BIOCRYST FILES SPA FOR FODOSINE
BioCryst Pharmaceuticals has filed a special protocol assessment (SPA) with the FDA for the design of a proposed registration trial of Fodosine (forodesine hydrochloride), the company's lead transition-state analog inhibitor of purine nucleoside (PNP). The proposed trial will evaluate the efficacy and safety of Fodosine in patients with relapsed or refractory T-cell leukemia.
Fodosine is a transition-state analog inhibitor of the target enzyme PNP. The drug is currently in a Phase IIa trial for patients with T-cell leukemia and a combination IV and oral Phase I pharmacokinetic trial in healthy volunteers. Results of the Phase IIa trial and a Phase I pharmacokinetic trial will assist in the design of a planned combination IV and oral Phase IIb pivotal clinical trial in patients with T-cell leukemia.