Provectus Pharmaceuticals, Inc. announced yesterday that they have received orphan drug designation by the U.S. Food and Drug Administration (FDA) for Rose Bengal, the active ingredient in the Company’s novel oncology drug PV-10, for the treatment of hepatocellular carcinoma (HCC). HCC is the most common form of primary liver cancer.
Provectus completed patient accrual and treatment of all subjects in their Phase 1 clinical trial of PV-10 for liver cancer in January 2011. Currently the Company is designing a Phase 2 study.
PV-10 is a proprietary, injectable formulation of Rose Bengal, a compound that has been in use for more than thirty years by ophthalmologists to assess damage to the eye. It has also been used as an intravenous diagnostic to detect ailments of the liver. Rose Bengal has an established safety history, a short half-life in the bloodstream, and is excreted through the liver and kidneys. Provectus Pharmaceuticals has discovered a novel use for Rose Bengal based on the observation that it is selectively toxic to cancer calls through a process called chemoablation. This is where cells undergo a form of cell death that mimics both features of necrosis and apoptosis.
The Company has completed their Phase 2 clinical trial of PV-10 for metastatic melanoma. They are currently in conversation with both the Food and Drug Administration (FDA) regarding the design of a pivotal Phase 3 randomized controlled trial suitable for SPA (Special Protocol Assessment), and the Australian Therapeutic Goods Administration to review regulatory approval of PV-10 for melanoma in Australia.
Dr. Craig Dees, PhD, CEO of Provectus Pharmaceuticals, Inc. said, “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. 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 further 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.”
Receiving orphan drug designation entitles Provectus Pharmaceuticals, Inc. 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. Moreover, orphan drug designation allows the Company to apply for a waiver from the FDA of certain user fees required by the Prescription Drug User Fee Act (PDUFA).
Headquartered in Knoxville, Tennessee, Provectus Pharmaceuticals, Inc. specializes in developing oncology and dermatology therapies. Their oncology focus is on melanoma, breast cancer, and metastatic cancers of the liver. Their dermatological drug PH-10 also targets abnormal or diseased cells, with the current focus on psoriasis and atopic dermatitis.
For more information, visit www.pvct.com