EU orphan status for BioCryst's Fodosine

12 February 2007

US firm BioCryst Pharmaceuticals says that its Fodosine, a transition-state analog inhibitor of the target enzyme purine nucleoside phosphorylase, has been granted orphan status for the treatment of cutaneous T-cell lymphoma (CTCL), by the Committee for Orphan Medicinal Products of the European Medicines Agency (EMEA).

This is the second indication for which the EMEA has granted orphan designation to Fodosine; the first was for the treatment of T-cell acute lymphoblastic leukemia (ALL), following regulatory submissions by Mundipharma, BioCryst's European partner for the product.

Fodosine, BioCryst's lead oncology candidate, is currently being studied in clinical trials for indications including T-cell acute lymphoblastic leukemia, cutaneous T-cell lymphoma, B-cell acute lymphoblastic leukemia and chronic lymphocytic leukemia. In January, the firm initiated a pivotal Phase IIb clinical trial in the treatment of patients with relapsed or refractory T-cell leukemia/lymphoma.

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