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Moleculin Receives First Country Approval in Europe to Begin Recruiting for the MIRACLE Phase 3 R/R Acute Myeloid Leukemia (AML) Pivotal Trial
First of many site approvals, including sites in the US, Europe and the Middle East, expected throughout Q1-Q3 2025 Company remains on track for first subject
About this update from Moleculin Biotech, Inc.
[{"type":"text","content":"First of many site approvals, including sites in the US, Europe and the Middle East, expected throughout Q1-Q3 2025 \nCompany remains on track for first subject treated in pivotal, adaptive Phase 3 clinical trial (the \"MIRACLE\" trial) in the first quarter of 2025\nRecently amended protocol accelerates unblinding of preliminary primary efficacy data (CR) and safety/tolerability of the three arms at first 45 subjects, expected in the second half of 2025\nHOUSTON, Feb. 11, 2025 /PRNewswire/ -- Moleculin Biotech, Inc., (Nasdaq: MBRX) (\"Moleculin\" or the \"Company\"), a late-stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat tumors and viruses, today announced it has received first country regulatory approval in Europe to begin recruiting for its Phase 3 pivotal trial protocol evaluating 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\") for the treatment of AML patients who are refractory to or relapsed after induction therapy (R/R AML) (MB-108). In Ukraine the final necessary regulatory approvals from the Ministry of Health were received last week. This Phase 3 \"MIRACLE\" trial (derived from Moleculin R/R AML AnnAraC Clinical Evaluation) will be a global trial, including sites in the US, Europe and the Middle East.\n\n \n \n \n \n \n \n\n \n\"We continue to make solid progress across our site initiation and enrollment efforts. Achieving this important milestone of receiving our first country's approval puts us another step closer to getting this study well underway and further bolsters our confidence that we're on track for unblinded preliminary data from the first 45 subjects in the second half of this year. Our team remains committed to operational execution and face-to-face meetings with investigators, over 30 investigators in 11 countries of which I personally have met,\" commented Walter Klemp, Chairman and Chief Executive Officer of Moleculin. \"Building on this momentum, we are focused on getting more of the initial 25 sites we have selected to date on board and enrolling for the study.\"\nThe MIRACLE study, subject to appropriate future filings with and potential additional feedback from the FDA and their foreign equivalents, utilizes an adaptive design whereby the first 75 to 9...