Moleculin Biotech Completes End Of Phase 2 Meeting With FDA For Annamycin In AML As Both First Line Therapy And For Subjects Who Are Refractory To Or Relapsed After Induction Therapy
Moleculin Biotech Completes End Of Phase 2 Meeting With FDA For Annamycin In AML As Both First Line Therapy And For Subjects Who Are Refractory To Or Relapsed After Induction Therapy
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 tumors and viruses, today announced the completion of its End of Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA) for its Phase 1B/2 clinical trial 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 subjects with AML as both first line therapy and for subjects who are refractory to or relapsed after induction therapy (MB-106). The Company expects to report outcomes from the EOP2 meeting upon receipt of official minutes from FDA which is expected by the end of Q3 2024.
临床阶段药物公司Moleculin Biotech，Inc.（NASDAQ：MBRX）（“Moleculin”或“公司”）宣布完成了美国食品和药物管理局（FDA）举行的第二阶段结束会议（EOP2），旨在评估治疗难以治疗的肿瘤和病毒的广泛抗癌药物候选方案组合使用Annamycin和Cytarabine（也称为“ Ara-C ”，而Annamycin和Ara-C的组合称为AnnAraC）治疗因诱导治疗无反应或复发的急性髓性白血病一线疗法和二线疗法（Mb-106）。公司预计在收到FDA的官方会议记录后，于2024年第3季度末报告EOP2会议结果。