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

BioLineRx Reports Publication of Positive Phase 1/2 Results in Stem Cell Mobilization

Published: Friday, November 22, 2013
Last Updated: Friday, November 22, 2013
Bookmark and Share
Additional clinical trial in stem cell mobilization expected to commence in H1 2014.

BioLineRx has announced the publication of results showing that BL-8040 (formerly known as BKT-140) enables the efficient mobilization of stem cells from the bone marrow into the peripheral blood, thus facilitating autologous stem cell transplantation in multiple myeloma patients. The research was published in the journal, Clinical Cancer Research.

High-dose chemotherapy followed by autologous stem cell transplantation has emerged as an established treatment modality for a variety of hematologic malignancies, including multiple myeloma, non-Hodgkin lymphoma and Hodgkin lymphoma.

Stem cells are mobilized from the bone marrow using granulocyte colony-stimulating factor (G-CSF), harvested from the peripheral blood by apheresis, and re-infused to the patient after chemotherapy. This type of treatment often replaces the more traditional use of bone marrow transplantation, because the stem cells are easier to collect and the treatment allows for a quicker recovery time and fewer complications.

In patients that do not respond well enough to G-CSF (up to 20% in multiple myeloma), treatment is often augmented by Plerixafor, a drug that inhibits CXCR4, a chemokine receptor that is important in hematopoietic stem cell homing to the bone marrow. However, even after the dual treatment, the mobilization of a sufficient number of stem cells remains a difficult objective in a sizeable proportion of patients.

BL-8040 is a novel, potent and selective inhibitor of the CXCR4 chemokine receptor. The results, obtained in 2011 and currently published in Clinical Cancer Research, show that BL-8040 binds with a very high affinity to CXCR4, and more importantly, it dissociates from the receptor in a very slow fashion.

As a result, BL-8040 has the unique ability, when compared to other CXCR4 inhibitors, to completely shut down the cell signaling process governing cell trafficking in the bone marrow. This exclusive activity of BL-8040 leads to a strong synergistic effect when combined with G-CSF, resulting in a rapid and robust stem cell mobilization therapy that is differentiated from the current standard of care.

This ability of BL-8040, which was originally demonstrated in animal studies, was confirmed in patients in a phase 1/2 non-randomized, open-label, dose escalation, multi-center study in multiple myeloma patients who underwent stem cell mobilization and collection for autologous stem cell transplantation.

Results of the clinical study show that BL-8040 was well tolerated at all concentrations, and that when combined with G-CSF, a single administration of BL-8040 at the highest dose (0.9 mg/kg) resulted in robust mobilization and collection of stem cells, which were then obtained through a single apheresis.

Furthermore, all transplanted patients rapidly engrafted. At the highest dose, the median times to neutrophil and platelet recovery were 12 and 14 days, respectively.

Dr. Kinneret Savitsky, Chief Executive Officer of BioLineRx, said, "We are very pleased with these promising results in stem cell mobilization, which are the basis for our decision to initiate an additional clinical trial for BL-8040 in this indication. In addition, we remain on track with BL-8040's on-going Phase 2 study for the treatment of relapsed and refractory acute myeloid leukemia patients, for which partial results are expected by the end of this year, with final results expected in the second half of 2014. Future development plans include additional clinical studies in stem cell mobilization and chronic myeloid leukemia, which are expected to commence during the first half of 2014."

Professor Arnon Nagler, Director of Hematology and Bone Marrow Transplantation Division at Sheba Medical Center, Israel and the lead principal investigator of the study, commented, "The use of peripheral blood as a source of hematopoietic stem cells for transplantation in cancer patients after high-dose chemotherapy has largely replaced traditional bone marrow transplantation. In order for this treatment to succeed, a sufficient amount of stem cells needs to be mobilized from the bone marrow into the blood stream, preferably in the first mobilization attempt and ideally with a minimum of apheresis sessions. BL-8040 offers a real solution for this need, enabling robust and reproducible stem cell mobilization in multiple myeloma patients."


Further Information
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 2,400+ scientific posters on ePosters
  • More than 3,700+ 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 Receives Approval to Commence Phase 1 Trial for BL-8040
Phase 1 trial of BL-8040 expected to begin in Q3 2014.
Friday, June 20, 2014
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
Scientific News
New Weapon in the Fight Against Blood Cancer
This strategy, which uses patients’ own immune cells, genetically engineered to target tumors, has shown significant success against multiple myeloma, a cancer of the plasma cells that is largely incurable.
Scientists Create CRISPR/Cas9 Knock-In Mutations in Human T Cells
In a project spearheaded by investigators at UC San Francisco, scientists have devised a new strategy to precisely modify human T cells using the genome-editing system known as CRISPR/Cas9.
Zebrafish Reveal Drugs that may Improve Bone Marrow Transplant
Compounds boost stem cell engraftment; could allow more matches for patients with cancer and blood diseases.
New Material Forges the Way for 'Stem Cell Factories'
Researchers have discovered the first fully synthetic substrate with potential to grow billions of stem cells. The researchcould forge the way for the creation of 'stem cell factories' - the mass production of human embryonic (pluripotent) stem cells.
Liver Regrown from Stem Cells
Scientists have repaired a damaged liver in a mouse by transplanting stem cells grown in the laboratory.
Immunotherapy Shows Promise for Myeloma
A strategy, which uses patients’ own immune cells, genetically engineered to target tumors, has shown significant success against multiple myeloma, a cancer of the plasma cells that is largely incurable.
'Google Maps' for the Body
Scientists have revealed research that uses previously top-secret technology to zoom through the human body down to the level of a single cell that could be a game-changer for medicine.
Adaptimmune's Novel Cancer Therapeutics Show Positive Clinical Trial Results
The company has announced that positive data from its Phase I/II study of its affinity enhanced T-cell receptor (TCR) therapeutic targeting the NY-ESO-1 cancer antigen in patients with multiple myeloma has been published.
Stem Cells Rescue Patients from Mitochondrial Disease
A study led by OHSU researchers has revealed a critical first step in developing a new gene and stem cell regenerative technique for treating patients with mitochondrial disease.
Eco-Friendly Nanobullet to Battle Bacteria
Researchers have developed a method to combat bacteria by engineering nanoscale particles that add the antimicrobial potency of silver to a core of lignin, a ubiquitous substance found in all plant cells.
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
2,400+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
3,700+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FREE!