Provectus ocular melanoma treatment gets orphan drug designation
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The FDA has granted an orphan drug designation to PV-10, Provectus BioPharmaceuticals’ ocular melanoma treatment candidate, according to a press release.
Rose bengal disodium, also called PV-10, is a small molecule oncolytic immunotherapy delivered via intratumoral injection, which can yield immunogenic cell death in solid tumor cancers and stimulate tumor-specific reactivity in circulating T cells.
Preliminary data from a phase 1 basket study of PV-10 in four patients with metastatic cancer to the liver yielded tumor reduction in five of six injected tumors. The data were presented at the 15th International Congress of the Society for Melanoma Research in Manchester, England.
Further clinical studies are ongoing.
Reference: Patel SP, et al. Percutaneous oncolytic rose bengal disodium for metastatic uveal melanoma patients with hepatic metastases. Presented at: 15th International Congress of the Society for Melanoma Research; Oct. 24-27, 2018; Manchester, England.