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news.ChemGenex has presented new clinical data supporting the use of its Ceflatonin drug in chronic myeloid leukemia patients that have developed resistance to Novartis' Gleevec, the currently approved first-line therapy.
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The data, presented at the European Hematology Association meeting in Amsterdam, looked retrospectively at 15 patients with chronic or accelerated phase chronic myeloid leukemia (CML) who had received Ceflatonin (homoharringtonine or HHT) as salvage therapy in order to achieve a complete hematologic response following treatment failure of either Gleevec or interferon.
Of the 15 patients, 11 (73.3%) achieved a complete hematologic response after a median of two courses of Ceflatonin given in single or combination therapy. These responders included one patient with accelerated phase chronic myeloid leukemia and five patients with bcr-abl point mutations, which can be associated with resistance to Gleevec and other tyrosine kinase inhibitors. Only one of the six patients with a detected bcr-abl mutation in the study did not respond to Ceflatonin therapy.
Nine of the patients experienced grade 4 hematologic toxicities, but there was no significant extra-hematologic toxicity reported.
“These results add to the growing body of clinical data that support the potential of HHT as a therapy for CML, especially in the increasing population of patients who have developed bcr-abl mutations associated with resistance to tyrosine kinase inhibitor therapies,” said Dr Greg Collier, ChemGenex’s Managing Director and CEO.
The company has recently initiated a multi-national phase II/III study of Ceflatonin in patients who have developed resistance to Gleevec.