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Moleculin Announces Additional Positive Safety Data in EU AML Trial
A Total of 19 Patients Now Have Shown No Signs of Cardiotoxicity HOUSTON, April 2, 2020 /PRNewswire/ -- Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin"
About this update from Moleculin Biotech, Inc.
[{"type":"text","content":"A Total of 19 Patients Now Have Shown No Signs of Cardiotoxicity\n\n\nHOUSTON, April 2, 2020 /PRNewswire/ -- Moleculin Biotech, Inc., (Nasdaq: MBRX) (\"Moleculin\" or the \"Company\"), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors, today announced it has completed the latest (210 mg/m2) cohort in its European open label, single arm Phase 1/2 clinical trial of Annamycin for the treatment of relapsed or refractory acute myeloid leukemia (\"AML\"). A total of 19 patients have been treated in the US and Europe, and all results continue to show Annamycin to be safe, and, especially, all have shown Annamycin to be free of cardiotoxicity. Of those, 10 have been treated at or above the FDA lifetime maximum anthracycline exposure.\n\n \n \n \n \n \n \n\n \nThe Phase 1 portion of this clinical trial, which is described in more detail later in this press release, is designed to establish the safety of Annamycin and to determine the Recommended Phase 2 Dose to be used in the Phase 2 portion of the trial. While the Primary Endpoint of the Phase 1 portion is safety, a Secondary Endpoint is the assessment of efficacy generally defined as an improvement in bone marrow biopsy results sufficient to qualify patients for a potentially curative bone marrow transplant. The Company cautions not to place undue reliance on interim results. \nThe fourth cohort in Poland receiving a single dose of 210 mg/m2 in the Phase 1 dose escalation portion of the trial was completed with no adverse events and the trial will continue to the next cohort of 240 mg/m2. To date in the European trial, only one adverse event related to Annamycin has been reported; a patient experienced grade 2 mucositis (which resolved to grade 1 within 2 days). In the Company's recently completed Phase 1 portion of a parallel US Phase 1/2 clinical trial, there were no unexpected serious adverse events (SAE) and no dose limiting toxicities (DLT) at any dose tested. \nWe refer to Annamycin as a \"next generation anthracycline,\" because it is designed to provide enhanced therapeutic benefits when compared with traditional anthracyclines while reducing the potential for unwanted cardiotoxicity, or damage to the heart. This design intent has previously been validated with preclinical toxicology studies in animal models (as ...