Provectus Biopharmaceuticals Announces Presentation of Full Study Data from Metastatic Neuroendocrine Cancer Phase 1 Trial of PV-10® at European Society for Medical Oncology (ESMO) Congress 2021

Rhea-AI Summary

Provectus (OTCQB: PVCT) presented data from an ongoing clinical trial of PV-10 for treating metastatic neuroendocrine tumors at the ESMO Congress (Sept 16-21, 2021). The trial involved 12 patients, showing an objective response rate of 42% and a disease control rate of 83%. Median progression-free survival was 9.2 months, with overall survival at 22.5 months. Notable adverse effects included injection site pain in 75% of patients. The CEO expressed optimism regarding PV-10’s potential in refractory cases and future Phase 2 testing. Data collection is expected to finalize in Q4 2021.

Positive

• 42% objective response rate (ORR) observed in the trial.
• 83% disease control rate (DCR) among patients.
• Median progression-free survival of 9.2 months.
• Median overall survival at 22.5 months.

Negative

• Injection site pain experienced by 75% of patients.
• Grade 3 adverse reactions reported in some patients.

KNOXVILLE, TN, Sept. 21, 2021 (GLOBE NEWSWIRE) -- Provectus (OTCQB: PVCT) today announced that data from an ongoing clinical trial of investigational cancer immunotherapy PV-10 (rose bengal disodium) 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 European Society for Medical Oncology (ESMO) Congress, held online from September 16-21, 2021.

Highlights from the ESMO 2021mNET Presentation:

• Baseline disease characteristics
  • N = 12 patients: 50% male; median age of 66 years (range 47-79)
  • Primary tumor sites: 7 small bowel (58%), 2 pancreas (17%), 1 caecal (8%), and 2 unknown (17%)
  • NET grades: 5 Grade 1 (42%) and 7 Grade 2 (58%)
  • Refractory to SSA and PRRT; all symptomatic progressive disease
  • Chromogranin A (CgA): median 1,585 μg/L (35-10,370)
• PV-10 treatment
  • Median number of injected lesions: 1 (1-4)
  • Median number of injection cycles: 1 (1-4); 8 patients (67%) received 1 PV-10 cycle; 4 patients received multiple cycles
• Safety
  • Injection site pain in 9 of 12 patients (75%)
  • Grade 3 photosensitivity reaction in 1 patient; Grade 3 elevation of hepatic enzymes in 1 patient (resolved by Day 7); carcinoid flare in 2 patients
• Injected-lesion efficacy (RECIST)
  • 42% partial response (PR) and 42% objective response rate (ORR)
• Patient-level efficacy (RECIST)
  • 83%^a disease control rate (DCR) (10 of 12 patients)
  • Median progression-free survival (PFS): 9.2 months (1.0-41.8)
  • Median overall survival (OS): 22.5 months (5.5-41.8); 6 patients (50%) undergoing response follow-up (data cut-off: April 30, 2021)
• Immune response
  • Upregulation of NK cells and activated CD4+ T cells observed in peripheral blood collected 7-28 days post-PV-10 injection
• Biomarkers and quality of life (QOL)
  • CgA stable in 10 patients (83%)
  • Health-related QOL assessments stable or improved at one month in 8 of 11 patients (73%); maintained at 3 months in 6 of 10 patients (60%)
    

^a Typographical error on the poster

A copy of the poster is available on Provectus’ website at https://www.provectusbio.com/media/docs/publications/Phase_1_NET.ESMO-2021.pdf.

Simone Leyden, Chief Executive Officer and Co-Founder of NeuroEndocrine Cancer Australia, and International Neuroendocrine Cancer Alliance (INCA) Research Chair, said “The safety and efficacy data from this Phase 1 clinical trial of single-agent PV-10 present a promising therapy for refractory, symptomatic, neuroendocrine cancer patients with liver metastases, a patient population who are underrepresented when it comes to new medical research and treatment options. We look forward to seeing PV-10’s future use in this refractory setting, and also in Phase 2 combination therapy testing for earlier lines of neuroendocrine cancer treatment.”

Dominic Rodrigues, Vice Chair of the Company’s Board of Directors, added, “These data may initially position single-agent PV-10 behind somatostatin analogs and peptide receptor radionuclide therapy in the Australian patient treatment setting. Our clinical trial database should lock in the fourth quarter of 2021, providing us the opportunity to finalize data collection and analysis prior to assessing PV-10’s regulatory prospects and options.”

This clinical trial, a single-center study at The Queen Elizabeth Hospital (TQEH) in Adelaide, Australia that completed enrollment in 2020, is led by 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. The primary endpoint of the trial is safety. Secondary endpoints include ORR of injected target and measurable bystander lesions, target lesion somatostatin receptor expression, and biochemical response. Disease response assessments are conducted by independent review using Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Six patients in the first cohort each received one percutaneously-administered injection of PV-10 to one target lesion per treatment cycle. Patients in the six-person second cohort can receive PV-10 injections of multiple lesions per cycle.

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 IL PV-10-induced functional T cell response may be enhanced and boosted in combination with immune checkpoint blockade (CB). In CB-refractory advanced cutaneous melanoma, IL PV-10 may restore disease-specific T cell function, which may also be prognostic of clinical response. IL PV-10 has been administered to over 450 patients with cancers of the skin and of the liver. It is administered under visual, tactile or ultrasound guidance to superficial malignancies, and under CT or ultrasound guidance to tumors of the liver. Systemic administration of PV-10 is also undergoing preclinical study as prophylactic and therapeutic treatments for refractory and high-risk adult solid tumor cancers, and as a treatment for relapsed and refractory blood cancers.

About NeuroEndocrine Cancer Australia

NeuroEndocrine Cancer Australia is the only Australian not-for-profit medical charity focused on neuroendocrine tumors. It was co-founded in 2009 by Simone Leyden and her brother Dr. John Leyden through shared experiences with their sister Kate’s diagnosis of pancreatic neuroendocrine carcinoma and liver metastases. For more information, please visit NeuroEndocrine Cancer Australia’s website at www.neuroendocrine.org.au.

About Provectus

Provectus Biopharmaceuticals, Inc. (Provectus or the Company) is a clinical-stage biotechnology company developing immunotherapy medicines for different disease areas based on an entirely- and wholly-owned family of small molecules called halogenated xanthenes. 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.

Trademark

PV-10^® is registered trademark of Provectus, 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 June 30, 2021.

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Contact:

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

FAQ

What were the results of the PV-10 clinical trial presented by Provectus at ESMO 2021?

The clinical trial showed a 42% objective response rate and an 83% disease control rate among patients treated with PV-10.

How many patients were involved in the PV-10 trial for neuroendocrine tumors?

The trial involved 12 patients in total.

What is the median overall survival reported in the PV-10 trial?

The median overall survival reported was 22.5 months.

What adverse effects were noted in the PV-10 trial?

75% of patients experienced injection site pain, and there were reports of Grade 3 adverse reactions.

When is the data collection expected to finalize for the PV-10 trial?

Data collection is expected to finalize in the fourth quarter of 2021.