Corporate Banner
Satellite Banner
Stem Cells, Cellular Therapy & Biobanking
>
Scientific Community
 
Become a Member | Sign in
Home>News>This Article
  News
Return

BioLineRx Receives Approval to Commence Phase 1 Trial for BL-8040

Published: Friday, June 20, 2014
Last Updated: Friday, June 20, 2014
Bookmark and Share
Phase 1 trial of BL-8040 expected to begin in Q3 2014.

BioLineRx Ltd. has announced that it has received approval from the Israeli Ministry of Health to commence a Phase 1 trial for BL-8040, a novel treatment for the mobilization of stem cells from the bone marrow to the peripheral blood circulation.

The study is expected to commence during the third quarter of 2014 at Hadassah Medical Center in Jerusalem.

Dr. Kinneret Savitsky, Chief Executive Officer of BioLineRx, stated, “Stem cell mobilization is being used more and more as a method of collecting stem cells, either for autologous use or for donation, instead of the surgical procedure of bone marrow harvesting. Current treatment regimens involve daily injections for 4-6 days of G-CSF, with or without the addition of a mobilizing agent such as Plerixafor (Mozobil). BL-8040 given as a single injection was previously shown in a Phase 1/2 study in multiple myeloma patients to be highly effective in mobilizing stem cells in combination with G-CSF injections. The current trial aims to evaluate the mobilization capacity of one or two injections of BL-8040 as a stand-alone therapy, which could significantly shorten and reduce treatment costs. In parallel, BL-8040 is undergoing a Phase 2 study for relapsed and refractory acute myeloid leukemia patients, the results of which are expected in early 2015. We also expect the commencement of an investigator-led Phase 1/2 study in chronic myeloid leukemia patients during 2014,” concluded Dr. Savitsky.

The Phase 1 study consists of two parts. Part 1 is a randomized, double-blind, placebo-controlled dose escalation study exploring the safety and tolerability of escalating repeated doses of BL-8040 in healthy volunteers.

Secondary objectives include assessment of the efficacy of BL-8040 in mobilizing stem cells as a stand-alone therapy, as well as determining the pharmacokinetic profile of the drug. This part will be performed in up to 4 cohorts, with 8 healthy volunteers in each cohort.

Part 1 of the study will serve to select the optimal safe and efficacious dose of BL-8040 to be used as a stand-alone therapy in Part 2 of the study.

Part 2 is an open-label study designed to assess BL-8040’s stem cell mobilization capacity, as well as the yield of cells collected by apheresis.

Secondary endpoints of the study include evaluation of the viability and biological activity of cells mobilized by BL-8040 and collected by apheresis.

This part will be performed in a single cohort of 8 healthy volunteers who will receive the selected dose regimen of BL-8040 based on the data from Part 1.


Further Information

Join For Free

Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 3,200+ scientific posters on ePosters
  • More than 4,600+ scientific videos on LabTube
  • 35 community eNewsletters


Sign In



Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into TechnologyNetworks.com you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.

Related Content

BioLineRx Presents Positive Safety and Efficacy Results for BL-8040
BL-8040’s rapid stem-cell mobilization supports stand-alone one-day treatment for stem-cell collection.
Tuesday, June 16, 2015
BioLineRx Reports Successful Top-Line Safety and Efficacy Results
BL-8040 Phase 1 study met all safety and efficacy endpoints.
Saturday, March 28, 2015
BioLineRx Completes Dose Escalation Stage of Phase 1 Trial for Stem Cell Mobilization
Results of Phase 1 trial for BL-8040 expected in Q1 2015.
Thursday, January 08, 2015
BioLineRx Announces Investigator-Initiated Study for Novel CML Treatment
Phase 1/2 study will assess effect of BL-8040 in combination with standard therapy.
Saturday, April 12, 2014
BioLineRx Announces Regulatory Submission for Novel Stem Cell Mobilization Treatment
Phase 1 trial of BL-8040 expected to begin in Q2 2014.
Monday, January 20, 2014
BioLineRx Reports Publication of Positive Phase 1/2 Results in Stem Cell Mobilization
Additional clinical trial in stem cell mobilization expected to commence in H1 2014.
Friday, November 22, 2013
Scientific News
Starving Stem Cells May Enable Scientists To Build Better Blood Vessels
Researchers from the University of Illinois at Chicago College of Medicine have uncovered how changes in metabolism of human embryonic stem cells help coax them to mature into specific cell types — and may improve their function in engineered organs or tissues.
Long-Term Culturing of Adult Stem Cells
A new procedure developed by Harvard Stem Cell Institute researchers (HSCI) at Massachusetts General Hospital (MGH) may revolutionize the culturing of adult stem cells.
Naked Mole Rat Exhibits “Extraordinary” Cancer Resistance
Scientists are getting closer to understanding the anti-cancer mechanism of the naked mole rat by making induced pluripotent stem cells.
Solutions for Biotherapeutic Characterization
Innovation to speed the routine.
Reclaiming The Immune System's Assault On Tumors
EPFL study shows a way to reclaim corrupted immune cells.
What Makes a Good Scientist?
It’s the journey, not just the destination that counts as a scientist when conducting research.
Body’s Own Gene Editing System Generates Leukemia Stem Cells
Inhibiting the editing enzyme may provide a new therapeutic approach for blood cancers.
Cirrhosis-Causing Cells Converted to Healthy Liver Cells in Mice
New approach that repairs liver from within may be more efficient than cell transplants.
A Boost for Regenerative Medicine
Growing tissues and organs in the lab for transplantation into patients could become easier after scientists discovered an effective way to produce three-dimensional networks of blood vessels, vital for tissue survival yet a current stumbling block in regenerative medicine.
Heart Defect Prediction Technology Could Lead to Earlier, More Informed Treatment
Experimental method uses genetics-guided biomechanics, patient-specific stem cells.
SELECTBIO

SELECTBIO Market Reports
Go to LabTube
Go to eposters
 
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
3,200+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,600+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!