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Based on an encouraging discussion in the End of Phase 1B/2 Meeting with FDA the Company plans to:
Proceed with a pivotal, adaptive Phase 3 clinical trial (the "MIRACLE" trial) designed for possible accelerated approval of Annamycin in combination with cytarabine for the treatment of relapsed or refractory AML;
Run such future studies globally and in the US above the lifetime maximum allowable anthracycline dose; and
Provide the FDA with additional data supporting the selection of the optimal dosing level via the adaptive design in the MIRACLE trial
HOUSTON, Aug. 1, 2024 /PRNewswire/ -- Moleculin Biotech, Inc., (NASDAQ:MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat tumors and viruses, today announced the positive discussion in and outcome of its End of Phase 1B/2 (EOP1B/2) meeting with the US Food and Drug Administration (FDA) supporting the advancement of Annamycin in combination with Cytarabine (also known as "Ara-C" and for which the combination of Annamycin and Ara-C is referred to as "AnnAraC") to a Phase 3 pivotal trial for the treatment of AML patients who are refractory to or relapsed after induction therapy (R/R AML). This Phase 3 "MIRACLE" trial (derived from Moleculin R/R AML AnnAraC Clinical Evaluation) will be a global trial, including sites in the US.
Posted In: MBRX
