Moleculin Approved To Accelerate European Clinical Trial

Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), a clinical stage pharmaceutical company with a broad portfolio of drug candidates, today announced that it is now authorized by the Polish Department of Registration of Medicinal Products known as URPL to accelerate the Phase 1 dose escalation portion of its clinical trial of Annamycin for the treatment of acute myeloid leukemia (AML).

The URPL has allowed an amendment to the Annamycin clinical trial protocol, which among other things, includes an increase in the dose escalation increment between cohorts from 30 mg/m² to 60 mg/m². The clinical trial is currently recruiting for the 240 mg/m² cohort, so this amendment allows the next cohort to increase to 300 mg/m², assuming all requirements for safety are met with the 240 mg/m² cohort.

“Now that we have begun to demonstrate the absence of any cardiotoxicity associated with Annamycin,” commented Walter Klemp, Chairman and CEO of Moleculin. “We believe we can and should move more aggressively to establish the maximum tolerated dose, or MTD, for Annamycin. This authorization now sets the stage to accelerate the dose escalation process. Thus far, even though we’ve seen promising activity from Annamycin, our dosing levels are still sub-therapeutic. Based on prior clinical experience with Annamycin, the 300 mg/m² dosing level will be our first opportunity to test Annamycin at what we expect will be therapeutic levels.”

–PR Newswire