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Trial Testing Rose Bengal Compound as Melanoma Treatment

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A new clinical trial at Moffitt Cancer Center in Tampa, Florida is testing a compound derived from rose bengal, a dye for diagnosing eye disorders, as an injectable treatment for melanoma, a form of skin cancer. The early-stage trial is conducted with Provectus Pharmaceuticals in Knoxville, Tennessee that is commercializing the compound, known as PV-10.

Melanoma is a serious form of skin cancer that develops in the melanocytes, the cells that give skin its color, but can also form in the eyes. Exposure to ultraviolet radiation from sunlight or tanning lamps is believed to increase the risk of melanoma. According to National Cancer Institute, more than 76,000 new cases were diagnosed in the U.S. so far this year, resulting in nearly 9,500 deaths.

PV-10 is a 10 percent solution of rose bengal, a sodium salt used in eye drops to stain damaged cells in the eye, but formulated for injection into melanoma tumors. Provectus is testing PV-10 in early and intermediate-stage clinical trials as a therapy for breast and liver cancer, as well as melanoma.

In a study published in PLoS One last month (funded by Provectus), a Moffitt team led by researcher Shari Pilon-Thomas injected a single dose of PV-10 in mice with melanoma. The results showed significant reductions in cancerous lesions on the skin of the injected mice, as well as reductions in the melanoma tumors that spread to the lungs. In addition, the mice receiving the PV-10 developed a strong immune response against their tumors.

The new study, led by Moffitt’s Amod Sarnaik, is an early-stage trial that aims to find out more how PV-10 works on melanoma tumors, particularly in inducing changes in the body’s immune cells both inside the tumors and circulating in the blood stream. Some 15 patients will receive injections of PV-10.

After 7 to 14 days, biopsies will be taken of the treated and untreated lesions and compared for infiltration of immune cells. Patients will also be tested for circulating immune cells and anti-tumor immunoglobulin G, as well as adverse events associated with the trial. The trial is scheduled to be completed in March 2014.

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