US-based pharmaceutical company Moleculin Biotech has received approval from Ukraine’s Ministry of Health to begin enrolment in its Phase III trial of annamycin with cytarabine for treating acute myeloid leukaemia (AML).
The MIRACLE trial will take place at sites across Europe, the Middle East and the US, enrolling AML patients who are refractory to or relapsed post-induction therapy.
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It will follow an adaptive design, initially randomising the first 75-90 participants in Part A to receive high-dose cytarabine with either a placebo or one of two doses (190 mg/m² or 230 mg/m²) of Annamycin, as recommended by the Food and Drug Administration (FDA).
Moleculin said that the amended protocol enables the unblinding of preliminary primary efficacy data and safety/tolerability outcomes for the three treatment arms at 45 participants.
This early unblinding will involve 30 participants receiving the combination of annamycin and cytarabine, while the other 15 will only be given high-dose cytarabine.
The first unblinding is anticipated in the second half of this year, with a second to follow early next year.
Part B of the trial will involve nearly 244 additional participants and will aim to determine the optimum dose of annamycin based on safety, pharmacokinetics and efficacy.
Moleculin chairman and CEO Walter Klemp said: “We continue to make solid progress across our site initiation and enrolment efforts.
“Achieving this important milestone of receiving our first country’s approval puts us another step closer to getting this study well underway and further bolsters our confidence that we’re on track for unblinded preliminary data from the first 45 subjects in the second half of this year.”
Based in Texas, Moleculin Biotech develops therapeutic candidates for a range of tumours and viruses that are considered difficult to treat.
In May last year, the company began a Phase II trial of WP1066 with radiation therapy for glioblastoma.
