Moleculin Biotech (MBRX) said Tuesday it received regulatory approval in Ukraine to start recruiting for a phase 3 trial of annamycin plus cytarabine to treat relapsed or refractory acute myeloid leukemia, a type of cancer.
The first 75 to 90 subjects in the trial's part A will receive high-dose cytarabine, or HiDAC, combined with either placebo or various doses of annamycin, the company said.
For part B, roughly 244 additional subjects will receive either HiDAC plus placebo or HiDAC plus the optimum dose of annamycin, up from 240 subjects. Moleculin said the increase in the number of subjects represents the "statistical 'cost' of the additional interim unblinding."
Moleculin Biotech said it remains on track to treat a first subject in the phase 3 trial in Q1.
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