Corporate Banner
Satellite Banner
Technology
Networks
Scientific Communities
 
Become a Member | Sign in
Home>News>This Article
  News
Return

BioLineRx Announces Regulatory Submission for Novel Stem Cell Mobilization Treatment

Published: Monday, January 20, 2014
Last Updated: Monday, January 20, 2014
Bookmark and Share
Phase 1 trial of BL-8040 expected to begin in Q2 2014.

BioLineRx has announced that it has filed the necessary regulatory submissions 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 regulatory submissions were filed with the Hadassah Medical Center Institutional Review Board (IRB), and the study is expected to commence during the second quarter of 2014.

The Phase 1 study will be divided into 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 monitoring 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 leukapheresis. Secondary endpoints of the study include evaluation of the viability and biological activity of cells mobilized by BL-8040 and collected by leukapheresis. 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.

"Increasingly, stem cell mobilization is being used as a method of collecting stem cells, either for autologous use or for donation, instead of the surgical procedure of bone marrow harvesting. The current procedure involves daily injections of G-CSF for 4-6 days, a procedure that is costly, and moreover, not effective in up to 20% of multiple myeloma patients. Therefore, we were very enthusiastic about the results of BL-8040's Phase 1/2 study in multiple myeloma patients, recently published in the peer review journal Clinical Cancer Research, which showed that a single injection of BL-8040 is highly effective in mobilizing stem cells in combination with G-CSF," explained Dr. Kinneret Savitsky, Chief Executive Officer of BioLineRx.

Dr. Savitsky continued, "This trial now aims to assess the mobilization efficacy of BL-8040 as a stand-alone therapy, which could shorten and reduce costs of the mobilization protocol significantly. As previously announced, BL-8040 is also currently in the midst of a Phase 2 study for acute myeloid leukemia patients, the results of which are expected in the second half of 2014. Stem cell mobilization is just one example of the additional hematological indications that we intend to investigate for the BL-8040 platform in the future."


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 2,900+ scientific posters on ePosters
  • More Than 4,200+ 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 Announces Collaboration with MSD
Collaboration to investigate the combination of KEYTRUDA (pembrolizumab) and BL-8040 in pancreatic cancer.
Wednesday, January 13, 2016
BioLineRx Announces Regulatory Submission for Phase 2 Trial of BL-8040
Study will be conducted in collaboration with Washington University School of Medicine, Division of Hematology and Oncology.
Thursday, December 17, 2015
BioLineRx Announces Initiation of Phase 1/2 Trial for BL-8040
Interim results of study, in patients with hypoplastic myelodysplastic syndrome (hMDS) and aplastic anemia (AA), expected by end of 2016.
Thursday, November 26, 2015
BioLineRx Announces Positive Results from First Part of Phase 2 Trial in r/r AML
Data strongly suggest BL-8040 has potent anti-leukemic activity in combination with Ara-C in AML.
Saturday, November 07, 2015
BioLineRx’s BL-5010 Submitted for CE Mark Registration
Product expected to reach the market in 2016.
Friday, September 11, 2015
BioLineRx Announces Regulatory Submission for Phase 2 Trial of BL-8040
Study collaboration with MD Anderson Cancer Center will assess BL-8040 as combination treatment with immunosuppressants.
Friday, September 11, 2015
BioLineRx Reports Second Quarter 2015 Financial Results
Company to initiate a pivotal CE Mark registration study for BL-7010 in the fourth quarter of 2015.
Saturday, August 22, 2015
BioLineRx Announces Initiation of Phase 2b Trial for Novel AML Consolidation Treatment
Study is first of three additional clinical studies for BL-8040 platform expected to commence during 2015.
Tuesday, August 18, 2015
Top-Line Results from Bellerophon’s PRESERVATION I Clinical Trial for BCM
An investigational, implantable medical device being studied for the prevention of heart failure following an AMI.
Wednesday, August 05, 2015
BioLineRx to Present Successful Results of Phase 1/2 Study for BL-7010
Company will present results at the 16th International Celiac Disease Symposium (ICDS 2015).
Friday, June 19, 2015
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
Research Underlying BL-9020 Wins Hebrew University's Kaye Innovation Award
BL-9020, a novel monoclonal antibody for the treatment of Type 1 diabetes.
Saturday, June 13, 2015
BioLineRx Announces Publication of BL-5010 Phase 1/2 Trial Results
Previously reported results published in British Journal of Dermatology.
Thursday, June 04, 2015
BioLineRx Initiates Expansion Stage of Phase 2 Clinical Trial for AML Treatment
Top-line results expected Q4 2015.
Tuesday, May 05, 2015
BioLineRx Reports Year End 2014 Financial Results
Top-line results from Phase 2a clinical study of BL-8040 expected in the second half of 2015.
Tuesday, March 31, 2015
Scientific News
Natural Protein Points to New Inflammation Treatment
Findings may offer insight to effective treatments for inflammatory diseases, such as rheumatoid arthritis, psoriasis, and multiple sclerosis.
Genetic Cause of Rare Allergy
Institute has identified a genetic mutation responsible for a rare form of inherited hives induced by vibratory urticaria.
Battery Component Found to Harm Key Soil Microorganism
The material at the heart of the lithium ion batteries that power electric vehicles, laptop computers and smartphones has been shown to impair a key soil bacterium, according to new research.
Keeping Tumor Growth at Bay
Engineers at Washington University in St. Louis found a way to keep a cancerous tumor from growing by using nanoparticles of the main ingredient in common antacid tablets.
Natural Protein Points to New Inflammation Treatment
Findings may offer insight to effective treatments for inflammatory diseases, such as rheumatoid arthritis, psoriasis, and multiple sclerosis.
Mitochondria Shown to Trigger Cell Ageing
An international team of scientists has for the first time shown that mitochondria, the batteries of the cells, are essential for ageing.
Cancer Cells Kill Off Healthy Neighbours
Cancer cells create space to grow by killing off surrounding healthy cells, according to UK researchers working with fruit flies.
Validating the Accuracy of CRISPR-Cas9
IBS Researchers create multiplex Digenome-seq to find errors in CRISPR-Cas9 processes.
Cancer Drug Target Visualized at Atomic Resolution
New study using cryo-electron microscopy shows how potential drugs could inhibit cancer.
Genetic Mechanism Behind Cancer-Causing Mutations
Researchers at Indiana University has identified a genetic mechanism that is likely to drive mutations that can lead to cancer.
Scroll Up
Scroll Down
Skyscraper Banner

Skyscraper Banner
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
2,900+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,200+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!