Corporate Banner
Satellite Banner
Pharma Outsourcing
Scientific Community
 
Become a Member | Sign in
Home>News>This Article
  News
Return

BioLineRx In-Licenses BL-8040 for the Treatment of AML

Published: Wednesday, January 16, 2013
Last Updated: Tuesday, January 15, 2013
Bookmark and Share
Phase II clinical trials are expected to commence in H1 2013.

BioLineRx Ltd. has announced that it has signed an exclusive, worldwide license agreement with Biokine Therapeutics Ltd., a Clal Biotechnology Industries portfolio company, for the development and commercialization of BL-8040 (formerly BKT-140), a Phase II ready drug candidate for the treatment of acute myeloid leukemia (AML), as well as other types of hematological cancer.

BL-8040 is a short peptide that functions as a high-affinity antagonist for CXCR4, a chemokine receptor that is directly involved in tumor progression, angiogenesis (growth of new blood vessels in the tumor), metastasis (spread of the disease to other organs or organ parts) and cell survival.

CXCR4 is over-expressed in more than 70% of human cancers and its expression often correlates with disease severity.

In a Phase I/II, open-label, dose escalation, safety and efficacy clinical trial in 16 multiple myeloma patients, BL-8040 demonstrated an excellent safety profile and was well tolerated at all doses tested.

On the basis of data obtained from this study, the FDA has approved an IND application.

BL-8040 has been shown to induce the mobilization of healthy hematopoietic stem cells from the bone marrow into the peripheral blood.

BL-8040 also mobilizes cancer cells from the bone marrow and other sites and may therefore expose these cells to chemo- and bio-based anti-cancer therapy and induce apoptosis (cell death).

Pre-clinical studies show that BL-8040 is efficient, both alone and in combination with the anti-cancer drug Rituximab, in reducing bone marrow metastasis of lymphoma cells and stimulating lymphoma cell death.

Dr. Kinneret Savitsky, CEO of BioLineRx, commented, "BioLineRx has made a strategic decision to enter the field of oncology, where there is clearly an urgent need for next generation anti-cancer therapies utilizing novel biological pathways. We are therefore extremely pleased to in-license this promising Phase II ready drug, which we will initially develop for the treatment of acute myeloid leukemia, a true unmet medical need with very low survival rates. AML is a recognized orphan indication both in the U.S. and the EU; therefore, we plan to seek orphan designation status from the regulatory authorities in order to accelerate its development plan. In addition, based on BL-8040’s promising pre-clinical data, as well its mechanism of action, we believe it can be utilized for several other related oncology indications and we intend to explore these possibilities as well. We look forward to the upcoming Phase II clinical study for evaluating BL-8040’s efficacy on AML patients, which is expected to commence in the first half of 2013."

"We are very happy that BioLineRx will further develop this promising anti-cancer agent, and are confident that BioLineRx’s experience and expertise will advance BL-8040 through the clinical development stages in the most efficient manner,” said Professor Amnon Peled, from the Gene Therapy Institute, Hadassah Medical Center - Jerusalem, founder and CEO of Biokine Therapeutics.

“CXCR4 is one of the most important cancer targets discovered in recent years. It is essential for multiple aspects of cancer progression in over 70% of all cancers, including leukemia, breast, lung, colon, and prostate cancer. BL-8040, as a CXCR4 antagonist, therefore has the potential to target and kill various cancer cells, and studies in animal models of the disease have shown that this agent may stimulate hematological cancer cell death. In addition, for many blood cancers, the bone marrow provides protection for malignant cells from chemotherapeutic agents. Therefore, by inducing mobilization of these cells into the peripheral blood, CXCR4 antagonists literally ‘flush out’ the malignant cells from their hiding places.

“We have demonstrated in pre-clinical studies that BL-8040 is very effective in mobilizing cells out of the bone marrow, thus sensitizing chemo-resistant cells and improving treatment with other anti-cancer drugs," concluded Professor Peled.


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 2,500+ 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 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
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
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’s Treatment for Type 1 Diabetes Effective in Preclinical Trials
Results of experiments with BL-9020, a new antibody treatment, published in PLoS One.
Friday, March 13, 2015
Regulatory Submission for Phase 2b Trial for Novel AML Consolidation Treatment
BL-8040 Phase 2b study, as consolidation treatment for AML patients responding to standard induction treatment, is expected to commence shortly after receipt of regulatory approval, anticipated in next few months.
Tuesday, March 03, 2015
BioLineRx Announces Completion of Enrollment in CE Mark Registration Trial of BCM
PRESERVATION I trial completion anticipated in mid-2015.
Thursday, January 15, 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 Out-Licenses Novel Skin Lesion Treatment to Omega Pharma
First product expected to reach the market in 2016.
Friday, December 26, 2014
BioLineRx Presents Multi-Year Clinical Development Plan for BL-8040
Clinical trials in three additional indications for BL-8040 to be initiated in 2015.
Saturday, December 13, 2014
Scientific News
NIH Study Shows No Benefit of Omega-3 Supplements for Cognitive Decline
Research was published in the Journal of the American Medical Association.
NIH Launches Human RSV Study
Study aims to understand infection in healthy adults to aid development of RSV medicines, vaccines.
Computerized Flexible Needles Prove Themselves in Biological Tissue
The advantage of the system is that you can avoid obstacles with the needles or critical tissues and that the system during the insertion of the needle in real time can adjust the path if, for example, the tissue deforms.
DARWIN 2 24-week Monotherapy Data in RA Confirm Previous Results
Safety profile in DARWIN 2 consistent with previous filgotinib RA studies.
Researchers Publish Landmark “Basket Study”
Researchers from Memorial Sloan Kettering Cancer Center (MSK) have announced results from the first published basket study, a new form of clinical trial design that explores responses to drugs based on the specific mutations in patients’ tumors rather than where their cancer originated.
Agricultural Intervention Improves HIV Outcomes
A multifaceted farming intervention can reduce food insecurity while improving HIV outcomes in patients in Kenya, according to a randomized, controlled trial led by researchers at UC San Francisco.
Overdose of Vitamin D in Teenagers May Lead to Increased Cholesterol Levels
Dosing obese teens with vitamin D shows no benefits for their heart health or diabetes risk, and could have the unintended consequences of increasing cholesterol and fat-storing triglycerides. These are the latest findings in a series of Mayo Clinic studies in childhood obesity.
Phase 2 Trials Underway for New Single Dose Malaria Treatment
The new drug, which prevents the malaria parasite from reproducing and spreading, is now undergoing Phase II clinical trials in humans.
Promising Drug for Parkinson's Disease
A drug which has already been in use for decades to treat liver disease could be an effective treatment to slow down progression of Parkinson’s disease, scientists from the University of Sheffield have discovered.
Benefits of Early Antiretroviral Therapy in HIV Infection
Scientists have explored the clinical importance of starting treatment early in individuals suffering with HIV.
Scroll Up
Scroll Down
SELECTBIO

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
2,500+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
3,700+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FREE!