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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.
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In your experience, what is the average time to secure a reimbursed CAR T-cell therapy manufacturing slot for patients with DLBCL (from decision to treatment with a CAR T-cell therapy)?