Benzinga | Oct 18, 2021 07:32AM EDT

Geron Announces Completion Of Patient Enrollment In IMerge Phase 3 Clinical Trial In Lower Risk Myelodysplastic Syndromes

Geron Corporation (NASDAQ:GERN), a late-stage biopharmaceutical company focused on the development and commercialization of treatments for hematologic malignancies, today announced the completion of patient enrollment in the IMerge Phase 3 clinical trial to evaluate imetelstat, a first-in-class telomerase inhibitor, in lower risk myelodysplastic syndromes (MDS). Based upon current planning assumptions, Geron expects top-line results for IMerge Phase 3 to be available at the beginning of January 2023.

"Completing patient enrollment in IMerge Phase 3 brings us one step closer to delivering imetelstat as a potential treatment alternative for patients with lower risk MDS who are relapsed or refractory to ESAs. Achieving durable transfusion independence remains a significant medical need for these patients," said Aleksandra Rizo, M.D., Ph.D., Geron's Chief Medical Officer. "I would like to thank all of the patients and their families, the investigators, clinical site staff, as well as our employees for supporting the achievement of this important milestone."

Patients from the IMerge Phase 2 clinical trial achieved durable transfusion independence with imetelstat treatment, including transfusion-free periods greater than one year, irrespective of the disease subgroup, such as ringed sideroblast positive or ringed sideroblast negative. Such durability provides significant and meaningful clinical benefit to lower risk MDS patients given their chronic anemia and the debilitating impact of serial blood transfusions. In addition, depletion of cytogenetic abnormalities and reductions in key driver mutations associated with lower risk MDS were observed, and these results were also correlated with transfusion independence. Based on the IMerge Phase 2 data, taken together, the durability, molecular and cytogenetic data provide strong evidence for disease-modifying activity of imetelstat, which has the potential to differentiate it from other currently approved and investigational treatments in lower risk MDS today.