Moleculin Biotech treats first subject in Italy in Phase 1/2 trial of Ara-C

Moleculin Biotech announced the first subject has been treated in Italy in the Company’s Phase 1/2 trial evaluating Annamycin in combination with Cytarabine, or Ara-C, for the treatment of subjects with AML who are refractory to or relapsed after induction therapy. 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, respectively. Highlights from the final data demonstrated in the MB-105 study include: MB-105 demonstrated 80% overall response rate (ORR) in final cohort for treatment of relapsed/refractory acute myeloid leukemia; final reported results showed one CRi and three PRs; 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.