Provectus Receives Orphan Drug Designation from FDA for the Treatment of Liver Cancer
Business Wire News Release
Provectus Pharmaceuticals Inc
2011-04-26T16:05:00-04:00
KNOXVILLE, Tenn.--(BUSINESS WIRE)--Apr. 26, 2011-- Provectus Pharmaceuticals, Inc. (OTC BB: PVCT,
pvct.com),  a development-stage oncology and dermatology biopharmaceutical company, has
received orphan drug designation by the U.S. Food and Drug Administration (“FDA”) for Rose Bengal, the
active ingredient in its novel oncology drug PV-10, for the treatment of hepatocellular carcinoma (“HCC”), the
most common form of primary liver cancer. Provectus completed patient accrual and treatment of all
subjects in its Phase 1 clinical trial of PV-10 for liver cancer in January 2011, and is currently designing a
Phase 2 study.
Receiving orphan drug designation entitles Provectus to exclusive marketing rights for PV-10 for HCC in the
United States for up to seven years if it is the first company to receive marketing approval for this therapeutic
drug product. In addition, orphan drug designation allows Provectus to apply for a waiver from the FDA of
certain user fees required by the Prescription Drug User Fee Act (PDUFA).
“Receiving orphan drug designation for hepatocellular carcinoma, in combination with our strategy for
patent protection of PV-10, is another important step in assuring the value of the company’s proprietary
property once regulatory approval is achieved,” said Dr. Craig Dees, PhD, CEO of Provectus. “Based upon
our clinical trials of PV-10 for metastatic melanoma, as well as on the results we are seeing in our
Compassionate Use Program for PV-10 for non-visceral cancers, we believe PV-10 will be a safe and
effective treatment for many different types of cancers. Preliminary analysis of the results of the Phase 1 liver
cancer trial shows that PV-10 should have a role in the treatment of tumors of the liver.”
Dr. Dees added, “Orphan drug designation for liver cancer will provide us market exclusivity, as well as
financial and regulatory benefits, provided that the trials are completed successfully and the treatment
receives FDA approval.” |
