On June 4, 2014 Provectus Pharmaceuticals reported new findings on PV-10, an investigational intra-lesional therapy for melanoma, were presented during the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper)’s Annual Meeting on May 31, 2015, Chicago, Illinois, USA (Press release, Provectus Pharmaceuticals, JUN 4, 2015, View Source [SID:1234505231]). The presentation entitled "A Changing Topography: The Role of Intralesional Therapy in Melanoma" was presented by Dr. Sanjiv Agarwala, from St. Luke’s Cancer Center in Bethlehem and Temple University School of Medicine in Pennsylvania, USA.
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Melanoma is a cancer that has its origins in melanocytes, cells that produce the brown pigment called melanin which protects the deeper layers of the skin from the harmful effects of the sun. Melanoma is much less frequent than basal cell and squamous cell skin cancers, but it is far more dangerous. Like basal cell and squamous cell cancers, melanoma is almost always curable if detected earlier but has a higher probability to spread to other parts of the body if it is not detected early.
PV-10 is Provectus Biopharmaceuticals’ new experimental drug for cancer, and was designed to be injected into solid tumors i.e. intralesional administration, to reduce potential systemic adverse effects. The FDA has already granted an orphan drug designation for Provectus’ melanoma and hepatocellular carcinoma indications.
Dr. Sanjiv Agarwala established as mains goals of intra-lesional therapy local disease control (decreasing tumor size during a prolonged period), control of symptoms and palliation, decreased systemic effect (immune mediated), delay or prevention of systemic treatment and neo-adjuvant potential. The researcher showed results from the phase 3 trial from T-VEC, an HSV-1-derived oncolytic immunotherapy conceived to induce local and systemic effects. He also showed phase 2 findings for PV-10, showing the drug accumulated within cancer cells but not normal cells, inducing acute autophagy and exposing antigenic tumor fragments to antigenic presenting cells (APCs).
Dr. Agarwala stated that intralesional approaches may hold a promising value, since they act locally and do not have a systemic immune effect. Moreover the researcher concluded that combination therapies are probably the future of melanoma treatment and may be the best way to transition into clinical practice.