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.
Phase 1 Clinical Trial
Primary Outcome Measures:
Incidence of Systemic and Locoregional Adverse Events will be Coded and Tabulated.
Secondary Outcome Measures
Response of Injected Target and Measurable Bystander Lesions (if present) will be Tabulated
Change in SSTR Expression will be Assessed vs Baseline Values
Change in Chromogranin A (CgA) and/or 5-Hydroxyindole Acetic Acid (5-HIAA) will be Assessed vs Baseline Values
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
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 PBMC will be Assessed vs Baseline Values