BioCryst Initiates Enrollment in Pivotal Trial of Forodesine HCL in Patients with Cutaneous T-Cell Lymphoma (CTCL)
Friday October 12, 7:00 am ET
BIRMINGHAM, Ala., Oct. 12 /PRNewswire-FirstCall/ -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX - News) 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 provide data to establish forodesine HCL as a new treatment alternative for CTCL patients who have not responded to currently available therapies."
"Initiation of this pivotal trial is a great step forward toward our goal of getting our late-stage pipeline products to market," said Jon P. Stonehouse, President and Chief Executive Officer of BioCryst.
Forodesine HCL is a transition-state analog inhibitor of the target enzyme purine nucleoside phosphorylase (PNP). In addition to CTCL, the drug is currently being studied in clinical trials for indications including T and B- cell leukemia (T-ALL, B-ALL), and chronic lymphocytic leukemia (CLL).
About BioCryst
BioCryst Pharmaceuticals, Inc. is a leader in the use of crystallography and structure-based drug design for the development of novel therapeutics to treat cancer, cardiovascular diseases, autoimmune diseases, and viral infections. The company is advancing multiple internal programs toward potential commercialization including forodesine HCL in oncology, BCX-4208 in transplantation and autoimmune diseases and peramivir in seasonal and life- threatening influenza. BioCryst has a worldwide partnership with Roche for the development and commercialization of BCX-4208, and is collaborating with Mundipharma for the development and commercialization of forodesine HCL in markets across Europe, Asia, Australia and certain neighboring countries. In January, 2007 the U.S. Department of Health and Human Services (DHHS) awarded a $102.6 million, four-year contract to BioCryst for advanced development of peramivir to treat seasonal and life-threatening influenza. In February 2007 BioCryst established a partnership with Shionogi & Co., to develop and commercialize peramivir in Japan. For more information about BioCryst, please visit the company's web site at biocryst.com. |
