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Moleculin Announces Final Topline Data from Successful European Phase 1 Trial Evaluating Annamycin as Single Agent Treatment of Relapsed or Refractory Acute Myeloid Leukemia (AML)
– Results align with the overall safety profile of Annamycin – Final cohort demonstrated an 80% overall response rate (ORR) in elderly subjects (≥60 years
About this update from Moleculin Biotech, Inc.
[{"type":"text","content":"– Results align with the overall safety profile of Annamycin\n– Final cohort demonstrated an 80% overall response rate (ORR) in elderly subjects (≥60 years old) \n– No cardiotoxicity demonstrated in any study subject\n– The median number of prior therapies for all subjects was 4 \nHOUSTON, Feb. 13, 2023 /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 cancers and viruses, today announced the following topline results from its MB-105 European Phase 1 clinical trial assessing the safety and efficacy of Annamycin as a single agent for the treatment of adults with relapsed or refractory acute myeloid leukemia (AML). The final MB-105 results align with the overall safety profile of Annamycin and observations made in previously completed and ongoing clinical studies evaluating Annamycin. Additionally in the last cohort where all subjects were at least 60 years of age, Annamycin demonstrated an overall response rate (ORR) of 80%.\n\n \n \n \n \n \n \n\n \n\"We are very pleased with these topline results, both in terms of safety and the initial data suggesting efficacy,\" said Moleculin Chairman and CEO Walter Klemp, \"especially since these patients were relapsed or refractory.\" Mr. Klemp continued, \"Given the recently published research showing that Annamycin in combination with Cytarabine substantially outperformed Annamycin as a single agent in an aggressive AML mouse model, these topline results are encouraging as we continue to develop Annamycin in combination with Cytarabine for the treatment of AML. Having previously announced the start of our open label MB-106 trial of Annamycin in combination with Cytarabine for the treatment of AML Phase 1/2 trial in Poland and Italy, we are optimistic about Annamycin's potential for the treatment of AML, as we continue to gather the data that ultimately will be necessary to support approval.\"\n\"We also are encouraged by the absence of cardiotoxicity with Annamycin to date,\" Mr. Klemp added. \"This is particularly relevant in light of a recently published retrospective study showing that the incidence of heart failure more than doubles for cancer patients treated with anthracyclines compared to cancer patients not receiving anthracyclines.1 Annamyci...