Geron (NASDAQ:GERN) has announced it has started patient screening and enrollment of its Phase 3 clinical trials to evaluate its imetelstat drug in lower risk myelodysplastic syndromes (MDS). As quoted in the press release: “The start of the Phase 3 portion of IMerge is a significant milestone for Geron and imetelstat,” said John A. Scarlett, …

Geron (NASDAQ:GERN) has announced it has started patient screening and enrollment of its Phase 3 clinical trials to evaluate its imetelstat drug in lower risk myelodysplastic syndromes (MDS).

As quoted in the press release:

“The start of the Phase 3 portion of IMerge is a significant milestone for Geron and imetelstat,” said John A. Scarlett, M.D., Chairman and Chief Executive Officer. “We are hopeful that the Phase 3 will confirm the encouraging results from the Phase 2 portion, and that imetelstat could become a much-needed treatment alternative for patients with lower risk MDS.”
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 erythroid stimulating agents (ESAs). The Phase 3 portion 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). The trial is planned to be conducted at multiple medical centers globally, including North America, Europe, Middle East and Asia. The primary efficacy 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.
Many key aspects from the Phase 2 portion of IMerge remain the same for the Phase 3 portion. 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 from the Phase 2 portion, and will be enrolled in the Phase 3. In addition, the primary and secondary endpoints, the dose and schedule of imetelstat administration and many of the clinical sites remain the same as in the Phase 2. Recently reported Phase 2 data highlighted the meaningful and durable transfusion independence, disease-modifying activity, and efficacy responses across MDS patient subgroups potentially achievable with imetelstat treatment.