KNOXVILLE, Tenn., Jan. 8 /PRNewswire-FirstCall/ -- 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."
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 www.ClinicalTrials.gov (study
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
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.
The Company's offices and laboratory are located at 7327 Oak Ridge
Highway, Suite A, Knoxville, TN 37931; telephone: 865 769 4011. For more
information, contact the Company at email@example.com or visit the corporate
Web site: http://www.pvct.com.
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.
SOURCE Provectus Pharmaceuticals, Inc.