2014

Provectus Receives Orphan Drug Designation from FDA for Anti-Cancer Agent PV-10 for the Treatment Of Metastatic Melanoma Provides Regulatory, Financial and Marketing Benefits



    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."
     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 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.
     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 info@pvct.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.

Custom Packages

Browse our custom packages or build your own to meet your unique communications needs.

Start today.

 

PR Newswire Membership

Fill out a PR Newswire membership form or contact us at (888) 776-0942.

Learn about PR Newswire services

Request more information about PR Newswire products and services or call us at (888) 776-0942.