Geron Reports Two Poster Presentations at American Society of Hematology Annual Meeting
Geron Corporation (Nasdaq: GERN) today announced that two posters related to imetelstat, the Company’s first-in-class telomerase inhibitor, were presented at the 61st American Society of Hematology (ASH) Annual Meeting and Exposition in Orlando, Florida on December 8 and 9. Both posters are available on Geron’s website at www.geron.com/r-d/publications.
Trials in Progress Poster Presentation
Title: IMerge: A Study to Evaluate Imetelstat (GRN163L) in Transfusion-Dependent Subjects with IPSS Low or Intermediate-1 Risk Myelodysplastic Syndromes (MDS) That Is Relapsed/Refractory to Erythropoiesis-Stimulating Agent (ESA) Treatment (Abstract #4248)
The poster described key aspects of the IMerge Phase 2/3 clinical trial, including: the trial design; patient eligibility criteria; primary, secondary and exploratory endpoints; and the status of the trial. The poster also included a summary of previously presented data from the Phase 2 portion of the IMerge trial.
IMerge is an ongoing global two-part Phase 2/3 clinical trial of imetelstat in red blood cell (RBC) transfusion dependent patients with Low or Intermediate-1 risk, or lower risk myelodysplastic syndromes (MDS), who have relapsed after or are refractory to prior treatment with an erythropoiesis stimulating agent (ESA). The primary endpoint for the IMerge Phase 2/3 clinical trial is 8-week RBC transfusion independence (TI), 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.
IMerge Phase 3 Trial Now Enrolling
The IMerge Phase 3 is planned to enroll approximately 170 patients in a randomized, double-blind, placebo-controlled clinical trial. The trial will enroll non-del(5q) lower risk MDS patients who are naïve to treatment with hypomethylating agents (HMAs) and lenalidomide. The primary and secondary endpoints remain the same as the Phase 2 portion of the trial. Approximately 90 sites are planned to participate in 12 countries across North America, Europe, Middle East and Asia. Enrollment opened in August 2019, and the first patient was dosed in October 2019.