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Geron Announces Plans for Imetelstat Phase 3 Clinical Trial in Myelofibrosis and Other Updates
Geron plans to move forward with a Phase 3 clinical trial in refractory myelofibrosis (MF) with overall survival (OS) as a primary endpoint, which is expected
About this update from Geron Corporation
[{"type":"text","content":"Geron plans to move forward with a Phase 3 clinical trial in refractory myelofibrosis (MF) with overall survival (OS) as a primary endpoint, which is expected to open for screening and enrollment in first quarter 2021Completion of patient enrollment for the ongoing IMerge Phase 3 clinical trial in lower risk myelodysplastic syndromes (MDS) is expected first quarter 2021Revised operating expense guidance of $70 - $75 million for 2020Conference call scheduled for Thursday, May 28 at 4:30 p.m. ET MENLO PARK, Calif., May 21, 2020 (GLOBE NEWSWIRE) -- Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, today announced plans for a Phase 3 clinical trial in MF patients who are refractory to treatment with a janus kinase (JAK) inhibitor, including trial design and expected timelines for trial start and future data readouts. Geron also provided an update on its ongoing IMerge Phase 3 clinical trial in lower risk MDS and reported revised fiscal year 2020 operating expense guidance.\n “We are very pleased to announce that following a productive meeting with the FDA, we plan to move forward with a randomized Phase 3 clinical trial in refractory MF,” said John A. Scarlett, M.D., Chairman and Chief Executive Officer. “Our planned Phase 3 clinical trial in refractory MF will compare imetelstat to best available therapy that excludes JAK inhibitors and has overall survival as the primary endpoint. Also, we have an ongoing Phase 3 clinical trial in lower risk MDS with transfusion independence as the primary endpoint and durability of transfusion independence as a key secondary endpoint. We believe the results from these two Phase 3 clinical trials will differentiate imetelstat, due to its unique mechanism of action, from currently available therapies and enable Geron to become a leader in the treatment of hematologic myeloid malignancies.” Planned Phase 3 Clinical Trial in Refractory Myelofibrosis (MF) The planned Phase 3 clinical trial in refractory MF is designed to be an open label 2:1 randomized, controlled trial to evaluate imetelstat (9.4 mg/kg administered by intravenous infusion every three weeks) in approximately 320 patients with Intermediate-2 or High-risk MF. Patients eligible for the trial will be required to be refractory to a JAK inhibitor, an inclusion criterion that is planned to be defined as havin...