BioLineRx ( BLRX ) filed regulatory submissions with Hadassah Medical Center Institutional Review Board (IRB) for the commencement of a phase I study on BL-8040. The study will evaluate BL-8040 for the treatment of mobilization of stem cells from the bone marrow to the peripheral blood circulation. The study is likely to start in the second quarter of 2014. Preliminary results are expected in the second half of 2014.
The study is divided into two parts. The primary objective of the part I study is to explore the safety and tolerability of escalating repeated doses of BL-8040 in healthy volunteers. Assessment of the efficacy of BL-8040 in mobilizing stem cells as a stand-alone therapy, and also monitoring the pharmacokinetic profile of the drug constitute the secondary objectives of the study.
The primary objective of the part II study is to assess BL-8040's stem cell mobilization capacity, as well as the yield of cells collected by leukapheresis. Evaluation of the viability and biological activity of cells mobilized by BL-8040 and collected by leukapheresis will constitute the secondary objectives of this part of the study. Based on part I data, a dose regimen will be selected for the 8 patients in the part II single cohort study.
Meanwhile, BioLineRx is also studying BL-8040 in phase II for the treatment of adults suffering from relapsed/refractory acute myeloid leukemia (AML). BioLineRx expects results in the second half of 2014.
We remind investors that in Sep 2012, the rights to BL-8040 were in-licensed by BioLineRx from Biokine Therapeutics Ltd. BL-8040 received orphan drug designation for the treatment of AML from the U.S. Food and Drug Administration (FDA) in Sep 2013.
BioLineRx carries a Zacks Rank #3 (Hold). Better-ranked stocks include Lannett Company, Inc. ( LCI ), Actavis ( ACT ) and Endocyte, Inc. ( ECYT ). All the three stocks carry a Zacks Rank #1 (Strong Buy).
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
