Provectus Biopharmaceuticals Announces Oral Presentation of Updated Study Data from Metastatic Neuroendocrine Cancer Phase 1 Trial of PV-10® at 2022 European Neuroendocrine Tumor Society (ENETS) Annual Conference

Rhea-AI Summary

Provectus (OTCQB: PVCT) presented data from an ongoing clinical trial of its investigational cancer immunotherapy PV-10 for treating metastatic neuroendocrine tumors (mNET) at the ENETS conference.

Involving 12 patients, the study showed a median progression-free survival (mPFS) of 9.4 months and a median overall survival (mOS) of 22.5 months. The safety profile was favorable, with mostly Grade 1 or 2 adverse events. Potential combination therapies could enhance patient outcomes. The findings support PV-10 as a monotherapy option for patients resistant to standard treatments.

Positive

• Median progression-free survival (mPFS) of 9.4 months.
• Median overall survival (mOS) of 22.5 months.
• Encouraging safety profile with mostly Grade 1 or 2 adverse events.
• Potential for combination therapies to improve outcomes.

Negative

• Small sample size of only 12 patients.
• All patients were refractory to prior therapies, limiting broader applicability.

KNOXVILLE, TN, March 16, 2022 (GLOBE NEWSWIRE) -- Provectus (OTCQB: PVCT) today announced that data from an ongoing clinical trial of investigational cancer immunotherapy PV-10 (rose bengal sodium) for the treatment of neuroendocrine tumors (NET) metastatic to the liver (mNET) refractory to somatostatin analogs (SSAs) and peptide receptor radionuclide therapy (PRRT) (NCT02693067) was presented at the annual conference of the European Neuroendocrine Tumor Society (ENETS), held from March 10-11, 2022 in a hybrid setting in Barcelona, Spain and online.

The oral presentation was made by the principal investigator of the clinical trial’s single center at The Queen Elizabeth Hospital (TQEH) in Adelaide, Australia: Tim Price, MBBS, DHlthSc (Medicine), FRACP, Head of Clinical Oncology Research and Chair of the combined Hematology and Medical Oncology Unit at TQEH, and Clinical Professor in the Faculty of Medicine at the University of Adelaide.

Highlights from the 2022 ENETS Presentation:

• Patient characteristics
  • N = 12 patients: 50% male; median age of 66 years (range 47-79)
  • Primary tumor sites: 7 small bowel (58%), 3 pancreas (25%), 1 caecal (8%), and 1 unknown (8%; likely pancreas)
  • NET grades: 5 Grade 1 (42%) and 7 Grade 2 (58%)
  • All patients were refractory to SSA (100%), and 11 received PRRT (92%) as part of their prior treatment
  • All patients had symptomatic, progressive disease
  • Baseline chromogranin A (CgA): median 1,585 µg/L (range 35-10,370)
    
• PV-10 treatment
  
  • 4 patients (33%) received more than 1 dose (range 2-4)
  • 8 patients (67%) received 1 dose
    
• Safety
  
  • All treatment-emergent adverse events (TEAEs) were Grade 1 or 2, primarily injection site pain (75%)
  • Single subjects experienced Grade 3 TEAEs of photosensitivity reaction or transaminases increased
    
• Efficacy
  
  • Median progression-free survival (mPFS): 9.4 months (range 1.0-41.8)
  • Median overall survival (mOS): 22.5 months (range 5.5-42.3); 4 patients alive
  • Subgroup analysis of primary NET histology, pancreas vs intestine: mPFS 2.7 months vs 19.7 months; mOS 11.8 months vs 25.5 months

• Quality of life (QOL) 
  • Stable or improved health status and symptoms after 3 months in most patients

A recording of Dr. Price’s presentation and a copy of his slides are available on Provectus’ website at https://www.provectusbio.com/media/presentation/PV10-ENETS-2022/index.html.

Dominic Rodrigues, Vice Chair of the Company’s Board of Directors, said, “Study data continue to show encouraging local and systemic disease control, as well as symptom control, in a heavily pre-treated population and to support a role for monotherapy PV-10 as a treatment for neuroendocrine cancer patients who fail standard therapy.”

Mr. Rodrigues added, “PV-10-led combination therapies for neuroendocrine cancer patients may represent opportunities to improve quality of life and clinical outcomes. Front-line approaches may include combining liver-directed PV-10 therapy with systemically-delivered immune checkpoint inhibitors to enhance PV-10’s immune mechanisms, or using PV-10 to enhance the activity of cytotoxic treatments such as peptide receptor radionuclide therapy.”

About PV-10

Intralesional (IL) administration of PV-10 for the treatment of solid tumor cancers can yield immunogenic cell death within hours of tumor injection, and induce tumor-specific reactivity in circulating T cells within days. This PV-10-induced functional T cell response may be enhanced and boosted in combination with immune checkpoint blockade (CB). In CB-refractory disease, PV-10 may restore disease-specific T cell function. IL PV-10 has been administered to over 450 patients with melanoma and cancers of the liver in both monotherapy and combination therapy settings. IL PV-10 is administered under visual, tactile, or ultrasound guidance to superficial malignancies, and under CT or ultrasound guidance to visceral hepatic tumors.

Systemic administration of PV-10 is undergoing preclinical study as prophylactic and therapeutic treatments for high-risk and refractory adult solid tumor cancers, and as a therapeutic treatment for relapsed and refractory blood cancers.

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 family of small molecules called halogenated xanthenes. Multi-route of administration 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. 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.

Trademarks

PV-10^® is registered trademark of Provectus Pharmatech, Knoxville, Tennessee, U.S.A.

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 SEC, including those described in Item 1A of the Company’s Annual Report on Form 10-K for the year ended December 31, 2020 and Provectus’ Quarterly Report on Form 10-Q for the quarter ended September 30, 2021.

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Contact:

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

FAQ

What are the results of the PV-10 trial for neuroendocrine tumors?

The trial reported a median progression-free survival of 9.4 months and median overall survival of 22.5 months.

What is the safety profile of PV-10?

Most adverse events were Grade 1 or 2, primarily injection site pain.

What were the patient demographics in the PV-10 trial?

The trial included 12 patients with a median age of 66, split between 50% male and various primary tumor sites.

What future steps are planned for PV-10?

The company is exploring combination therapies with immune checkpoint inhibitors to enhance treatment effectiveness.

How does PV-10 perform in patients previously treated with somatostatin analogs?

All patients in the study were refractory to somatostatin analogs, indicating a need for alternative treatments.