A Phase IIa clinical trial of BioLineRx’s BL-8040, in combination with cytarabine, achieved remission rates of 41 percent in relapsed or refractory acute myeloid leukemia.

Treatment with BL-8040 at doses of 1 mg/kg and higher led to a composite complete remission rate, including both complete remission and complete remission with incomplete blood count recovery, of 38 percent in patients receiving up to two cycles. With a 1.5 mg/kg dose, selected for the expansion phase of the study, the composite rate was 41 percent, compared with the historical response rate of approximately 20 percent reported for high-risk AML patients treated with cytarabine alone, according to BioLineRx.

The study included heavily pretreated patients, as well as those who had relapsed after allogeneic stem-cell transplantation and secondary AML patients.