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news.BioCryst Pharmaceuticals has initiated enrollment for the pivotal trial of its oncology drug candidate, forodesine HCL, in the treatment of patients with cutaneous T-cell lymphoma.
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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 agreement between the FDA and BioCryst that was granted earlier this year.
The study will evaluate the rate of objective responses in patients enrolled at sites in the US, Europe and Australia. Eligible patients are those with cutaneous T-cell lymphoma (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.
Philip Breitfeld, executive director of oncology development and associate chief medical officer at BioCryst, said: “We are very excited that this pivotal study of forodesine HCL in CTCL has begun. 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.”