On 31 stMarch 2017, the U.S. Food and Drug Administration ( FDA) granted Orphan Drug Designation status to MRG-106 for the treatment of Mycosis Fungoides type Cutaneous T-Cell Lymphoma (MF-CTCL).
MicroRNA-155 has been reported at aberrantly high levels in a range of hematological malignancies and has various roles in differentiation and proliferation of blood cells and lymphocytes. miRagen Therapeutics’MRG-106 is a microRNA-155 inhibitor.
Currently, the safety, tolerability, and pharmacokinetics of intravenous MRG-106 is being evaluated in a phase I clinical trial ( NCT02580552) of patients with MF-CTCL. The estimated primary completion date is July 2017.