Moleculin Biotech treats first patients in Phase 1/2 Annamycin trial, requests fast track designation
Moleculin Biotech (NASDAQ:MBRX) has treated the first patients in its European Phase 1/2 clinical trial of Annamycin for relapsed and refractory acute myeloid leukemia (AML). The company also submitted a request to the FDA for the drug candidate’s fast track designation.
Developed with the MD Anderson Cancer Institute, Annamycin is a next generation anthracycline that is believed to have a better safety and efficacy profile than currently approved anthracyclines, particularly lower cardiotoxicity and multidrug resistance.
First-line therapy fails in approximately 80% of AML patients. In two of the company’s previous trials, Annamycin - administered as a second-line AML therapy - generated significant activity in patients where first-line therapy has failed.