Blog Exposure – BioLine Declares Initiation of Phase-3 GENESIS Trial in Stem-Cell Mobilization Therapy BL-8040

LONDON, UK / ACCESSWIRE / December 26, 2017 / Active-Investors.com has just released a free research report on BioLine Rx Ltd (NASDAQ: BLRX) (“BioLineRx”). If you want access to this report all you need to do is sign up now by clicking the following link www.active-investors.com/registration-sg/?symbol=BLRX as the Company’s latest news hit the wire. On December 21, 2017, the Company, a clinical-stage biopharmaceutical Company focused on oncology and immunology, announced that it has initiated its Phase-3 GENESIS clinical trial, wherein its stem cell mobilization asset, BL-8040, will be compared to placebo, on top of granulocyte colony-stimulating factor (G-CSF), for the mobilization of hematopoietic stem cells (HSCs) used for autologous transplantation in multiple myeloma patients. Register today and get access to over 1000 Free Research Reports by joining our site below:

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Active-Investors.com is focused on giving you timely information and the inside line on companies that matter to you. This morning, BioLine Rx most recent news is on our radar and our team decided to put out a fantastic report on the company that is now available for free below:

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About BL-8040

BL-8040 is the main therapeutic candidate of BioLineRx. It is a short peptide for the treatment of stem cell mobilization, acute myeloid leukemia, and solid tumors. It has shown strong stem-cell mobilization, including the mobilization of colony-forming cells T, B, and NK cells. BL-8040 functions as a high-affinity antagonist for CXCR4, with long receptor occupancy. Mostly, CXCR4 gets over-expressed in over 70% of human cancers and its expression intensifies the disease severity.
BioLineRx has successfully completed the Phase-2a study of BL-8040 for treating relapsed/refractory Acute Myeloid Leukemia (AML). The Company is also in the middle of a Phase-2b study as an AML consolidation treatment, and has initiated a Phase-3 study in stem cell mobilization for autologous transplantation.
In its clinical and pre-clinical studies, BL-8040 has demonstrated vigorous mobilization of cancer cells and immune-cells from the bone marrow, which in turn, sensitives cancer cells to chemo- and bio-based anti-cancer therapy, and directs anti-cancer effect by inducing cell death (apoptosis) and mobilizing immune-cells.
BioLineRx from Biokine Therapeutics had licensed BL-8040, which was previously sold under the name BKT-140.

Phase-3 Study Design

The Phase-3 study, which has been named the GENESIS study, is a randomized, placebo-controlled, multicenter study, that aims to evaluate the safety, tolerability, and efficacy of BL-8040 and G-CSF compared to placebo and G-CSF, for the mobilization of HSCs for autologous transplantation in multiple myeloma patients.
The study will start with a lead-in period for dose confirmation with about 10 to 30 patients. Post that, it will proceed to the placebo-controlled main part, which will cover a total of 177 patients in over 15 centers.
The treatment will include about 5-8 days of G-CSF, with a single dose of BL-8040 or placebo on day 4. The apheresis for stem cell collection will be performed on the fifth day while more apheresis sessions would be conducted if needed in order to reach the benchmark of ≥ 6×106 mobilized HSCs.

Primary and Secondary Objectives

The primary objective of the study is to validate that BL-8040, on top of G-CSF, is greater than G-CSF alone in the ability of mobilizing ≥ 6×106 HSCs in up to 2 aphereses. The secondary objective comprise time to engraftment of neutrophils and platelets, and durability of engraftment, as well as other efficacy and safety parameters.

An Important Development in the Field of Oncology

The commencement of the Phase-3 trial for BL-8040 is a significant milestone in the development of BioLineRx’s lead oncology platform. Treatment with BL-8040 as a single administration and up-to-two-day collection regimen for rapid mobilization of stem cells would lead to a significant improvement from the existing treatment, which requires up to four apheresis sessions. The top-line results from the Phase-3 study are expected in 2020.

Dr. John F. DiPersio, Chief, Division of Oncology at the Washington University School of Medicine, is serving as the lead investigator for the study. He is thrilled to evaluate the role of BL-8040, which is a novel CXCR4 inhibitor with G-CSF for the mobilization of peripheral blood stem cells from patients undergoing autologous transplant for multiple myeloma. He expects that this would give way to another approach for the optimal hematopoietic stem cell collection in this challenging group of patients.

Stock Performance Snapshot

December 22, 2017 – At Friday’s closing bell, BioLine Rx’s stock rose 1.79%, ending the trading session at $1.14.

Volume traded for the day: 417.41 thousand shares.

Stock performance in the last month – up 10.68%; previous six-month period – up 32.56%; past twelve-month period – up 16.33%; and year-to-date – up 23.91%

After last Friday’s close, BioLine Rx’s market cap was at $118.69 million.

The stock is part of the Healthcare sector, categorized under the Biotechnology industry.

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