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news.ChemGenex Pharmaceuticals has revealed plans to accelerate the clinical development plan for its lead anti-cancer therapeutic, Ceflatonin, with two trials scheduled to begin in the third quarter of 2005.
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The company recently came to an agreement with Swiss company Stragen Pharma in order to accelerate the development of Ceflatonin, and these trials will take advantage of Strangen’s network of trial centers in Europe.
The first phase II/III trial is scheduled for the third quarter of 2005. This trial will target chronic myeloid leukemia (CML) accelerated phase patients who are resistant to high-doses of Gleevec. It will initially be conducted in six leading European cancer centers, and is expected to expand to incorporate cancer centers in the US in the first quarter of 2006.
A second phase II/III trial will commence in the first quarter of 2006, wherein Ceflatonin will treat CML patients with a specific gene mutation that makes them resistant to tyrosine kinase inhibitors such as Gleevec (the T315I bcr-abl mutation). This study will recruit up to 85 patients.
There is growing clinical evidence that Ceflatonin has significant potential as a treatment for CML patients who are resistant to Gleevec and other experimental inhibitors.