Moleculin Announces Plans For MIRACLE Adaptive Phase 3 Clinical Trial Designed For Possible Accelerated Approval Of Annamycin In Combination With Cytarabine For The Treatment Of Relapsed Or Refractory AML
Moleculin Announces Plans For MIRACLE Adaptive Phase 3 Clinical Trial Designed For Possible Accelerated Approval Of Annamycin In Combination With Cytarabine For The Treatment Of Relapsed Or Refractory AML
Based on an encouraging discussion in the End of Phase 1B/2 Meeting with FDA the Company plans to:
经过与FDA的鼓舞人心的第1B/2期会议讨论，该公司计划：
Proceed with a pivotal, adaptive Phase 3 clinical trial (the "MIRACLE" trial) designed for possible accelerated approval of Annamycin in combination with cytarabine for the treatment of relapsed or refractory AML;
进行关键的、自适应的第3期临床试验（“MIRACLE”试验），旨在可能加速批准Annamycin与紫杉醇联合治疗复发或难治性AML；
Run such future studies globally and in the US above the lifetime maximum allowable anthracycline dose; and
在全球范围内和美国之外运行这样的未来研究，并且在超过人生最大允许的蒽环类药物剂量的情况下进行；以及
Provide the FDA with additional data supporting the selection of the optimal dosing level via the adaptive design in the MIRACLE trial
向FDA提供额外数据，支持在MIRACLE试验中通过自适应设计选择最佳剂量水平的选择
HOUSTON, Aug. 1, 2024 /PRNewswire/ -- 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 positive discussion in and outcome of its End of Phase 1B/2 (EOP1B/2) meeting with the US Food and Drug Administration (FDA) supporting the advancement of 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") to a Phase 3 pivotal trial for the treatment of AML patients who are refractory to or relapsed after induction therapy (R/R AML). This Phase 3 "MIRACLE" trial (derived from Moleculin R/R AML AnnAraC Clinical Evaluation) will be a global trial, including sites in the US.
2024年8月1日，休斯顿 / PRNewswire / --分子科技生物公司（NASDAQ:MBRX）（“分子科技”或“公司”），一家具有面向难以治疗的肿瘤和病毒的广泛药物候选组合的临床阶段制药公司，今天宣布，在与美国食品与药物管理局（FDA）的第1B/2期会议上，对Annamycin与紫杉醇（也称为“Ara-C”，Annamycin和Ara-C的组合被称为“AnnAraC”）的推进给予支持，目的是治疗难治性或复发性AML患者（R/R AML）在诱导治疗后难以对抗。该第3期“MIRACLE”试验（派生自分子科技R/R AML AnnAraC临床评估）将是一项全球试验，包括美国的试验点。