Moleculin’s Annamycin Gains FDA Orphan Drug Status

Moleculin’s anthracycline chemotherapy drug annamycin has earned its second Orphan Drug designation from the FDA, this time for the treatment of soft-tissue sarcomas.

The Houston, Tex.-based biotech previously earned Orphan Drug designation for annamycin for treating relapsed or refractory acute myeloid leukemia. The drug is designed to avoid multidrug-resistance mechanisms with little to no cardiotoxicity.

The agency recently gave Moleculin the go-ahead to begin a phase 1b/2 clinical trial of annamycin for patients with soft-tissue sarcoma that has metastasized to the lungs after first-line therapy.