On 31st March 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.
- Street Insider. miRagen Therapeutics (MGEN) Receives Orphan-Drug Designation for MRG-106 to Treat Mycosis Fungoides. 2017 Mar 31. https://www.streetinsider.com/. [Accessed 2017 Apr 11].