May 15, 2013

Moffitt's Phase 1 Feasibility Trial for $PVCT's PV-10 (follow-up)

A blog reader reminder me about the February article "Back to Phase 1: Understanding Systemic Effects of PV-10" in CancerWatch (Vol. 22 Feb. 2013) that discussed the background and motivation for Moffitt's Phase 1 study of the systemic antitumor effects of intralesional PV-10 treatment. It's worth re-reading the article again in the context of Moffitt purportedly completing the bulk of its feasibility study work.

“A further impetus toward teasing out the precise mechanism of how PV-10 can exert a systemic immune response in patients,” said Dr. Sarnaik in an interview, “is to allow us to rationally combine PV-10 treatment with some of the exciting emerging immunotherapies for metastatic melanoma.”

“We are really interested in harnessing immune cell infiltrate as a form of treatment,” he said, noting also that while creating cancer vaccines has been thought of traditionally as one of the Holy Grails of cancer research, cancer vaccines have turned out to be not strong enough to generate an adequate immune response.

Dr. Sarnaik said, only about half the time. “We generate large numbers of T-lymphocytes, but we 
don’t have control over their quality. We think one of the limitations is that the T cells you get out of the tumor just aren't good enough.” PV-10, however, does cause an immune response, suggesting that a combination treatment may improve the quality of the T-lymphocytes and have a greater impact on the disease. When Shari Pilon-Thomas, PhD, also a Moffitt researcher, demonstrated that T-lymphocytes recovered from mice treated with PV-10 do appear to be of a higher quality, as evidenced by stronger 
tumor reactivity, the stage was set for Dr. Sarnaik’s current 15-patient pilot study.

“This is a straightforward study that will give a yes or no answer,” Dr. Sarnaik said.

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