MBRX - Moleculin gets approval to amend protocol in early-stage annamycin leukemia study

Moleculin Biotech (MBRX) has received approval for a protocol amendment for its Phase 1/2 evaluating annamycin for the treatment of certain patients with acute myeloid leukemia ((AML)).The go-ahead for the amendment came from the Bioethics Committee of the Medical University of Karol Marcinkiewicz in Pozna? as well as from the Polish Department of Registration of Medicinal Products ((URPL)).The Phase 1/2 AML trial in Poland remains ongoing and is currently dosing patients at 240 mg/m2.The amendment to the trial protocol allows for a change in the dose limiting toxicity ((DLT)) criteria as it relates to transient grade 3 elevations and allows dosing of three additional patients in the 240 mg/m2 cohort. If no DLT (as defined by the new criteria) is experienced with these next three patients, the company plans to escalate dosing in new cohorts by 30 mg/m2 instead of the 60 mg/m2 previously planned.The company expects to post topline results from the study in the second half of 2022.Shares up nearly 2% premarket.

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Moleculin gets approval to amend protocol in early-stage annamycin leukemia study