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

BioLineRx's BL-8040 Receives Orphan Drug Designation for Treatment of AML

Published: Tuesday, September 10, 2013
Last Updated: Tuesday, September 10, 2013
Bookmark and Share
BL-8040's Phase 2 study results expected towards the end of 2013.

BioLineRx has announced that the U.S. Food & Drug Administration (FDA) has granted an Orphan Drug Designation to BL-8040 as a therapeutic for the treatment of acute myeloid leukemia (AML).

Orphan Drug Designation is granted to therapeutics intended to treat rare diseases that affect not more than 200,000 people in the United States.

Orphan Drug Designation entitles the sponsor to a seven-year market exclusivity period, clinical protocol assistance with the FDA, as well as federal grants and tax credits.

"We are very pleased to have received Orphan Drug Designation for BL-8040, which will facilitate the development process of one of our key clinical stage assets," stated Dr. Kinneret Savitsky, Chief Executive Officer of BioLineRx.

"Currently, AML treatment options, especially in patients with a relapse of the disease, are extremely limited. BL-8040 has the potential to be a significant addition to the drug arsenal for this disease, especially when considering its promising pre-clinical results, unique biological mechanism and ability to synergize with other drugs already approved for this disease. Therefore, we are eagerly looking forward to the partial results of BL-8040's Phase 2 study expected towards the end of 2013," 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 2,800+ scientific posters on ePosters
  • More Than 4,000+ 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 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 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
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
Scientific News
High Throughput Mass Spectrometry-Based Screening Assay Trends
Dr John Comley provides an insight into HT MS-based screening with a focus on future user requirements and preferences.
New Analysis Technique for Chiral Activity in Molecules
Professor Hyunwoo Kim of the Chemistry Department and his research team have developed a technique that can easily analyze the optical activity of charged compounds by using nuclear magnetic resonance (NMR) spectroscopy.
Measuring microRNAs in Blood to Speed Cancer Detection
A simple, ultrasensitive microRNA sensor holds promise for the design of new diagnostic strategies and, potentially, for the prognosis and treatment of pancreatic and other cancers.
Best Test to Diagnose Strangles in Horses Identified
New research by Dr. Ashley Boyle of New Bolton Center’s Equine Field Service team shows that the best method for diagnosing Strangles in horses is to take samples from a horse’s guttural pouch and analyze them using a loop-mediated amplification (LAMP) polymerase chain reaction (PCR) test.
Tardigrade's Are DNA Master Thieves
Tardigrades, nearly microscopic animals that can survive the harshest of environments, including outer space, hold the record for the animal that has the most foreign DNA.
Lucentis Effective for Proliferative Diabetic Retinopathy
NIH-funded clinical trial marks first major advance in therapy in 40 years.
Antibiotics on Our Plates 'Could Lead to Health Catastrophe'
Two medical experts from The University of Queensland are urging China to curb its use of antibiotics in animals to avoid what could be a ‘major health catastrophe’ for humans.
The Secret Behind the Power of Bacterial Sex
Migration between different communities of bacteria is the key to the type of gene transfer that can lead to the spread of traits such as antibiotic resistance, according to researchers at Oxford University.
Farming’s in Their DNA
Ancient genomes reveal natural selection in action.
Personalized Drug Screening for Multiple Myeloma Patients
A personalized method for testing the effectiveness of drugs that treat multiple myeloma may predict quickly and more accurately the best treatments for individual patients with the bone marrow 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
2,800+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,000+ scientific videos