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news.BioCryst Pharmaceuticals (BioCryst) has achieved its protocol-specified objective of enrolling 100 late-stage patients (Stage IIB to IVA) in its pivotal study for Forodesine. The trial is intended for the treatment of cutaneous T-cell lymphoma (CTCL), and the top-line results are expected in the second half of 2010.
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Currently, over 143 patients are enrolled in the CTCL study. The study is a multinational, non-randomised, open-label, single-arm trial, evaluating 200mg once-daily oral Forodesine treatment.
Reportedly, the study is expected to examine the rate of objective responses in patients enrolled at sites in North America, Europe and Australia. The primary endpoint is objective response rate, defined as either complete response or partial cutaneous response, that is sustained for at least 28 days.
The trial is being conducted under a Special Protocol Assessment (SPA) agreement negotiated with the FDA and will serve as a basis for a new drug application (NDA).
Additionally, BioCryst’s exploratory phase 2 study for Forodesine in subjects with chronic lymphocytic leukemia (CLL) is continuing to progress and has enrolled over half of its targeted number of patients.
The phase 2 study for Forodesine in subjects with CLL has enrolled 15 of the targeted 26 patients, with 12 patients currently still on treatment. The primary purpose of the study is to evaluate the effectiveness and safety of oral forodesine administered as monotherapy at a dose of 200mg twice-daily in relapsed CLL patients.
Previous clinical trial data indicated that Forodesine has demonstrated clinical activity in CLL patients at a dose of 200mg once-daily, and was generally safe and well-tolerated. The current trial is testing the benefit and safety of increasing Forodesine drug exposure with twice-daily dosing.
William Sheridan, chief medical officer at BioCryst, said: “Reaching this milestone for the CTCL pivotal study is an important event for the development of forodesine, and will enable a complete analysis of the trial results once protocol-specified patient follow-up has been concluded. Also, we are pleased with progress in the CLL Phase 2 study and look forward to completing enrollment.”