The US Food and Drug Administration (FDA) has granted orphan drug status for Provectus Pharmaceuticals' cancer drug PV-10 as a treatment for liver cancer.
Provectus Pharmaceuticals has already concluded patient recruitment and treatment of all subjects in its PV-10 Phase 1 clinical trial for liver cancer in January 2011.
Preliminary analysis of the results of the Phase 1 liver cancer trial showed that PV-10 should have a role in the treatment of tumors of the liver.
Currently, Provectus is designing a Phase 2 study for the oncology drug.
Provectus CEO Craig Dees said based upon the clinical trials of PV-10 for metastatic melanoma, as well as on the results they are seeing in their Compassionate Use Program for PV-10 for non-visceral cancers, they believe PV-10 will be a safe and effective treatment for many different types of cancers.
"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," Dees said.