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

BioLineRx Enrolls First Patient in Phase 2 Clinical Trial for BL-8040

Published: Friday, June 07, 2013
Last Updated: Friday, June 07, 2013
Bookmark and Share
Partial results expected in Q4 2013.

BioLineRx has announced enrollment of the first patient in a Phase 2 trial for BL-8040, for the treatment of acute myeloid leukemia (AML).

The patient was enrolled at the MD Anderson Cancer Center in Houston, Texas. The Company also announced that, in addition to receiving regulatory approval for commencing the trial in the U.S. this past April, it has also recently received regulatory approval from the Israeli Ministry of Health to conduct the trial in Israel. The activation of Israeli sites is anticipated during the next few weeks.

The study is a multicenter, open-label study under an IND, designed to evaluate the safety and efficacy profile of repeated escalating doses of BL-8040 in adult subjects with relapsed or refractory AML.

The primary endpoints of the study are the safety and tolerability of BL-8040. Secondary endpoints include the pharmacokinetic profile of the drug and an efficacy evaluation, as assessed by various parameters, such as the response rate by bone marrow biopsy.

The study is also designed in a way that will enable the investigators to evaluate the capabilities of BL-8040 in mobilizing cancer cells from the bone marrow to the peripheral blood, and in inducing their cell death.

Up to 50 patients are expected to be enrolled in the study, which is expected to be conducted at 8 sites in the U.S. and Israel.

“We are very excited that BL-8040's Phase 2 trial has begun at a world-leading cancer research center such as MD Anderson,” said Kinneret Savitsky, Ph.D., CEO of BioLineRx.

Savitsky continued, "We anticipate that additional world-leading cancer research centers in the U.S. will join MD Anderson in this promising Phase 2 trial. In addition, the recently received regulatory approval from the Israeli Ministry of Health will also expedite recruitment of patients at several leading sites in Israel.”

“The development of novel drugs for AML is critical, since treatment options for this common type of leukemia are still limited compared to other leukemia types. This is particularly apparent with respect to patients with relapsed or refractory diseases. Considering the compound’s unique biological pathway and its promising pre-clinical results, BioLineRx and its clinical partners are enthusiastic about BL-8040. We have high hopes for BL-8040 and look forward to the partial results expected towards the end of this year,” concluded Dr. Savitsky.


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 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
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 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
BioLineRx Presents Positive Preclinical Results in Treatment for AML Patients
Results in this additional indication for BL-8040 presented at Society of Hematologic Oncology Annual Meeting.
Saturday, September 20, 2014
BioLineRx Doses First Patient for BL-8040’s Second Indication
Results from Phase 1 trial expected by end of 2014 or early 2015.
Friday, September 05, 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 Positive Preclinical Results for Novel Treatment for CML
BL-8040 study published in Molecular Cancer Therapeutics.
Thursday, February 13, 2014
BioLineRx Announces Promising Initial Phase 2 Results of AML Treatment
Initial results for BL-8040 show substantial mobilization of cancer cells and signs of robust cancer cell death (apoptosis).
Friday, December 20, 2013
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
BioLineRx Announces Publication of Positive Pre-Clinical Results for BL-8040
Results published in the British Journal of Hematology.
Thursday, August 08, 2013
BioLineRx Receives Regulatory Approval to Commence Phase II Clinical Trial for BL-8040
Final results expected in H2 2014.
Thursday, April 11, 2013
BioLineRx In-Licenses BL-8040 for the Treatment of AML
Phase II clinical trials are expected to commence in H1 2013.
Wednesday, January 16, 2013
Scientific News
Poor Survival Rates in Leukemia Linked to Persistent Genetic Mutations
For patients with an often-deadly form of leukemia, new research suggests that lingering cancer-related mutations – detected after initial treatment with chemotherapy – are associated with an increased risk of relapse and poor survival.
Searching Big Data Faster
Theoretical analysis could expand applications of accelerated searching in biology, other fields.
Growing Hepatitis C in the Lab
Recent discovery allows study of naturally occurring forms of hepatitis C virus (HCV) in the lab.
Inciting an Immune Attack on Cancer Cells
A new minimally invasive vaccine that combines cancer cells and immune-enhancing factors could be used clinically to launch a destructive attack on tumors.
Reprogramming Cancer Cells
Researchers on Mayo Clinic’s Florida campus have discovered a way to potentially reprogram cancer cells back to normalcy.
Genetic Overlapping in Multiple Autoimmune Diseases May Suggest Common Therapies
CHOP genomics expert leads analysis of genetic architecture, with eye on repurposing existing drugs.
Surprising Mechanism Behind Antibiotic-Resistant Bacteria Uncovered
Now, scientists at TSRI have discovered that the important human pathogen Staphylococcus aureus, develops resistance to this drug by “switching on” a previously uncharacterized set of genes.
How DNA ‘Proofreader’ Proteins Pick and Edit Their Reading Material
Researchers from North Carolina State University and the University of North Carolina at Chapel Hill have discovered how two important proofreader proteins know where to look for errors during DNA replication and how they work together to signal the body’s repair mechanism.
Fat in the Family?
Study could lead to therapeutics that boost metabolism.
Tissue Bank Pays Dividends for Brain Cancer Research
Checking what’s in the bank – the Brisbane Breast Bank, that is – has paid dividends for UQ cancer researchers.
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
2,500+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
3,700+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FREE!