During the 29th annual meeting of the Society for Immunotherapy of Cancer, Dr. Shari Pilon-Thomas of the Moffitt Cancer Center, presented a study titled “Efficacy of Intralesional Injection with PV-10 in Combination with Co-Inhibitory Blockade in a Murine Model of Melanoma”, revealing new results that encourage the combination of PV-10 and co-inhibitory blockade drugs for the treatment of melanoma.
In recent years, the medical community has focused on the effects of PV-10, a 10% solution of Rose Bengal developed by Provectus Pharmaceuticals, for the treatment of melanoma. Originally a wool dye, Rose Bengal was also used as a stain to distinguish between healthy and necrotic tissue in the cornea.
PV-10 has been developed for injection into solid tumors such as melanoma, breast and liver cancers, reducing the potential for systemic side effects, and has received orphan drug designations from the U.S. Food and Drug Administration (FDA) for its melanoma and hepatocellular carcinoma indications.
In previous Phase 2 clinical trials of the drug, results demonstrated that 50% of patients suffering from locally advanced cutaneous melanoma, who had all their lesions injected with the investigational agent PV-10, achieved a complete response. Due to the promising results, Provectus has already submitted a protocol to the FDA for the initiation of a Phase 3 study.
The new data presented by Dr. Pilon-Thomas suggests that there are alternative ways to use PV-10 as an anti-cancer drug, such as using it in combination with immune checkpoint blockade.
The research team treated mice models of melanoma either with PV-10 alone or in combination with one checkpoint inhibitor (either anti-CTLA4, anti-PD-1 or anti-PD-L1). The results demonstrated using PV-10 in combination with either one of the inhibitory drugs was more efficient and increased anti-tumor immune responses.
“This important work further validates use of an intralesional therapy with a systemic immunotherapy, and solidifies our plans for a promising second path for development of PV-10. In addition to use as a single-agent therapy for cutaneous melanoma (the focus of our phase 3 study), these findings support commencement of clinical testing of PV-10 in combination anti-CLTA-4, anti-PD-1 or anti-PD-L1 agents. We are assessing strategies to allow this work to commence in a timely and cost-effective manner so that we can begin translating these model test results into human clinical data”, said Eric Wachter, PhD and Chief Technology Officer of Provectus, in a press release.