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Moleculin Receives Approval in Italy to Conduct Phase 1/2 Trial Evaluating Annamycin in Combination with Cytarabine (Ara-C) for the Treatment of Acute Myeloid Leukemia (AML)
– Ongoing efforts to open additional clinical sites in Poland and to gain approval to proceed in other European countries – First subject treated in Italy
About this update from Moleculin Biotech, Inc.
[{"type":"text","content":"– Ongoing efforts to open additional clinical sites in Poland and to gain approval to proceed in other European countries \n\n \n \n \n \n \n \n\n \n– First subject treated in Italy expected in the first quarter of 2023\nHOUSTON, Dec. 21, 2022 /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 and viruses, today announced it has received approval from the Agenzia Italiana del Farmaco (AIFA, the Italian Medicines Agency competent authority) and the Istituto Superiore di Sanità (ISS, the Italian National Institute of Health) for its Phase 1/2 trial evaluating Annamycin in combination with Cytarabine (Ara-C) in the treatment of subjects with AML who are refractory to or relapsed after induction therapy (MB-106). This adds to the approval the Company already has in Poland where three sites are currently open and recruiting subjects. Additionally, the Company has ongoing efforts to open additional clinical sites in Poland and Italy and gain approval to proceed in other European countries for the MB-106 clinical trial to potentially improve recruitment rates.\n\"We are pleased to receive authorization to expand our MB-106 trial into Italy. This marks an important milestone in the global expansion of our AML development program. Based on the encouraging data seen to date from the successfully concluded single agent trials, we remain very optimistic in Annamycin's potential to treat refractory or relapsed AML in combination with Cytarabine. We are committed to driving enrollment and our team is working diligently to bring additional sites online and enroll subjects for the study,\" commented Walter Klemp, Chairman and CEO of Moleculin. He continued, \"In Poland we expect the first subject to be treated in MB-106 to be in the near term.\"\nAnnamycin is the Company's next-generation anthracycline that has been designed to be non-cardiotoxic and has been shown in animal models to accumulate in the lungs at up to 30-fold the level of doxorubicin (a commonly prescribed anthracycline), as well as demonstrating the ability to avoid the multidrug resistance mechanisms that typically limit the efficacy of doxorubicin and other currently prescribed anthracyclines. Annamycin is currently in developmen...