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Hana Biosciences Receives Orphan Drug Status For Drug In Treatment Of Brain Tumor - Update
Friday, June 09, 2006
Hana Biosciences Inc., a biopharmaceutical company, said its drug Ropidoxuridine or IpdR indicated in the treatment of brain tumor in adults, was accorded orphan drug status by the U.S. Food and Drug Administration. The orphan drug designation enables the company to make quick progress in developing the target drug with entitlement to economic incentives and exclusivity for marketing over a period of time.
The South San Francisco, California-based company is currently in the Phase II stage of Ropidoxuridine clinical trials which is indicated in the treatment of malignant glioma, which makes up for over 42% of all brain tumors. Plans are on for furthering the Phase I/II clinical trials for malignant glioma. The company was also recently granted orphan drug status for its Talotrexin in the treatment of acute lymphoblastic leukemia.
Ropidoxuridine is a thymidine analogue and prodrug for IUdR that is orally available. The trial studies have also indicated Ropidoxuridine has dose responsive and synergistic effects when combined with radiation in glioblastoma models. Studies had indicated encouraging survival patterns in anaplastic astrocytoma, a type of brain tumor that originates in the brain, in subjects during the study. The company states that Ropidoxuridine reduced toxicity, with better tissue incorporation and improved anti-tumor activity when compared to IUdR in nonclinical models. Ropidoxuridine is also in the Phase I clinical trial stage for the treatment of patients with solid tumors such as colorectal, gastric, and pancreatic cancer. In addition, a Phase I/II clinical trial in malignant glioma is planned.
Greg Berk, M.D., Senior Vice President and Chief Medical Officer, Hana Biosciences, said, "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."
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