7:04AM BioLineRx reports promising initial Phase 2 results of acute myeloid leukemia treatment; initial results for BL-8040 show substantial mobilization of cancer cells and signs of robust cancer cell death (BLRX) 2.55 : Co announces promising initial results for its BL-8040 drug candidate in a Phase 2 clinical trial for patients with relapsed or refractory acute myeloid leukemia. The early results show that BL-8040, as a stand-alone therapy and in combination with high-dose Cytarabine, is safe at all doses tested to date, and triggers substantial mobilization of cancer cells from the bone marrow to the peripheral blood, thereby increasing the vulnerability of the cells to chemotherapy treatment. In addition, signs of robust apoptosis of cancer cells were observed following administration of the higher doses tested to date. The study has not yet reached the highest planned doses, suggesting that a strengthening of BL-8040's effects may be observed in future dosing cohorts.
The Phase 2 trial is a multicenter, open-label study under an IND, and is designed to evaluate the safety and efficacy of repeated escalating doses of BL-8040 in adult patients with relapsed or refractory AML. The primary endpoints of the study are to assess the safety and tolerability of BL-8040. Secondary endpoints include the pharmacokinetic profile of the drug and an efficacy evaluation, indicated by the extent of mobilization of cancer cells from the bone marrow to the peripheral blood, the level of cancer cell death (apoptosis) and clinical responses.
Eight patients have already been enrolled in the study, out of a total expected enrollment of up to 50 patients at eight clinical sites in the U.S. and Israel. To date, there have been no serious adverse events related to BL-8040, while the primary adverse event has been a minor and transient reaction at the injection site. The BL-8040 dosing level of the current study cohort is 1 mg/kg, with the highest planned study dose being 1.5 mg/kg.
Market Data 
Markets 
AI
