Cutaneous T-Cell Lymphoma

BioCryst Receives Special Protocol Assessment for Pivotal Trial of Oral Fodosine in Patients With Cutaneous T-Cell Lymphoma (CTCL)

Published in Drug Week, July 27th, 2007

BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) announced that it has reached an agreement with the U.S. Food and Drug Administration (FDA) under the FDA's Special Protocol Assessment (SPA) process for the design of its planned pivotal clinical trial of the oral formulation of the company's lead oncology compound, Fodosine(TM) (forodesine hydrochloride) in patients with cutaneous T-cell lymphoma.

A Special Protocol Assessment is a request for feedback from the FDA that allows a company to receive official evaluation and guidance on the design of pivotal trial protocols. BioCryst requested the formal assessment, late in the first quarter of 2007, because the pivotal trial...

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Source: Drug Week (2007-07-27)

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