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
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:
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)
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
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.
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.
PV-10® is a registered trademark of Provectus Pharmatech, Knoxville, Tennessee, USA
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Provectus Biopharmaceuticals, Inc.
Heather Raines, CPA
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