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April 03, 2016 | Tom Ballard

International expert on melanoma shares views on PV-10 drug

Sanjiv AgarwalaBy Tom Ballard, Chief Alliance Officer, PYA

An internationally-known expert in the research and treatment of melanoma and cutaneous malignancies shared his views of intralesional therapies including his optimism about PV-10, a drug being developed by Knoxville-based Provectus Biopharmaceuticals, Inc., during a series of meetings in Knoxville last week.

The invitation only sessions, hosted by PYA Co-Founder and Chief Executive Officer Ed Pershing, featured Sanjiv Agarwala, MD, Chief of Medical Oncology and Hematology at St. Luke’s Cancer Center in Philadelphia, PA.

“I’m excited about PV-10,” Agarwala said about the drug which is currently undergoing Phase III clinical trials. “I think it has real potential.”

Provectus Biopharmaceuticals is developing advanced therapies designed to target and destroy the deadliest of cancers – melanoma, liver and breast – while minimizing side effects.

Agarwala is board-certified in oncology, hematology, and internal medicine, is a prolific writer about melanoma, and has been a Principal Investigator for multiple clinical trials involving immunotherapy and targeted therapy for melanoma and other malignancies.

Most of the focus of his presentation was centered on melanoma, although he did briefly touch on some encouraging results of research in the use of PV-10 to treat liver cancer.

“PV-10 targets cancer cells, but it spares normal cells” Agarwala explained.

Provectus launched its Phase I trial in 2005 and the Phase II in 2007. It has been conducting expanded access trials since 2009 and launched its Phase III Randomized Trial in 2015.

Agarwala noted that the Phase II trial included 80 people with a median age “on the high side.” As such, the participants were more likely to have other health issues that could have affected the outcomes.

“The results showed it (PV-10) was very safe in older people with other challenges,” he noted. Specifically, the overall responsive rate in the Phase II trial was about 50 percent.

“It’s a good number,” Agarwala said. “It makes you want to move forward which is what we are doing. It works quickly if it works (for a patient). Most had a (positive) response after one or two injections.”

The Phase III trial involves 225 patients.

Agarwala outlined a two-phase clinical development plan. One phase involves employing PV-10 as a single agent for locally-advanced melanoma. The second uses PV-10 in combination with another agent for widely metastic cancers.

Asked during one of the sessions about its likely use, he predicted it would be used mostly in combination with other drugs.

As those in the life science space know, bringing a new drug to market with all of the U.S. Food and Drug Administration approvals is a lengthy process. Add to that the competitors that might be in the space.

Agarwala cited two in the monotherapy area and to more in the combination space.

“We’re (PV-10) ahead of the competition,” he said. “I really want to see this thing work. I’m optimistic, but that’s why you do clinical trials.”

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