Hana Bioscience receives orphan drug designation for Talotrexin for the treatment of acute lymphoblastic leukemia


Hana Biosciences announced that the U.S. food and Drug Administration has granted 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.

"This designation underscores the need for improved therapies in ALL, and supports our development strategy in areas of unmet need. Hana Biosciences is committed to accelerating the clinical development of Talotrexin in this disease," commented Greg Berk, MD, Senior Vice President and Chief Medical Officer of Hana Biosciences.

Talotrexin, which Hana licensed from Dana-Farber Cancer Institute, Inc. (DFCI) and Ash Stevens, Inc. in December 2002, is a novel antifolate drug candidate under development for treatment of various types of tumors. 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.

Talotrexin has demonstrated enhanced antitumor activity in a broad spectrum of cancer models by targeting the enzyme DHFR to prevent DNA synthesis in tumor cells and inhibit tumor growth. Preclinical studies performed by the DFCI and the National Cancer Institute suggest that Talotrexin, as compared to methotrexate, the most widely used antifolate, enters into cells up to 10 times more efficiently and demonstrates 10- to 100-fold more potency in overcoming polyglutamation, a well-established mechanism of antifolate resistance. Talotrexin also binds more tightly to its anti-tumor target DHFR, which Hana believes may further inhibit tumor growth.

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