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Monday, February 14, 2022

Moleculin Biotech Annamycin Doublet Therapy Shows 68% Overall Survival In Animal Study

 Moleculin Biotech Inc 

 (Get Free Alerts for MBRX) has announced preliminary results supporting the successful conclusion of its second Phase 1 trial in Poland, evaluating Annamycin for relapsed and refractory acute myeloid leukemia (AML).

  • Moleculin determined a dose of 240 mg/m2 as the Recommended Phase 2 Dose (RP2D), subject to final approval of the Safety Review Committee, and indicated no signs of cardiotoxicity. 
  • Based on preclinical animal data, Annamycin in combination with Cytarabine demonstrated a 68% improvement in the median overall survival (OS) compared to Annamycin as a single agent and a 241% increase in OS compared to Cytarabine alone. 
  • The Company plans to advance its AML clinical development program in a Phase 1/2 clinical trial in Europe, evaluating Annamycin/Cytarabine combo.
  • The study is expected to begin in 1H 2022.
  • Annamycin has demonstrated no cardiotoxicity to date, with an ORR of 60% in the last cohort for patients receiving a full course of Annamycin.

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