Geron Announces Fifty Percent Enrollment Milestone in IMerge Phase 3 Clinical Trial in Lower Risk MDS

Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, today announced achievement of fifty percent enrollment in the IMerge Phase 3 clinical trial of imetelstat in lower risk myelodysplastic syndromes (MDS). Data from the IMerge Phase 2 were recently presented at the American Society of Hematology Annual Meeting and support the ongoing Phase 3.

“Reaching fifty percent enrollment is a key milestone towards the completion of this registration-enabling Phase 3 clinical trial, and we appreciate all of the support from our investigators and the patients who are participating in this study,” said Aleksandra Rizo, M.D., Ph.D., Geron’s Chief Medical Officer. “We believe that the IMerge Phase 3 will confirm the meaningful and durable transfusion independence and the disease-modifying activity of imetelstat observed from the Phase 2, and that imetelstat could become a much-needed treatment alternative for patients with lower risk MDS.”

The IMerge Phase 3 is a double-blind, randomized, placebo-controlled clinical trial with registration intent. The trial is designed to enroll approximately 170 transfusion dependent patients with Low or Intermediate-1 risk MDS, or lower risk MDS, who have relapsed after or are refractory to prior treatment with an erythropoiesis stimulating agent (ESA). The primary endpoint is the rate of red blood cell (RBC) transfusion independence (TI) for a consecutive period of eight weeks or longer, or 8-week RBC-TI rate. Key secondary endpoints include the rate of RBC-TI of at least 24 weeks, or 24-week RBC-TI rate, rate of hematologic improvement-erythroid (HI-E), defined as a reduction of at least four units of RBC transfusions over eight weeks compared with the prior RBC transfusion burden, and duration of transfusion independence.

The Company continues to expect full enrollment in the IMerge Phase 3 in the second quarter of 2021. As long as enrollment is completed by the end of the first half of 2021, Geron maintains its projection of top-line results from IMerge to be available in the second half of 2022.

To learn more about IMerge and whether the study is enrolling patients in your area, please visit www.clinicaltrials.gov.

About Myelodysplastic Syndromes (MDS)

Myelodysplastic syndromes is a group of blood disorders in which the proliferation of malignant progenitor cells produces multiple malignant cell clones in the bone marrow resulting in disordered and ineffective blood production. There are approximately 60,000 people in the United States living with the disease and approximately 16,000 reported new cases of MDS in the United States every year. The majority of patients, approximately 70%, fall into the lower risk groups at diagnosis, according to the International Prognostic Scoring System that takes into account the presence of a number of disease factors, such as cytopenias and cytogenetics, to assign relative risk of progression to acute myeloid leukemia (AML) and overall survival.