BioLineRx reports additional Phase IIa data for BL-8040 in AML

BioLineRx Ltd. (Tel Aviv:BLRX; NASDAQ:BLRX) reported data from the expansion portion of a Phase IIa trial in 16 patients with relapsed or refractory acute myelogenous leukemia (AML) showing that BL-8040 as monotherapy for two days followed by BL-8040 plus high-dose cytarabine for five days led to a response rate of 38% at a mean follow-up of 338 days. BL-8040 led to a median overall survival (OS) of 11.1 months, an estimated 1-year survival rate of 37.5% and a 2-year survival rate of 28.5%.

The open-label, U.S. and Israeli study's primary endpoint is safety. Secondary endpoints include pharmacokinetics, extent of mobilization of cancer cells from bone marrow to peripheral blood, apoptosis and clinical response. BioLineRx has previously reported data from the trial (see BioCentury, April 4, 2016)...