Hana Biosciences' anticancer drug candidate ropidoxuridine has been granted orphan drug designation by the FDA for the treatment of malignant glioma, which makes up approximately half of all primary brain tumors.
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Orphan drug designation entitles Hana Biosciences to seven years of market exclusivity for ropidoxuridine in the treatment of malignant glioma. 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.
Ropidoxuridine is a novel, orally available, thymidine analogue and prodrug for IUdR, which demonstrated a survival advantage in phase II studies in anaplastic astrocytoma, a type of brain tumor. Hana Biosciences also recently received orphan drug designation for Talotrexin for the treatment of acute lymphoblastic leukemia.
“This designation not only underscores the need for improved therapies in malignant glioma, it also reiterates the company’s development strategy in areas of unmet need. Hana Biosciences is committed to the clinical development of ropidoxuridine in this disease,” commented Dr Greg Berk, senior vice president and chief medical officer of Hana Biosciences.