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news.Cancer-focused drug developer Hana Biosciences has been granted FDA orphan drug designation for Talotrexin in patients with acute lymphoblastic leukemia, a type of cancer that almost 4,000 Americans are diagnosed with each year.
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Talotrexin (PT-523), a novel nonpolyglutamatable antifolate drug, is currently being evaluated in a phase I/II multicenter clinical trial in patients with relapsed or refractory acute lymphoblastic leukemia (ALL).
The novel drug candidate was licensed from Dana-Farber Cancer Institute and Ash Stevens in December 2002, and is under development for treatment of various types of tumors. Indeed, in addition to the phase I/II ALL trial, Hana has commenced a phase I clinical trial in solid tumors and a phase I/II clinical trial in non-small cell lung cancer.
Orphan drug designation entitles Hana Biosciences to seven years of market exclusivity for Talotrexin in the treatment of ALL. Additional incentives include tax credits related to clinical trial expenses, a possible exemption from the FDA-user fee, and assistance in clinical trial protocol design.
“This designation underscores the need for improved therapies in ALL, and supports our development strategy in areas of unmet need,” commented Dr Greg Berk, senior vice president and chief medical officer of Hana Biosciences. “Hana Biosciences is committed to accelerating the clinical development of Talotrexin in this disease.”