Regulatory Submission for Phase 2b Trial for Novel AML Consolidation Treatment
News Mar 03, 2015
BioLineRx Ltd. has announced the filing of regulatory submissions required to commence a Phase 2b trial for BL-8040 as a novel consolidation treatment for acute myeloid leukemia (AML).
Due to BL-8040’s unique properties, the Phase 2b study will examine its ability to improve outcomes for AML patients who have achieved remission after standard treatment by eliminating the minimal residual disease left in the bone marrow that can lead to relapse, known as consolidation therapy.
The study is expected to commence shortly after the receipt of regulatory approval, which is anticipated in the next few months, and is the first of three additional planned clinical studies that significantly expand BioLineRx’s unique BL-8040 platform for treating hematological cancers.
The Phase 2b trial is a double-blind, placebo-controlled, randomized, multi-center study conducted in collaboration with the University of Halle as sponsor and with the participation of two large leukemia study groups in Germany.
Regulatory submissions with BfArM, the German Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte) and the relevant ethics committees have been made.
Dr. Kinneret Savitsky, Chief Executive Officer of BioLineRx, stated, “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 2a 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.”
“Furthermore, BL-8040 has several unique mechanisms of action that enable it to positively affect various aspects of bone marrow function, both relating to healthy stem cells as well as to cancer cells. The breadth of BL-8040’s potential is reflected in the comprehensive development plan we have established for this compound. We look forward to initiating this Phase 2b trial as well as our other planned studies for 2015, and to advancing this promising treatment platform for multiple hematological indications,” concluded Dr. Savitsky.
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