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

Provectus Biopharmaceuticals Inc.

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 (NETs) metastatic to the liver (mNET) refractory to somatostatin analogues (SSA) and peptide receptor radionuclide therapy (PRRT) (NCT02693067) was presented at the annual conference of the European Society of Neuroendocrine Tumors (ENETS), held 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 Queen Elizabeth Hospital (TQEH) in Adelaide, Australia: Tim Price, MBBS, DHlthSc (Medicine), FRACP, Head of Research in Clinical Oncology and Chair of the Hematology and Medical Oncology Unit at TQEH and Clinical Professor at the University of Adelaide Medical School.

Highlights of the ENETS 2022 presentation:

  • Patient characteristics

    • N=12 patients: 50% male; median age of 66 (range 47-79)

    • Primary tumor sites: 7 small intestine (58%), 3 pancreas (25%), 1 cecal (8%) and 1 unknown (8%; probable pancreas)

    • NET scores: 5 1st year (42%) and 7 2nd year (58%)

    • All patients were refractory to SSA (100%) and 11 received PRRT (92%) as part of their prior treatment

    • All patients had progressive symptomatic disease

    • Chromogranin A (CgA) baseline: median 1,585 µg/L (range 35-10,370)

  • PV-10 Treatment

  • Security

    • All treatment-emergent adverse events (TEAEs) were grade 1 or 2, mainly pain at the injection site (75%)

    • Single subjects experienced grade 3 TEAEs of photosensitivity reaction or increased transaminases

  • Efficiency

    • 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 histology of NETs, ​​pancreas vs intestine: mPFS 2.7 months vs 19.7 months; mOS 11.8 months versus 25.5 months

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

Dominic Rodrigues, Vice Chairman of the Company’s Board of Directors, said: “The study data continues to show encouraging local and systemic disease control, as well as symptom control, in a heavily pretreated population and to support the role of PV-10 monotherapy. as a treatment for patients with neuroendocrine cancer who fail standard therapy.

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

About the PV-10

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

Systemic administration of PV-10 is being studied preclinically as prophylactic and therapeutic treatments for high-risk and refractory adult solid tumor cancers, and as a therapeutic treatment for recurrent blood cancers and refractories.

About Provectus

Provectus Biopharmaceuticals, Inc. (Provectus or the Company) is a clinical-stage biotechnology company that develops immunotherapy drugs for different disease areas based on a family of small molecules called halogenated xanthenes. Multi-route drug discovery and development programs include investigational drugs and drug targets in oncology (clinical stage), dermatology (clinical stage), hematology, virology, microbiology, ophthalmology (clinical stage clinic) and animal health. Information about the Company’s clinical trials is available on the National Institutes of Health (NIH) registry, www.clinicaltrials.gov. For more information about Provectus, please visit the company’s website at www.provectusbio.com.

Trademarks

PV-10® is a registered trademark of Provectus Pharmatech, Knoxville, Tennessee, USA

FORWARD-LOOKING STATEMENTS: Information in this press release may include “forward-looking statements”, within the meaning of United States securities laws, relating to the business of Provectus and its affiliates, which are based on the opinions and estimates of the management of the Company and are subject to various 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”, “plan”, “may”, “will”, “project”, “predict”, ” potential”, “targeting”, “intent”, “could”, “could”, “should”, “believe” and similar words suggesting future results or statements about a prospect.

The safety and effectiveness of the agents and/or uses under investigation have not been established. There is no guarantee that agents will receive health authority approval or be commercially available in a country for the uses investigated or that these agents as products will achieve 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 new information, future events or otherwise, except in accordance with applicable securities laws. Forward-looking statements are expressly qualified by this cautionary statement.

The 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
Financial director
Phone: (866) 594-5999

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