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

May 31, 2017

On 24 thMay 2017, the European Medicines Agency ( EMA) granted Orphan Drug Designation status to MRG-106for 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 OncologyAnnual Meeting, taking place in Chicago between 2 nd–6 thJune.

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].