PV-10 For Recurrent Breast Cancer
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.
- Based on positive safety and tolerability results of the Phase 1 study, as well as histologic evidence of tumor ablation or shrinkage in several subjects, Provectus is well positioned for a Phase 2 study of PV-10 for recurrent breast cancer.
- 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