Provectus Biopharmaceuticals, Pfizer Receive Patent Allowance for Use of PV-10 in Combination with Systemic Immunotherapy Agents in Treatment of Cancer

April 19, 2015

Provectus Biopharmaceuticals, Inc., a clinical-stage oncology and dermatology biopharmaceutical company, announced today that it has received from the US Patent and Trademark Office a Notice of Allowance for a joint patent application made with Pfizer, Inc. The patent will protect use of PV-10 in combination with certain other types of drugs in the treatment of melanoma and cancers of the liver.

The allowed claims cover use of PV-10 in combination with systemic inhibitors of immune system down-regulation, such as anti-CTLA-4, PD-1 and PD-L1 antibodies, along with enhancers of immune system up-regulation, such as IL-2 and interferon-gamma. Pre-clinical testing of PV-10 used in combination with these important classes of drugs demonstrated potential importance for treatment of advanced cancers.

The Company hopes that the patent protection afforded by the Notice of Allowance will enable Provectus to realize financial rewards if clinical research demonstrates that PV-10 used in combination with one or more of these other drugs improves patient outcomes.

Data on the invention has been presented at several international meetings since 2013:

At the Society for Immunotherapy of Cancer’s (SITC) 29th Annual Meeting in November 2014, Dr. Shari Pilon-Thomas of the Moffitt Cancer Center presented a poster, entitled “Intralesional Injection with PV-10 in Combination with Co-Inhibitory Blockade in a Murine Model of Melanoma.” She concluded that the new data "support combination therapy with IL PV-10 and co-inhibitory blockade."

At the American Association for Cancer Research (AACR) Annual Meeting in April 2013, Dr. Eric Wachter, Ph.D., Chief Technology Officer of Provectus, presented a poster entitled, "Combination of PV-10 Immuno-chemoablation and Systemic Anti-CTLA-4 Antibody Therapy in Murine Models of Melanoma." At the time, Wachter commented, “This work shows that, as hypothesized, addition of the immunologic effects of an anti-CTLA-4 agent augments the benefits of PV-10. For visceral or other inaccessible disease, combination of PV-10 with CTLA-4 blockade offers important potential for synergy.”

Dr. Wachter noted, “The forthcoming patent arose from discussions several years ago with Dr. Craig Eagle of Pfizer, and appropriately given his contribution he is named as the lead inventor for these claims. In addition to the claimed combinations of PV-10 with immunotherapy agents, the specification covers combination with other classes of agents, and Provectus will pursue these areas through one or more divisional application.”


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