BioLineRx begins enrolling acute myeloid leukaemia patients in Phase 2 trial of BL-8040

Subsequent to the approval to commence the trial by the US and Israel regulatory bodies, patient enrollment has commenced in the US and will begin in Israel upon the activation of sites in the next few weeks.

With first patient enrolled at the MD Anderson Cancer Center in Houston, Texas, the multicenter study will enroll 50 adult patients at eight sites in the US and Israel.

BioLineRx CEO Kinneret Savitsky said BL-8040’s Phase 2 trial has begun at MD Anderson cancer research centre.

"We anticipate that additional world-leading cancer research centers in the U.S. will join MD Anderson in this promising Phase 2 trial," Savitsky added.

"Considering the compound’s unique biological pathway and its promising pre-clinical results, BioLineRx and its clinical partners are enthusiastic about BL-8040."

Designed to assess the safety and efficacy profile of repeated escalating doses of BL-8040, the study’s primary endpoints include drug safety and tolerability

Secondary endpoints of the open-label study under an IND are to assess pharmacokinetic profile of the drug and an efficacy evaluation as measured by constraints such as the response rate by bone marrow biopsy.

Additionally, BL-8040 will also be evaluated for its capabilities in mobilising cancer cells from the bone marrow to the peripheral blood, and in inducing their cell death.

Partial results of the study are expected in the fourth quarter of 2013.