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news.Israeli biopharmaceutical firm BioLineRx has started a Phase IIb trial for BL-8040 as a new consolidation treatment for patients with acute myeloid leukemia (AML).
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Conducted in collaboration with the University of Halle as sponsor and with the participation of two large leukemia study groups in Germany, the trial is aimed at evaluating the efficacy of BL-8040 in addition to standard consolidation therapy in these patients.
The double-blind, placebo-controlled, randomized, multi-center Phase IIb trial will enroll around 194 patients at about 25 sites in Germany.
The trial is designed to 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 reducing the minimal residual disease left in the bone marrow after induction therapy that can lead to relapse.
The Phase IIb trial is the first of three clinical studies in additional indications for BL-8040 which the company intends to commence during this year, thus significantly expanding its BL-8040 oncology platform.
BioLineRx chief executive officer Dr Kinneret Savitsky said: "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."
The company noted that based on the pre-clinical and clinical data accumulated to date, BL-8040 is expected to strengthen the efficacy of consolidation therapy due to its dual mechanism of action.
BL-8040 initially works by inducing mobilization of leukemic cells from the bone marrow, which improves the cytotoxic effects of chemotherapy, and secondly, it possesses anti-leukemic pro-apoptotic properties that help reduce AML cells directly.
The trial’s primary endpoint 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.
Additionally, pharmacodynamic measurements will be conducted to evaluate the minimal residual disease, and biomarker analyses will be performed to identify predictors of BL-8040 response.