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news.Australian company ChemGenex has presented new phase II data supporting the use of Ceflatonin in combination with Novartis' Gleevec to treat chronic myeloid leukemia patients.
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Ceflatonin is for use in chronic myeloid leukaemia (CML) patients who have developed resistance to Gleevec and other tyrosine kinase inhibitors.
Following treatment with the drug combination, 42% of patients achieved a hematologic response (reduction of leukemic cells in the blood), consisting of three complete hematologic responses (CHR) and two hematologic improvements. Two of the three patients showing a CHR also achieved complete cytogenic responses (no Ph+ leukemic cells in the blood).
The patients treated in this study had failed a median of three prior therapies, including the tyrosine kinase inhibitors Gleevec, Sprycel and Tasigna. Mutations in the Bcr-Abl kinase domain were identified in 33% of patients, including one patient with the T315I mutation known to be associated with resistance to tyrosine kinase inhibitors.
The authors concluded that the combination therapy of Ceflatonin and Gleevec “is well tolerated and has clinical activity in patients in CML in all phases, including in some who have failed prior therapy with imatinib mesylate and other tyrosine kinase inhibitors”.
ChemGenex is currently treating patients in a phase II/III clinical trial of Ceflatonin as a single agent, with the goal of completing enrollment in that trial by H2 2007.