India, June 30 -- Moleculin Biotech, Inc. (MBRX) announced positive interim efficacy results from Part A of its pivotal Phase 2/3 MIRACLE trial evaluating Annamycin in patients with relapsed or refractory acute myeloid leukemia. The analysis, based on the first 45 patients enrolled, showed that both Annamycin dose arms significantly outperformed the control arm on the primary endpoint of complete remission.
Complete remission (CR) rates reached 43% and 35% in the respective Annamycin cohorts compared with 12% for the control arm, while composite complete remission (CRc) rates were 50% and 57% versus 29% for control.
The trial population included a high proportion of older patients, with 75.6% over 60 years of age, and prior exposure to in...