The patients being enrolled in the trial have chronic, accelerated and blast-phase chronic myeloid leukemia (CML) and have the T315I bcr-abl point mutation, which is associated with resistance to treatment with Gleevec and two known tyrosine kinase inhibitors (TKIs) currently under development.
The study will be conducted in both the US and Europe and is projected to enroll up to 81 patients within 12 months. The primary endpoint will be hematologic response rate, and the secondary endpoint will be cytogenetic response rate.
“Demonstration of positive results in CML patients with the T315I mutation may serve as the basis for filing for an NDA with the FDA under an accelerated approval, based on a high level of unmet medical need,” said Dr Greg Collier, CEO and Managing Director of ChemGenex.
In other developments, a recent preclinical study presented at the American Association of Cancer Research conference showed that Ceflatonin is active as a single-agent and in-combination with other agents, including Gleevec, in CML cell lines with the T315I bcr-abl point mutation.