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Moleculin Receives RAMPA’s CTA Approval for P-IIb/III (MIRACLE) Study of AnnAraC in R/R AML

Shots:

  • Moleculin received approval from Georgia’s RAMPA to initiate its global P-IIb/III (MIRACLE) study of AnnAraC (Annamycin + cytarabine) in R/R AML, and first pt dosing expected by Aug-end; CTA already approved in EU
  • The study includes adaptive design; Part A will randomize 75-90 pts (1:1:1) to HiDAC + PBO or Annamycin (190 or 230 mg/m²); first unblinding (n=45) expected in H2’25; full Part B (n~220) expects to start after GLP studies
  • 7 pts already dosed at Ukraine site (ARENSIA); Annamycin holds US FDA & EMA ODD and US FDA’s FTD for R/R AML and US FDA’s ODD for soft tissue sarcoma; additionally, the company expects to activate 16 global sites by Aug’25

Ref: Globenewswire | Image: Moleculin| Press Release

Related News:- Taiho Oncology (Part of Taiho Pharmaceutical) Reports the US FDA’s sNDA Acceptance of Inqovi + Venetoclax for Newly Diagnosed AML

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