PV-10 for Neuroendicrine Tumors Metastatic to the Liver

Overview

PV-10 is an investigational new drug containing a proprietary injectable formulation of rose bengal disodium, a water-soluble xanthene dye currently in use in a topical opthalmic diagnostic. PV-10 is designed for injection into solid tumors (intralesional administration). Its oncology focus is on melanoma, breast cancer and cancers of the liver. Provectus has received orphan drug designations from the FDA for its melanoma and hepatocellular carcinoma indications.

Status

  • A Phase 1 study was initiated in February 2016.
  • Over 270 cancer patients have been treated with PV-10, including 12 in a Phase 1 recurrent breast cancer study, 6 in a Phase 1 metastatic liver cancer study, 20 in a Phase 1 melanoma study, 80 in a Phase 2 melanoma study, 10 in an investigator-initiated study of PV-10 chemoablation followed by radiotherapy, and over 140 patients enrolled in the Compassionate Use Program for PV-10. Additionally, 11 of the 80 Phase 2 melanoma study subjects continued with the Compassionate Use Program.

Phase 1 Clinical Trial

  • A Phase 1 study was initiated in February 2016 to Assess the Safety, Tolerability and Effectiveness of PV-10 Chemoablation of Neuroendocrine Tumors (NET) Metastatic to the Liver in the Reduction of Biochemical Markers and Symptoms Caused by Secretory Products

    Primary Outcome Measures:

    • Number of Participants with Adverse Events [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]

      Incidence of Systemic and Locoregional Adverse Events will be Coded and Tabulated.

    Secondary Outcome Measures

    • Objective Response Rate (ORR) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

      Response of Injected Target and Measurable Bystander Lesions (if present) will be Tabulated

    • Target Lesion Somatostatin Receptor (SSTR) Expression [ Time Frame: 6 months ] [ Designated as safety issue: No ]

      Change in SSTR Expression will be Assessed vs Baseline Values

    • Change in Neuroendocrine Tumor Biomarkers [ Time Frame: 6 months ] [ Designated as safety issue: No ]

      Change in Chromogranin A (CgA) and/or 5-Hydroxyindole Acetic Acid (5-HIAA) will be Assessed vs Baseline Values

    • Reduction in Major Symptoms [ Time Frame: 6 months ] [ Designated as safety issue: No ]

      Change in Major Symptoms (Diarrhea and Flushing) will be Separately Assessed using European Organization for Research and Treatment of Cancer QLQ-C30 and GI.NET21 Symptom Scores vs Baseline Values

    • Reduction in Other Symptoms [ Time Frame: 6 months ] [ Designated as safety issue: No ]

      Change in Other Symptoms (including Bronchoconstriction and Abdominal Cramping) will be Separately Assessed using QLQ-C30 and GI.NET21 Symptom Scores vs Baseline Values

    • Change in Peripheral Blood Mononuclear Cells (PBMC) [ Time Frame: 28 days ] [ Designated as safety issue: No ]

      Change in PBMC will be Assessed vs Baseline Values

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