BioCryst says research shows promising results for Fodosine in leukemia

By Ted A. Knutson

Washington, Dec. 12 - BioCryst Pharmaceuticals, Inc. said Monday new research indicates Fodosine (forodesine hydrochloride) may represent an important option as a single agent in treating relapsed or refractory T-cell leukemia.

This phase 2a multi-center trial of intravenous Fodosine evaluated 23 relapsed or refractory T-cell leukemia patients. The overall response rate for these patients was 35%, including five patients with complete response (22%) and three patients with partial response (13%).

Restoration of normal hematopoiesis was observed in patients while on therapy, indicating that Fodosine may offer a less toxic T-ALL therapy.

Based on these encouraging results, the company said it plans to begin a phase 2b trial, pending approval of Special Protocol Assessment from the Food and Drug Administration.

Additional research presented at the 47th Annual Meeting and Exposition of the American Society of Hematology on Fodosine support the concept that inhibition of purine nucleoside phosphorylase (PNP) is sufficient for the initiation of apoptosis in malignant B-cells.

These results have led to the start of a phase 2 study of oral Fodosine in patients with advanced, fludarabine-refractory chronic lymphocytic leukemia (CLL), the first trial of a PNP inhibitor for the treatment of CLL.

In a phase 1/2, open-label, dose escalating study of oral Fodosine in patients with refractory cutaneous T-cell lymphoma (CTCL) where safety, pharmacokinetics and pharmacodynamics, the maximum tolerated dose, and preliminary evidence of efficacy of oral Fodosine were assessed the drug was well tolerated and no dose-limiting toxicity was reached in the CTCL patients.

This trial, which evaluated 14, relapsed or refractory CTCL patients, showed Fodosine was orally bioavailable with a long terminal half-life.

Additionally an optimum biological dose was identified for use in evaluating clinical effects in CTCL patients dosed for extended periods.

BioCryst is a Birmingham, Ala., pharmaceutical company that designs, optimizes and develops novel drugs that block key enzymes involved in cancer, cardiovascular diseases, autoimmune diseases and viral infections.

The announcement was made in an 8-K filing with the Securities and Exchange Commission.

© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere. For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.