On December 21, 2022 Moleculin Biotech, Inc., (Nasdaq: MBRX) (Moleculin or the Company), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors and viruses, reported that it has received approval from the Agenzia Italiana del Farmaco (AIFA, the Italian Medicines Agency competent authority) and the Istituto Superiore di Sanità (ISS, the Italian National Institute of Health) for its Phase 1/2 trial evaluating Annamycin in combination with Cytarabine (Ara-C) in the treatment of subjects with AML who are refractory to or relapsed after induction therapy (MB-106) (Press release, Moleculin, DEC 21, 2022, View Source [SID1234625491]). This adds to the approval the Company already has in Poland where three sites are currently open and recruiting subjects. Additionally, the Company has ongoing efforts to open additional clinical sites in Poland and Italy and gain approval to proceed in other European countries for the MB-106 clinical trial to potentially improve recruitment rates.

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"We are pleased to receive authorization to expand our MB-106 trial into Italy. This marks an important milestone in the global expansion of our AML development program. Based on the encouraging data seen to date from the successfully concluded single agent trials, we remain very optimistic in Annamycin’s potential to treat refractory or relapsed AML in combination with Cytarabine. We are committed to driving enrollment and our team is working diligently to bring additional sites online and enroll subjects for the study," commented Walter Klemp, Chairman and CEO of Moleculin. He continued, "In Poland we expect the first subject to be treated in MB-106 to be in the near term."

Annamycin is the Company’s next-generation anthracycline that has been designed to be non-cardiotoxic and has been shown in animal models to accumulate in the lungs at up to 30-fold the level of doxorubicin (a commonly prescribed anthracycline), as well as demonstrating the ability to avoid the multidrug resistance mechanisms that typically limit the efficacy of doxorubicin and other currently prescribed anthracyclines. Annamycin is currently in development for the treatment of relapsed or refractory AML and STS lung metastases and the Company believes it may have the potential to treat additional indications.

The Phase 1/2 MB-106 trial is an open label trial that builds on the safety and dosage data from the two successfully concluded single agent Annamycin AML Phase 1 trials (MB-104 and MB-105) conducted in the U.S. and Europe. Additionally, the preclinical animal data from sponsored research demonstrated Annamycin in combination with Cytarabine had a 68% improvement in the median overall survival (OS) compared to Annamycin as a single agent and a 241% increase in OS compared to Cytarabine alone.1 Subject enrollment and screening for the MB-106 trial is underway and the Company expects to initiate subject treatment in the near term and the first subject to be treated in Italy in the first quarter of 2023.

1 Zal T, Zielinski R, Grela K, Cardenas-Zuniga R, Skora S, Fokt I, Zal A, Andreeff M, Gil L Shephard R, Priebe W, High Efficacy of Liposomal Annamycin (L-ANN) in Combination with Cytarabine in Syngeneic p53-Null AML Mouse Model, Blood (2020) 136 (Supplement 1): 6-7. View Source

Annamycin currently has Fast Track Status and Orphan Drug Designation from the US Food and Drug Administration (FDA) for the treatment of STS lung metastases and the treatment of relapsed or refractory AML. For more information about the MB-106 Phase 1/2 trial, visit clinicaltrialsregister.eu and reference EudraCT 2020-005493-10 or clinicaltrials.gov and reference NCT05319587.