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Moleculin Doses First Subjects in Phase 2 Portion of Clinical Trial Evaluating Annamycin in Combination with Cytarabine (Ara-C) for the Treatment of Acute Myeloid Leukemia (AML)
– Phase 1B portion of Phase 1B/2 study demonstrated preliminary CR/CRi rate of 33% (n=6) – Annamycin has Fast Track Status and Orphan Drug Designation from
About this update from Moleculin Biotech, Inc.
[{"type":"text","content":"– Phase 1B portion of Phase 1B/2 study demonstrated preliminary CR/CRi rate of 33% (n=6) \n– Annamycin has Fast Track Status and Orphan Drug Designation from FDA for the treatment of AML\nHOUSTON, Oct. 2, 2023 /PRNewswire/ -- Moleculin Biotech, Inc., (Nasdaq: MBRX) (Moleculin or the Company), a clinical stage pharmaceutical company with a growing pipeline, including Phase 2 clinical programs, for hard-to-treat cancers and viruses, today announced the initial subjects have been treated in the Phase 2 portion of the Company's Phase 1B/2 trial evaluating Annamycin in combination with Cytarabine (Ara-C) for the treatment of subjects with AML (MB-106).\n\n \n \n \n \n \n \n\n \nWalter Klemp, Chairman and Chief Executive Officer of Moleculin commented, \"This milestone marks an important step in advancing the development of Annamycin for the treatment of AML. Based on the positive preliminary results demonstrated in the Phase 1B portion of this trial, we continue to believe that Annamycin has the potential to be a meaningful treatment option for the treatment of AML. Our team is dedicated to building on the momentum and encouraging results to bring this study across the finish line and towards late-stage development.\"\nThe Phase 1B/2 MB-106 trial is an open label trial that builds on the safety and dosage data from the two successfully concluded single agent Annamycin AML Phase 1 trials, MB-104 and MB-105, conducted in the U.S. and Europe, respectively.\nAs previously announced, Moleculin successfully and safely completed the Phase 1B portion of the trial at 230 mg/m2 of Annamycin in this combination study in August 2023. The total complete response (CR) or complete response with incomplete recovery of peripheral blood count (CRi) demonstrated in the Phase 1B portion of this combination trial was two out of six subjects or 33%. The median age of these subjects was 66 years of age. These data are preliminary and subject to change. In light of the safety and encouraging efficacy seen in the Phase 1B portion of this trial and the final (240 mg/m2) cohort of the MB-105 single agent trial, the safety review committee have concluded (and the Company concurs) that the Phase 2 portion will be conducted at the 230 mg/m2 level of Annamycin dosing.\nAnnamycin is the Company's next-generation anthracycline that has been designed to be non-cardio...