On December 3, 2020 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 will present animal data demonstrating highly improved activity against acute myeloid leukemia ("AML") in combination with the commonly used antileukemic drug Ara-C (also referred to as "cytarabine") versus single agent at the 62nd Annual Meeting & Exposition of the American Society for Hematology ("ASH") under the title: "High Efficacy of Liposomal Annamycin (L-ANN) in Combination with Cytarabine in Syngeneic p53-null AML Mouse Model (Press release, Moleculin, DEC 3, 2020, View Source [SID1234572133])."

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Moleculin Biotech, Inc. is a clinical stage pharmaceutical company focused on the development of a broad portfolio of oncology drug candidates for the treatment of highly resistant tumors. (PRNewsfoto/Moleculin Biotech, Inc.)

"We are extremely encouraged by the strong pre-clinical efficacy demonstrated by the combination of Annamycin and Ara-C against AML," commented Walter Klemp, Chairman and CEO of Moleculin. "While we firmly believe in the promise and efficacy Annamycin has demonstrated as a single agent against AML in our two current Phase 1 clinical trials, we believe this discovery warrants further consideration to the potential expansion of its clinical development into clinical trials for the combination of Annamycin with Ara-C ("AnnAraC") against AML."

Mr. Klemp concluded, "The combination of Annamycin with Ara-C is particularly intriguing considering the current first-line therapy for AML patients is "7+3", where Ara-C is administered daily for 7 days in parallel with 3 daily doses of an anthracycline. Substituting a currently used anthracycline such as doxorubicin with Annamycin would be a familiar and well-practiced treatment modality. Furthermore, the combination of Annamycin with Ara-C may offer potential advantages given Annamycin’s demonstrated lack of cardiotoxicity and activity against tumor cells resistant to doxorubicin. We look forward to further discussing the promise of this combination at the 62nd Annual Meeting & Exposition of the American Society for Hematology."

As previously announced, the study was conducted in a highly aggressive AML mouse model where median survival, left untreated, is approximately 13 days. Median survival in animals treated with the combination of Annamycin and Ara-C ranged from 56 to 76 days, expanding median survival by 585%. Notably, several animals in the study were completely cured. The Company believes these experiments support initiation for the clinical development of the combination of Annamycin and Ara-C in AML patients.