WASHINGTON (dpa-AFX) - Biopharmaceutical company Geron Corp. (GERN) announced Tuesday that the first patient has been dosed in IMpactMF, the Phase 3 clinical trial evaluating imetelstat, a first-in-class telomerase inhibitor, in refractory myelofibrosis (MF).
IMpactMF is an open label, randomized, controlled Phase 3 clinical trial with registrational intent. The trial is designed to enroll approximately 320 patients with Intermediate-2 or High-risk myelofibrosis who are refractory to prior treatment with a JAK inhibitor, also referred to as refractory MF.
Patients will be randomized to receive either imetelstat or best available therapy. The primary endpoint is overall survival (OS). Key secondary endpoints include symptom response, spleen response, progression free survival, complete response, partial response, clinical improvement, duration of response, safety, pharmacokinetics, and patient reported outcomes.
The final analysis for OS is planned to be conducted after more than 50% of the patients planned to be enrolled in the trial have died (referred to as an event). An interim analysis of OS is planned to be conducted after approximately 70% of the total projected number of events for the final analysis have occurred. Under current planning assumptions, the Company expects the interim analysis for IMpactMF to occur in 2024 and the final analysis
IMpactMF is currently enrolling patients. The Company plans to engage over 180 sites to participate in IMpactMF across North America, South America, Europe, Australia and Asia.
Imetelstat is a novel, first-in-class telomerase inhibitor exclusively owned by Geron and being developed in hematologic myeloid malignancies.
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