The EMA grants MRG-106 Orphan Drug Designation for Cutaneous T-Cell Lymphoma

On 24th May 2017, the European Medicines Agency (EMA) granted Orphan Drug Designation status to MRG-106 for the treatment of patients with CTCL.

miRagen Therapeutics’ MRG-106 is an inhibitor of miR-155, which is elevated in malignant T-cells. MiR-155 is a key player in a range of normal and malignant cell pathways and processes, and potentially contributes to CTCL cell progression and survival.

A phase I trial (NCT02580552) of MRG-106 in Mycosis Fungoides type CTCL (MF-CTCL) is currently being carried out; results will be presented during this year’s American Society of Clinical Oncology Annual Meeting, taking place in Chicago between 2nd–6th June.

MRG-106 also holds Orphan Drug Designation for Mycosis Fungoides type CTCL from the U.S. Food and Drug Administration (FDA), awarded in March 2017.

  1. Lymphoma News Today. EU Gives Orphan Drug Status to MRG-106 for Treating T-cell Skin Lymphomas. 2017 May 26. https://lymphomanewstoday.com/2017/05/26/eu-grants-orphan-drug-status-to-skin-lymphoma-therapy-mrg-106/. [Accessed 2017 May 30].