Moleculin Biotech, Inc. announced the completion of its Phase 1B/2 clinical trial evaluating Annamycin in combination with Cytarabine for the treatment of AML.
Results showed significant improvements in overall survival rates compared to industry expectations for relapsed AML patients.
The company continues to execute Part A of the pivotal MIRACLE Phase 3 trial.
Median Overall Survival (OS)
15 months for subjects with complete remission (n=8)
Intent to Treat Population (1L-7L)
Median OS of 9 months for the population (n=22)
Second Line Population
Median OS of 12 months for efficacy evaluable population (n=9)
CR Rate in ITT Population
36% of subjects achieved complete remission (CR)
- The results demonstrated a 30% improvement in overall survival compared to industry standards for relapsed AML patients.
- 50% of subjects achieving CR moved on to a curative bone marrow transplant, a significant achievement in AML treatment.
The positive outcomes of the Phase 1B/2 clinical trial highlight the potential of Annamycin in treating AML, offering hope for improved outcomes and addressing the unmet need in second-line AML treatment.