Geron Announces First Patient Dosed in IMerge Phase 3 Clinical Trial in Lower Risk Myelodysplastic Syndromes

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[{"type":"text","content":"MENLO PARK, Calif., Oct. 10, 2019 (GLOBE NEWSWIRE) -- Geron Corporation (Nasdaq: GERN) today announced that the first patient has been dosed in the IMerge Phase 3 clinical trial to evaluate imetelstat, a first-in-class telomerase inhibitor, in lower risk myelodysplastic syndromes (MDS).\n “Patients with lower risk MDS become dependent on serial transfusions which leads to iron overload, heart and kidney complications, decreases in quality of life and shorter overall survival. Reducing transfusion burden and achieving transfusion independence remain significant medical needs for this disease,” said Aleksandra Rizo, M.D., Ph.D., Geron’s Chief Medical Officer. “Dosing of the first patient in the IMerge Phase 3 clinical trial is an important step in developing imetelstat as a potential alternative for patients with lower risk MDS who have limited treatment options available today.” IMerge is a two-part Phase 2/3 clinical trial of imetelstat in transfusion dependent patients with lower risk MDS who are relapsed after or refractory to erythropoiesis-stimulating agents (ESAs). The Phase 3 is planned to enroll approximately 170 patients in a randomized, double-blind, placebo-controlled clinical trial to test the hypothesis that imetelstat improves the rate of red blood cell transfusion independence (TI). A target patient population of non-del(5q) lower risk MDS patients who are naïve to treatment with hypomethylating agents (HMAs) and lenalidomide was identified in Part 1 of IMerge, or the Phase 2 portion, and will be enrolled in the Phase 3. The trial is planned to be conducted at multiple medical centers globally, including North America, Europe, Middle East and Asia. The primary endpoint is 8-week TI rate, which is defined as the proportion of patients achieving transfusion independence during any consecutive eight weeks since entry into the trial. Key secondary endpoints include the rate of transfusion independence lasting at least 24 weeks, or 24-week TI rate, durability of transfusion independence and the amount and relative change in transfusions. Recently reported Phase 2 data from Part 1 of IMerge suggested meaningful and durable transfusion independence, as well as potential disease-modifying activity and transfusion independence across different MDS patient subgroups, potentially achievable with imetelstat treatment. Many key...

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