PROVECTUS' CANCER DRUG RECEIVES ORPHAN DRUG DESIGNATION

Provectus Pharmaceuticals' leading anti-cancer agent, PV-10, has been granted orphan drug designation by the FDA for the treatment of metastatic melanoma. Provectus is currently conducting a Phase I clinical study of PV-10 in Australia in 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 drug. 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.

"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 CEO Craig Dees said.

Provectus is nearing completion of its 20-subject Phase I 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. Provectus expects to begin a Phase II/III study of the efficacy of PV-10 in the treatment of metastatic melanoma shortly after.