Belinostat enters Ph I/II trial

Copenhagen, Denmark-based TopoTarget AS and US firm CuraGen have initiated patient dosing in a Phase I/II trial evaluating belinostat (PXD101), their co-developed histone deacetylase (HDAC) inhibitor, in combination with the anthracycline idarubicin for the treatment of acute myeloid leukemia (AML).

Patients under the age of 60 with relapsed or refractory AML, or those aged over 60 with newly-diagnosed or previously treated AML, are eligible for enrollment in the trial. Initially, 24 to 40 patients will be recruited into one of two treatment arms and receive intravenous therapy with a combination of belinostat and idarubicin. Enrollment into the arms will occur in parallel in order to assess safety and define the maximum-tolerated dose for each regimen.

The primary objectives for the study include safety, tolerability and efficacy for each treatment regimen. Secondary objectives include time to response, duration of response and survival. The trial will also include pharmacokinetic and pharmacodynamic studies to evaluate the inhibition of HDAC enzymes in AML cells from patients treated with the agent.