The United States Food and Drug Administration (FDA) has granted Orphan Drug Designations (ODD) to United States-based Viracta Therapeutics, Incorporated's Phase two drug candidate, nanatinostat, in combination with the antiviral valganciclovir intended for the treatment of post-transplant lymphoproliferative disorder (PTLD), plasmablastic lymphoma, and angioimmunoblastic T cell lymphoma, it was reported yesterday.

The therapeutic approach is being investigated in a Phase 1b/2 clinical trial of Epstein Barr Virus (EBV) -associated lymphomas, including the Orphan Drug Designations granted subtypes.

The product is an oral histone deacetylase inhibitor that is being investigated in a range of clinical indications. The company says that Viracta's unique treatment approach holds potential to become the first targeted, orally administered epigenetic therapy for EBV-associated cancers.

Drugs that receive ODD from the FDA, such as nanatinostat, obtain seven years of marketing exclusivity, tax credits for clinical trial costs, marketing application filing fee waivers and assistance from the FDA in the drug development process.