reached within 15 weeks by 2 patients and within 27 weeks by the third, and are ongoing after 24-44 months of follow-up,
- mPFS has not been reached,
- mOS is estimated to be 36.3 months (3.0 years),
- mDSS is estimated to be 42.5 months (3.5 years), and
- Both survival metrics could be affected by the status of the last patient in the cohort who is an ongoing complete responder at 30.1 months (2.5 years).
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 September 30, 2023.
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Contact:
Provectus Biopharmaceuticals, Inc.
Heather Raines, CPA
Chief Financial Officer
Phone: (866) 594-5999
