FDA grants orphan drug status to Provectus Pharma liver cancer drug

In Uncategorized by Caroline Hornby

provectus liver cancer orphan drug 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 Phase 1 clinical trials, and preliminary analysis of the results show 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 drug.

Provectus CEO Craig Dees said that 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.

Read full press release here.

To learn more about orphan drug designation, how to get your drug to market and more, check out the World Orphan Drug Congress USA.