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:
經過與FDA的鼓舞人心的第1B/2期會議討論，該公司計劃：
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;
進行關鍵的、自適應的第3期臨床試驗（“MIRACLE”試驗），旨在可能加速批准Annamycin與紫杉醇聯合治療復發或難治性AML；
Run such future studies globally and in the US above the lifetime maximum allowable anthracycline dose; and
在全球範圍內和美國之外運行這樣的未來研究，並且在超過人生最大允許的蒽環類藥物劑量的情況下進行；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提供額外數據，支持在MIRACLE試驗中通過自適應設計選擇最佳劑量水平的選擇
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，休斯頓 / PRNewswire / --分子科技生物公司（NASDAQ:MBRX）（“分子科技”或“公司”），一傢俱有面向難以治療的腫瘤和病毒的廣泛藥物候選組合的臨床階段製藥公司，今天宣佈，在與美國食品與藥物管理局（FDA）的第1B/2期會議上，對Annamycin與紫杉醇（也稱爲“Ara-C”，Annamycin和Ara-C的組合被稱爲“AnnAraC”）的推進給予支持，目的是治療難治性或複發性AML患者（R/R AML）在誘導治療後難以對抗。該第3期“MIRACLE”試驗（派生自分子科技R/R AML AnnAraC臨床評估）將是一項全球試驗，包括美國的試驗點。