BioLineRx Reports Early Phase 2 Results For Its BL-8040 - Quick Facts

(RTTNews) - Biopharmaceutical development company BioLineRx (BLRX), Monday announced initial results for its BL-8040 drug candidate in a Phase 2 study for patients with relapsed or refractory acute myeloid leukemia or AML, that indicated the drug, 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. Additionally, signs of robust apoptosis of cancer cells were noted. The trial has however not reached the highest planned doses.

The primary endpoints of the Phase 2 study are to assess the safety and tolerability of BL-8040, while the 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 and clinical responses. The study is comprised of two parts; the current dose escalation phase and a subsequent expansion phase at the highest tolerated dose found during the escalation phase.

Kinneret Savitsky, Chief Executive Officer commented: "We are looking forward to reporting further interim results at the end of the dose escalation phase, expected during the second quarter of 2014, with final study results expected in the second half of 2014. Future development plans for BL-8040 include entering into additional hematological indications, including the commencement of clinical studies in stem cell mobilization and chronic myeloid leukemia during the first half of 2014."