Moleculin Biotech, Inc. announced the first subject has been treated in Italy in the Company's Phase 1/2 trial evaluating Annamycin in combination with Cytarabine (Ara-C) for the treatment of subjects with AML who are refractory to or relapsed after reduction therapy (MB-106). Final reported results showed one CRi (complete response with incomplete recovery of peripheral blood count) and three PRs (Partial Response). The responses in the MB-105 trial were seen in subjects 62-73 years of age and the CRi was from a subject 65 years of age.

The clicical study report for MB-105 has been finalized and the Company expects to publh detailed data in a paper or r publication in the near future. Data so far have resulted from treatment with Annamycin as a single agent, however, additional preclinical animal data from sponsored research demonstrated Annamycin in combination withCytarabine had a 68% improvement in the median overall survival (OS) compared to Annamycin as a single agents and a 241% increase in OS compared to Cytarabine alone. 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.