Late-stage pharmaceutical company Moleculin Biotech Inc (Nasdaq: MBRX) announced on Tuesday that it has received first country regulatory approval in Europe to commence recruitment for its Phase 3 pivotal trial protocol assessing Annamycin along with Cytarabine (also known as 'Ara-C' and for which the combination of Annamycin and Ara-C is referred to as 'AnnAraC') for the treatment of acute myeloid leukaemia patients who are refractory to or relapsed after induction therapy (R/R AML) (MB-108).

In Ukraine, the final necessary regulatory approvals from the Ministry of Health were received last week.

The global trial will include sites in the United States, Europe and the Middle East.

Subject to future filings with and potential additional feedback from the FDA and its foreign equivalents, the MIRACLE study utilises an adaptive design whereby the first 75 to 90 subjects will be randomised (1:1:1) in Part A of the trial to receive high dose cytarabine (HiDAC) combined with either placebo, 190 mg/m2 of Annamycin or 230 mg/m2 of Annamycin.

For Part B of the trial, approximately 244 additional subjects will be randomised to receive either HiDAC plus placebo or HiDAC plus the optimum dose of Annamycin (randomised 1:1). Selection of the optimum dose will be based on the overall balance of safety, pharmacokinetics and efficacy, consistent with the FDA's new Project Optimus initiative. This increase from 240 to 244 subjects represents the statistical 'cost' of the additional interim unblinding.