Melbourne-based ChemGenex Pharmaceuticals has treated the first patient in a new phase II/III clinical study designed to evaluate the efficacy of Ceflatonin (homoharringtonine or HHT) in patients with Chronic Myeloid Leukemia (CML) who have failed or were intolerant to treatment with two or more prior tyrosine kinase inhibitors (TKIs).
The new study is designed to complement the ongoing registration-directed clinical trial in CML patients with the T315I point mutation and will recruit CML patients from chronic, accelerated and blast-phase disease states.
The patient was enrolled into CML-203 at the MD Anderson Cancer Center in Houston, Texas, and ChemGenex is expanding the study to an estimated 15 centers through the United States and Europe.
It is anticipated that 50-75 patients will be enrolled into CML-203, and that initial data from the study will become available in the first half of calendar year 2008. The primary endpoint for the study will be hematologic response rate, and the cytogenetic response rate will be one of the secondary endpoints assessed.
Mr Greg Collier, ChemGenex's Managing Director and Chief Executive Officer, said, "This is a companion study to our ongoing CML-202 study, which will form the basis of our initial new drug application (NDA). CML-203 should provide the basis for filing a supplementary NDA, thereby expanding the potential market for the drug."