Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.BioCryst Pharmaceuticals has filed a special protocol assessment with the FDA for the design of a proposed registration trial of the company's lead investigational drug, Fodosine. The proposed trial will evaluate the drug in patients with relapsed or refractory T-cell leukemia.
Subscribe to our email newsletter
Fodosine, is a transition-state analog inhibitor of the target enzyme purine nucleoside phosphorylase (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 and the 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.
Additionally, Fodosine is currently being studied in a phase I trial with an oral formulation in cutaneous T-cell lymphoma (CTCL) and a phase II trial in chronic lymphocytic leukemia (CLL). BioCryst also plans to initiate a phase I/II trial in B-cell acute lymphoblastic leukemia during 2005.
Fodosine has been granted Orphan Drug status by the FDA for three indications: T-cell non-Hodgkin’s lymphoma, including CTCL; CLL and related leukemias including T-cell prolymphocytic leukemia, adult T-cell leukemia, and hairy cell leukemia; and for treatment of acute lymphoblastic leukemia (ALL).
The FDA has also granted fast track status to the development of Fodosine for the treatment of relapsed or refractory T-cell leukemia. A phase Ib study with BioCryst’s second-generation PNP inhibitor, BCX-4208, was recently initiated and is being conducted with the goal of initiating a phase I/II study in patients with psoriasis in late 2005 or early 2006.