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news.ChemGenex Pharmaceutical has treated the first patient in a new phase II/III clinical study (CML-203) evaluating Ceflatonin in patients with chronic myeloid leukemia.
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The trial is designed to test the efficacy of Ceflatonin in patients who have failed or were intolerant to treatment with prior tyrosine kinase inhibitors.
CML patients routinely receive treatment with the approved tyrosine kinase inhibitors Gleevec, developed by Novartis and Sprycel, manufactured by Bristol-Myers Squibb. Patients who are resistant or intolerant to the approved TKIs have limited treatment options. The CML-203 study is designed to evaluate whether Ceflatonin can provide clinical benefit to such patients.
The primary endpoint for the study will be hematologic response rate, and the cytogenetic response rate will be one of the secondary endpoints assessed. Interim data from the study will be released in the first half of 2008.