Provectus Pharmaceuticals, Inc. announced that the company's leading anti-cancer agent, PV-10, has received orphan drug designation by the US Food and Drug Administration (FDA) for the treatment of metastatic melanoma. Provectus is currently conducting a clinical study of PV-10 in Australia on subjects with metastatic melanoma.

Orphan drug designation entitles Provectus to exclusive PV-10 marketing rights in the United States for up to seven years should Provectus be the first company to receive marketing approval for this therapeutic drug product. In addition, the designation allows Provectus to apply for a waiver from the FDA of certain user fees required by the Prescription Drug User Fee Act (PDUFA).

"We are encouraged that the FDA has granted PV-10 orphan drug designation, which is the first in a list of regulatory benchmarks we are pursuing," said Provectus CEO Craig Dees, Ph.D. "We are taking an aggressive but deliberate approach in working with the FDA and would like to make PV-10 available for metastatic melanoma patients, many of whom have very few options, as soon as the regulators will allow it. For the moment, this orphan designation puts us first in line and, along with financial and regulatory benefits, will grant us market exclusivity, as long as we keep our trials on schedule and garner FDA approval as planned."

Provectus is nearing completion of its 20-subject Phase 1 study of the safety and efficacy of PV-10, an injectable formulation of Rose Bengal also known as Provecta, for the ablation of metastatic melanoma, an aggressive and often fatal form of skin cancer. Provectus expects to commence a pivotal Phase 2/3 study of the efficacy of PV-10 in the treatment of metastatic melanoma shortly thereafter.

The clinical trial of PV-10 is being conducted at two of the world's leading melanoma treatment and research centres, the Sydney Melanoma Unit and the Newcastle Melanoma Unit, both located in New South Wales, Australia, a country where the incidence of melanoma is more than twice that of the United States. Each subject enrolled in the study has one or more tumours treated with a single injection of PV-10 and the local response to the treatment is then observed for a period of 12 to 24 weeks.

Pre-clinical animal studies have shown broad-spectrum applicability of the agent for selective ablation of a number of cancers, including melanoma, breast carcinoma, and hepatocellular carcinoma.

Provectus Pharmaceuticals, Inc. is an innovative biopharmaceutical company actively engaged in the design, development, and marketing of pharmaceutical technologies for the treatment of breast cancer, liver cancer, and metastatic melanoma.