Moleculin Biotech Inc (NASDAQ: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.
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- 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.
- Price Action: MBRX shares are down 2.70% at $1.44 during the market session on the last check Monday.
