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.
臨床階段藥物公司Moleculin Biotech，Inc.（NASDAQ：MBRX）（“Moleculin”或“公司”）宣佈完成了美國食品和藥物管理局（FDA）舉行的第二階段結束會議（EOP2），旨在評估治療難以治療的腫瘤和病毒的廣泛抗癌藥物候選方案組合使用Annamycin和Cytarabine（也稱爲“ Ara-C ”，而Annamycin和Ara-C的組合稱爲AnnAraC）治療因誘導治療無反應或復發的急性髓性白血病一線療法和二線療法（Mb-106）。公司預計在收到FDA的官方會議記錄後，於2024年第3季度末報告EOP2會議結果。