Provectus Receives Orphan Drug Designation From FDA For Anti-Cancer Agent PV-10 For The Treatment Of Metastatic Melanoma

Main Category: Melanoma / Skin Cancer
Also Included In: Regulatory Affairs / Drug Approvals;  Clinical Trials / Drug Trials
Article Date: 09 Jan 2007 - 0:00 PDT

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Provectus Pharmaceuticals, Inc. (OTC Bulletin Board: PVCT) announced today that its leading anti-cancer agent, PV-10, has received orphan drug designation by the U.S. 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."

About PV-10

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(TM), 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 centers, 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 tumors 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. More details of the study are available at http://www.ClinicalTrials.gov (study PV-10-MM-01).

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.

About the Orphan Drug Act

The Orphan Drug Act (ODA) provides for granting special status to a product to treat a rare disease or condition upon request of a sponsor. The combination of the product and the rare disease or condition must meet certain criteria. This status is referred to as orphan designation. Orphan designation qualifies the sponsor of the product for tax credit and marketing incentives of the ODA. A marketing application for a prescription drug product that has been designated as a drug for a rare disease or condition is not subject to a prescription drug user fee unless the application includes an indication other than the rare disease or condition.

About Provectus Pharmaceuticals, Inc.

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. In addition, Provectus is preparing to begin Phase 2 clinical studies for the Company's topical agent Xantryl(TM), a treatment for psoriasis.

This release and others statements issued or made from time to time by the company or its representatives contain comments that may constitute forward- looking statements. Those include statements regarding the intent, belief or current expectations of the company and members of its management teams, as well as the assumptions on which the statements are based. Prospective investors are cautioned that such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, and that actual results may differ materially from those contemplated by such forward- looking statements.

Provectus Pharmaceuticals, Inc.
http://www.pvct.com

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