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Moleculin Successfully Completes First Cohort in Phase 1b/2 Trial Evaluating Annamycin in Combination with Cytarabine (Ara-C) for the Treatment of Acute Myeloid Leukemia (AML)
Preliminary results demonstrate a durable complete response at starting dose level in elderly subject Positive results from first cohort allows Company to
About this update from Moleculin Biotech, Inc.
[{"type":"text","content":"Preliminary results demonstrate a durable complete response at starting dose level in elderly subject\nPositive results from first cohort allows Company to progress to second cohort in Phase 1b portion of the Phase 1b/2 trial with 230 mg/m2 dose of Annamycin \nHOUSTON, May 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 tumors and viruses, today announced the successful completion of the first cohort in the Phase 1b portion of its Phase 1b/2 clinical trial using Annamycin in combination with Cytarabine for the treatment of AML (MB-106).\n\n \n \n \n \n \n \n\n \nIn this first cohort three subjects were treated, all of whom are believed to be relapsed from multiple prior therapies. Annamycin was dosed at 190 mg/m2, along with Cytarabine at 2.0 g/m2/day for 5 days (total dose of 10 g/m2), consistent with the familiar 7+3 regimen, combining daunorubicin and Cytarabine, typically used as a first-line induction therapy. In the Company's study therapy Annamycin replaces daunorubicin. The Company, at the recommendation of the data safety committee, deemed the first cohort dose as safe and opened the second cohort with the Annamycin dose being increased to 230 mg/m2.\nThe median of prior therapies for these three subjects were 5 (2 to 7). One of the subjects, who was 78 years of age at the time of study initiation with 2 prior multi-year therapies, was preliminarily recorded as a complete response at three weeks, or \"CR\", per the protocol. This was subsequently confirmed to be a durable CR after four weeks. The other two subjects were shown to have disease progression. Subjects have already been identified as potential candidates for the second cohort.\n\"We are pleased with the rapid progress of this trial and to be advancing to the second cohort of escalated dosing. These preliminary results demonstrated by Annamycin in combination with Ara-C, add to our confidence in Annamycin's potential to be an important treatment for refractory or relapsed AML. Since it wasn't until we exceeded 210 mg/m2 in our single agent trials that we saw a consistent response rate (80%), we are glad to see a CR at just 190 mg/m2 and are eager to see how subjects respond at 230 mg/m2, esp...