KANSAS CITY, Mo., June 10 /PRNewswire/ -- BBCI, an international contract research organization, announced that it is providing clinical trial management services to BioCryst Pharmaceuticals, Inc. for its recently initiated Phase IIa trial with forodesine hydrochloride, a purine nucleoside phosphorylase (PNP) inhibitor that is currently in clinical development for treatment of T-cell cancers. Forodesine hydrochloride, a small-molecule drug which causes biochemical changes that result in blocking of the T-cell's DNA synthesis machinery, recently received orphan drug designation from the U.S. Food and Drug Administration for treatment of T-cell non-Hodgkin's lymphoma.
The Phase II clinical trial being managed by BBCI is a multi-center, global, open-label study to determine the efficacy of long-term dosing with forodesine hydrochloride. The trial will be divided into two parts, Phase IIa and IIb. The Phase IIa study will evaluate response rate and duration of response in 20 patients with refractory T-cell leukemia who have failed or relapsed previous treatment. Assuming the clinical data from the first part of the trial is sufficiently positive, BioCryst expects to initiate a larger Phase IIb study of up to 100 patients at cancer centers in both the U.S. and Europe.
BioCryst Pharmaceuticals, Inc. designs, optimizes and develops novel drugs that block key enzymes essential for cancer, cardiovascular and autoimmune diseases, and viral infections. BioCryst integrates the necessary disciplines of biology, crystallography, medicinal chemistry and computer modeling to effectively use structure-based drug design to discover and develop small-molecule pharmaceuticals. For more information about BioCryst, please visit the company's web site at http://www.biocryst.com/ .
BBCI is an international Contract Research Organization dedicated to delivering on-time, reliable clinical trial management services to clients around the world. BBCI has been providing quality results in managing Phase II-IV studies for more than 28 years and has extensive surveillance experience in every major therapeutic area, with more than 100,000 patients enrolled in studies during the past five years, with particular emphasis on late-stage drug development. More information about BBCI can be found at http://www.bbclinical.com/ , or by calling 1-800-366-8531.
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