Provectus Pharmaceuticals, Inc., 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.”
Date: April 27, 2011
Source: Provectus Pharmaceuticals, Inc.