On December 21, 2017 Moleculin Biotech, Inc., (NASDAQ: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on license agreements with The University of Texas System on behalf of the MD Anderson Cancer Center ("MD Anderson"), reported that the Ethics Committee in Poland has approved the Company’s Phase I/II clinical trial of Annamycin for the treatment of relapsed or refractory acute myeloid leukemia ("AML") (Press release, Moleculin, DEC 21, 2017, View Source [SID1234522757]).

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"We have been highly focused on accelerating our clinical development of Annamycin," commented Walter Klemp, Chairman and CEO of Moleculin. "The protocol approved in Poland allows us to move more aggressively in identifying the optimum dosing for AML patients, which in turn should allow us to move into Phase II data generation more expeditiously."

Mr. Klemp added, "This approval should also increase our ability to recruit patients into our AML trial, which we expect to begin in a matter of weeks. Importantly, we believe the clinical data produced in Poland will be useful in our interactions with both the U.S. Food and Drug Administration ("FDA"), as well as with the European Medicines Agency ("EMA"), as we seek regulatory approval for Annamycin."

A site initiation visit for the first treatment site was completed this week and treatment of patients in Poland is now subject only to confirmation by the Polish National Office that all necessary forms have been properly filed. The Company expects the first patient to be enrolled in first quarter 2018.