BioCryst Initiates Enrollment in Pivotal Trial of Forodesine HCL in Patients with Cutaneous T-Cell Lymph...( BIRMINGHAM Ala. Oct. 12 /- BioCry...),Health

BIRMINGHAM, Ala., Oct. 12 /PRNewswire-FirstCall/ -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that it has initiated enrollment of the pivotal trial of its lead oncology drug candidate, forodesine HCL, in the treatment of patients with cutaneous T-cell lymphoma (CTCL).

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The multinational trial, which will evaluate once daily oral forodesine HCL treatment, will be conducted in accordance with a Special Protocol Assessment (SPA) agreement between the U.S. Food and Drug Administration (FDA) and BioCryst which was granted earlier this year. The study will evaluate the rate of objective responses in patients enrolled at sites in the United States, Europe, and Australia. Eligible patients are those with CTCL of Stages IB through IVA who have disease that is persistent, progressive or recurrent during or after treatment with at least three systemic therapies. The study's primary endpoint is to determine the objective response rate, defined as either complete response or partial cutaneous response that is sustained for at least 28 days. Secondary endpoints include assessing the safety and tolerability of extended daily treatment with oral forodesine HCL, assessment of the time to objective response and the duration of objective response.

"We are very excited that this pivotal study of forodesine HCL in CTCL has begun," said Philip P. Breitfeld, M.D., Executive Director, Oncology Development and Associate Chief Medical Officer of BioCryst. "Based on the encouraging results we saw in an earlier study, we believe that this pivotal trial should
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