June 23, 2014

"Intralesional Rose Bengal in patients receiving injection of all existing melanoma"

In the video below, Dr. Agarwala discusses PV-10, and Provectus and Moffitt's ASCO 2014 posters.

I think Dr. Agarwala raises a key point. Many Phase 2 patients in Provectus' PV-10 trial were elderly, and received multiple prior therapies and treatment for melanoma that did not work (a "fairly refractory group of patients"). See below; the median number of prior treatments was 6.
Click to enlarge
Despite treating patients who appear to have run out of answers and solutions to treat their melanoma before finally receiving PV-10, and presumably having weakened or compromised immune systems, PV-10 nevertheless generated an objective response rate ("ORR") of 51% and achieved a complete response ("CR") of 26% in injected lesions, as well as a 54% ORR in non-injected lesions and a 23% CR in them. Or, about half of the patients in the trial had their tumors shrink (had a response), and a quarter of patients had their tumors shrink completely (go away). Additionally, more than half of the patients had non-injected tumors shrink (had a response), and about a quarter had their non-injected tumors shrink completely (go away).

"Of the 13 consented patients [in Moffitt's feasibility study], 5 had no previous treatment, 6 received ILI or ipilimumab [sold as Yervoy], and 2 received PD-1 blocking antibody; 6 received two or more prior systemic therapy." ILI refers to isolated limb infusion. Other systemic therapies included vemurafenib (sold as Zelboraf), temozolomide or "TMZ" (an orally administered systemic chemotherapy), and carbotaxol (another systemic chemotherapy).

It would seem Provectus' pivotal Phase 3 trial may prove PV-10 has the potential to be better (much better) than what's available today and on the horizon for patients, both in terms of "new melanoma drugs" (e.g., anti-CTLA-4, BRAF and anti-PD-1 agents) and standards of care (i.e., systemic chemotherapy). In particular, the trial would take patients that have progressed on systemic immunotherapies (i.e., anti-CTLA-4 and anti-PD-1 agents), have not responded to them, or cannot receive them.

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