Date: 2016-03-02
Type of information: Initiation of the trial
phase: 1
Announcement: initiation of the trial
Company: Miragen Therapeutics (USA - CO)
Product: MRG-106
Action mechanism: microRNA antagonist. MRG-106 is an inhibitor of microRNA-155 (miR-155) that is found at high levels in the malignant T-cells of many mycosis fungoides patients. miR-155 may be important in promoting the growth and survival of these cancer cells. In laboratory tests, MRG-106 enters lymphoma cells and induces programmed cell death through inhibition of miR-155.
Disease: cutaneous T-cell lymphoma (CTCL), mycosis fungoides subtype
Therapeutic area: Cancer - Oncology - Rare diseases
Country: USA
Trial details: The primary objective of this study is to evaluate the safety and tolerability of the investigational drug, MRG-106, in patients with cutaneous T-cell lymphoma (CTCL), mycosis fungoides subtype. In Part A of the study, MRG-106 will be tested by injection directly into CTCL lesions in the skin. In Part B of the study, MRG-106 will be given by subcutaneous injection or by intravenous infusion. Other objectives of the study are to measure the absorption and clearance of MRG-106 from the blood, and to understand how cells in CTCL skin lesions respond when exposed to MRG-106. (NCT02580552)
Latest news: • On March 2, 2016, miRagen Therapeutics announced that it has initiated a Phase 1 clinical study of MRG-106, a synthetic microRNA antagonist (LNA antimiR®) of microRNA-155. The Phase 1 trial is being conducted in patients suffering from cutaneous T-cell lymphoma (CTCL) of the mycosis fungoides (MF) sub-type. This trial will also explore the molecular signature of MRG-106 in the lesions of MF patients.
