HANA BIOSCIENCES RECEIVES ORPHAN DRUG DESIGNATION FOR TALOTREXIN

The FDA has granted Hana Biosciences orphan drug designation for Talotrexin (PT-523) in patients with acute lymphoblastic leukemia (ALL). Talotrexin, a novel nonpolyglutamatable antifolate drug, is currently being evaluated in a Phase I/II multicenter clinical trial in patients with relapsed or refractory ALL.

Antifolates, also known as folic acid analogs, are a class of cytotoxic or antineoplastic agents which inhibit or prevent the maturation and proliferation of malignant cells. Antifolates have been used for more than 30 years to treat both solid and hematological cancers such as breast cancer and ALL, as well as inflammatory diseases such as rheumatoid arthritis.