<a href="https://laohu8.com/S/MBRX">Moleculin Biotech</a> Initiates Phase 3 MIRACLE Trial for Acute Myeloid Leukemia with First EU Patient Dosed
Moleculin Biotech Inc., a late-stage pharmaceutical company, has announced the dosing of its first European Union patient in the Phase 3 pivotal MIRACLE trial, which aims to evaluate the efficacy of Annamycin in combination with cytarabine for the treatment of adult patients with acute myeloid leukemia (AML) who are refractory to or have relapsed after induction therapy. The trial is designed as a multi-center, randomized, double-blind, placebo-controlled study and is part of a global approval initiative. Active recruitment is ongoing in the US, Spain, Ukraine, Georgia, and Romania, with further sites expected to open soon. Moleculin aims to recruit 45 subjects by the fourth quarter of 2025 for initial data unblinding. Results from appropriate nonclinical GLP studies in the EU will be required before moving to the Phase 3 portion of the study. Approximately 220 additional subjects will be randomized in Part B of the trial. The results of the trial have not yet been presented.
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