BioLineRx Ltd. has announced the initiation of a Phase 2b trial for BL-8040 as a novel consolidation treatment for acute myeloid leukemia (AML). The Phase 2b study will examine BL-8040 as part of a second stage treatment, termed consolidation therapy, to improve outcomes for AML patients who have achieved remission after the standard initial treatment regimen, known as induction therapy.
The consolidation therapy is aimed at eliminating the minimal residual disease left in the bone marrow after induction therapy that can lead to relapse. This study is the first of three clinical studies in additional indications for BL-8040 which BioLineRx plans to commence during 2015, thus significantly expanding its unique BL-8040 oncology platform.
Dr. Kinneret Savitsky, Chief Executive Officer of BioLineRx, stated, “The majority of high-risk AML patients achieving first complete remission relapse within one year, despite the current standard consolidation therapy. Patients with AML relapse have a poor prognosis despite further therapy, and less than 10% of these patients are cured by conventional therapy. Leukemic stem cells that are dormant in the bone marrow are presumed to be a major reason for AML relapse. Based on the pre-clinical and clinical data accumulated to date, BL-8040 is anticipated to boost the efficacy of consolidation therapy due to its dual mechanism of action. Firstly, BL-8040 induces mobilization of leukemic cells from the bone marrow, which enhances the cytotoxic effects of chemotherapy, and secondly, it possesses anti-leukemic pro-apoptotic properties that help eliminate AML cells directly. Based on positive results from our ongoing phase 2 clinical trial for BL-8040, which show substantial mobilization of AML cells from the bone marrow to the peripheral blood, as well as robust induction of AML cell apoptosis, we believe BL-8040 will be a promising addition to consolidation therapy for AML patients.”
Dr. Savitsky added, “In addition to initiation of the Phase 2b AML consolidation study, we are eagerly looking forward to the top-line results from our ongoing Phase 2 study of BL-8040 for treating relapsed and refractory AML patients, which we expect in the fourth quarter of 2015. We also look forward to the next stages of development for BL-8040 as a novel stem cell mobilization treatment, after its recent successful completion of a Phase 1 trial. Finally, we are also excited about the anticipated initiation of clinical studies for BL-8040 in two additional indications over the next few months, thus further expanding and enhancing the potential of our oncology platform.”
The Phase 2b trial, which is conducted in collaboration with the University of Halle as sponsor and with the participation of two large leukemia study groups in Germany, is a double-blind, placebo-controlled, randomized, multi-center study aimed at assessing the efficacy of BL-8040 in addition to standard consolidation therapy in AML patients. The primary endpoint of the study is to compare the relapse free survival (RFS) time in AML subjects in their first remission during a minimum follow-up time of 18 months after randomization.
In addition, pharmacodynamic measurements will be conducted in order to assess the minimal residual disease, and biomarker analyses will be performed to identify predictors of BL-8040 response.
The study will enroll up to 194 patients at up to 25 sites in Germany. AML patients between 18 and 75 years of age with documented first remission will be randomized in a 1:1 ratio to receive high dose Cytarabine, either with BL-8040 or with a matching placebo, as consolidation therapy.