Biopharmaceutical development company BioLineRx has enrolled the first patient in a Phase II trial of acute myeloid leukaemia (AML) drug BL-8040.
Scheduled to be conducted at eight sites in the US and Israel, the enrolment follows the receipt of regulatory approvals from the US Food and Drug Administration (FDA) and the Israeli Ministry of Health to begin the trial.
The first patient was enrolled at the MD Anderson Cancer Center in Houston, Texas.
BioLineRx CEO Dr Kinneret Savitsky said; "We anticipate that additional world-leading cancer research centers in the US will join MD Anderson in this promising Phase II trial.
"Considering the compound’s unique biological pathway and its promising pre-clinical results, BioLineRx and its clinical partners are enthusiastic about BL-8040."
Recruitment of patients in Israel will be accelerated after the activation of the sites, which is expected to take place in the next few weeks.
Designed to assess the safety and efficacy profile of repeated escalating doses of BL-8040, the multicentre, open-label study will enrol 50 adult patients with relapsed or refractory AML.
Drug safety and tolerability are the primary endpoints, while the secondary endpoints include pharmacokinetic profile of the drug and an efficacy evaluation as measured by constraints such as the response rate by bone marrow biopsy.
With partial results expected in the fourth quarter of 2013, the study will enable the evaluation of BL-8040’s capabilty to mobilising cancer cells from the bone marrow to the peripheral blood, and induce their cell death.
Image: Bone marrow aspirate showing acute myeloid leukemia. Arrows indicate Auer rods. Photo: Courtesy of VashiDonsk.