Miragen Therapeutics announces data from Phase 1 cobomarsen trial
Miragen Therapeutics announced data from its Phase 1 clinical trial evaluating the safety, tolerability and efficacy of cobomarsen, an inhibitor of microRNA-155, in cutaneous T-cell lymphoma, or CTCL, and in adult T-cell leukemia/lymphoma, or ATLL. The company will also discuss initial clinical experience in treating diffuse large B-cell lymphoma, or DLBCL, patients with cobomarsen. The data will be presented at the 11th Annual T-Cell Lymphoma Forum. Updated durability data for the 300mg IV infusion cohort of the Phase 1 cobomarsen clinical trial, which is the dose and route of administration being used in the ongoing SOLAR Phase 2 clinical trial, showed that four of eight patients achieved an objective response with greater than four months of durability. The Phase 2 SOLAR trial will evaluate the safety and efficacy of cobomarsen given by intravenous infusion in an active control comparison trial versus Zolinza in patients with CTCL. ORR4 is the primary endpoint that will be used in the SOLAR trial. Based on discussions with the FDA, Miragen believes the results from the SOLAR trial could allow the company to apply for accelerated approval in the United States. Data from the ongoing Phase 1 clinical trial in ATLL has shown that cobomarsen had a favorable safety and tolerability profile with no serious adverse events attributed to the drug candidate in the clinical trial and no documented opportunistic infections, which are common in patients with the disease. Four patients who demonstrated a partial response after chemotherapy have maintained their responses while on cobomarsen monotherapy. Two of these patients have been stable for more than a year. There is evidence of disease stabilization in five patients on cobomarsen, as shown in both peripheral blood and lymph nodes, without negatively impacting the number of normal immune cells. One of these lymphomatous patients with significant adenopathy prior to enrollment has remained stable on cobomarsen, as measured by CT scans, for six months. This includes an objective improvement in three out of four measurable abnormal nodes since initiating cobomarsen therapy.