BIOCRYST RECEIVES FDA FAST-TRACK STATUS FOR FODOSINE

BioCryst Pharmaceuticals has announced that the FDA has granted "fast-track" status to the development of Fodosine, for the treatment of relapsed or refractory T-cell leukemia. Fodosine (forodesine HCl) is a transition state analog inhibitor with especially strong binding to the target enzyme.

The FDA informed BioCryst that it granted fast-track designation for the following reasons: Because of the life-threatening nature of the disease and based on clinical responses observed in clinical studies.

Fodosine, is a transition-state analog inhibitor of the target enzyme purine nucleoside phosphorylase. The drug is currently in a Phase IIa trial for patients with T-cell leukemia and a Phase I trial with an oral formulation in cutaneous T-cell lymphoma. BioCryst also plans to initiate a Phase I/II trial in B-cell acute lymphoblastic leukemia and a Phase II trial in chronic lymphocytic leukemia during 2005.