<a href="https://laohu8.com/S/MBRX">Moleculin Biotech</a> Secures RAMPA Approval to Expand Phase 3 MIRACLE Clinical Trial into Georgia, Boosting Global Enrollment Efforts
Moleculin Biotech Inc., a late-stage pharmaceutical company specializing in treatments for challenging cancers and viral infections, has received regulatory approval from the Regulation Agency for Medical and Pharmaceutical Activities (RAMPA) in Georgia for its Phase 2B/3 MIRACLE clinical trial. This pivotal trial, which investigates the combination of Annamycin and cytarabine for treating refractory or relapsed acute myeloid leukemia $(AML.AU)$ in adults, is set to expand globally with sites in the US, Europe, and the Middle East. Following recent approval from the European Medicines Agency $(EMA)$, Moleculin plans to enhance its enrollment efforts by adding 16 additional clinical sites in Europe and the US by the end of August, aiming for over 30 sites for Part A of the trial. The company anticipates reporting initial data from Part A in the second half of 2025.
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