Moleculin Biotech’s Annamycin shows effiay in Phase 1B/2 lung sarcoma trial

Moleculin Biotech announced the presentation of preliminary efficacy findings from the Phase 2 portion of the company’s ongoing U.S. Phase 1B/2 clinical trial evaluating Annamycin for the treatment of soft tissue sarcoma lung metastases. Annamycin is the company’s next-generation anthracycline that has been shown in animal models to accumulate in the lungs at up to 30-fold the level of doxorubicin. There were no significant safety concerns or unexpected serious adverse events up to the 390 mg/m2 dose. The recommended Phase 2 dose was defined as 330 mg/m2. The most frequently reported adverse events related to Annamycin were in the system organ class of Investigations. There was no evidence of cardiotoxicity. Of the 14 subjects enrolled in the Phase 2 portion of the trial, 9 showed stable disease through 2 cycles, 5 of whom continued to show SD through 4 cycles, and 2 showed SD through 6 cycles. 3 subjects continue to be followed for progression free survival and 12 of 14 subjects in the Phase 2 efficacy population continue to be followed for overall survival. Annamycin currently has Fast Track Status and Orphan Drug Designation from the FDA for the treatment of soft tissue sarcoma, in addition to Orphan Drug Designation for the treatment of relapsed or refractory acute myeloid leukemia.