Advertisement BioLineRx seeks German approval to begin Phase IIb trial of leukemia drug candidate BL-8040 - Pharmaceutical Business review
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BioLineRx seeks German approval to begin Phase IIb trial of leukemia drug candidate BL-8040

Israeli biopharmaceutical firm BioLineRx has submitted regulatory applications to the German Federal Institute for Drugs and Medical Devices (BfArM) seeking approval to begin a Phase IIb trial of its clinical-stage drug candidate BL-8040 as a new consolidation treatment for acute myeloid leukemia (AML).

BL-8040, which is designed to treat acute myeloid leukemia, as well as other hematological indications, mobilizes cancer cells from the bone marrow and may therefore sensitize these cells to chemo- and bio-based anti-cancer therapy.

BioLineRx chief executive officer Kinneret Savitsky said: "Without consolidation treatment aimed at destroying the remaining leukemic cells, AML is likely to return within several months of initial remission.

"The current principal options for AML consolidation therapy involve either several cycles of high-dose chemotherapy or stem cell transplantation.

"Based on positive results from our ongoing phase IIa clinical trial for BL-8040, which show substantial mobilization of AML cancer cells from the bone marrow to the peripheral blood, as well as induction of apoptosis of AML cells, we believe BL-8040 will be a promising addition to consolidation therapy for AML patients."

The trial is designed to examine BL-8040’s ability to improve outcomes for AML patients who have achieved remission after standard treatment by reducing the minimal residual disease left in the bone marrow that can lead to relapse, known as consolidation therapy.

After securing regulatory approval, the company will start the Phase II trial, which is the first of three additional planned clinical studies that significantly expand the company’s BL-8040 platform for treating hematological cancers.

The double-blind, placebo-controlled, randomized, multi-center Phase IIb trial will be carried out in collaboration with the University of Halle as sponsor and with the participation of two large leukemia study groups in Germany.