USA-based Hana Biosciences says that the Food and Drug Administration has granted its anticancer agent ropidoxuridine (IPdR) Orphan Drug status for the treatment of malignant glioma. The drug, which is an orally-available thymidine analog, conferred a survival advantage in Phase II studies which examined it as a therapy for anaplastic astrocytoma, a related type of brain tumor.
Hana's senior vice president, Gerg Berk, said that the FDA's decision indicates the need for a therapy for malignant glioma, which represents around half of all primary brain tumors. He added that another of its developmental compounds, talotrexin (PT-523), recently received OD designation from the FDA for the treatment of lymphoblastic leukemia.
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