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

BioLineRx to Conduct Interim Analysis of Phase II/III CLARITY Trial of BL-1020

Published: Monday, October 29, 2012
Last Updated: Monday, October 29, 2012
Bookmark and Share
Results of interim analysis expected in Q1 2013.

BioLineRx has announced that it intends to conduct an interim analysis of the Phase II/III CLARITY trial of BL-1020, a first in class, orally available, GABA-enhanced antipsychotic for the treatment of schizophrenia.

The interim analysis, which is expected to be finalized in the first quarter of 2013, will be performed on data of approximately 235 randomized patients from 27 sites in Romania and India.

The primary endpoint of the analysis will be the six-week effect of the drug on cognitive function, which is a principal deficit in schizophrenia patients.

Dr. Kinneret Savitsky, CEO of BioLineRx, stated, “The recent re-analysis of BL-1020's EAGLE Phase IIb study, showing a substantially greater beneficial effect of the drug on cognitive function in schizophrenia patients, as compared to the original analysis of the study, has increased our confidence in the potential of this first-in-class drug candidate. This, together with other positive ad-hoc analyses, as well as BL-1020's excellent track record in both clinical and pre-clinical studies, has prompted us to initiate an interim analysis of the on-going CLARITY Phase II/III trial. Assuming the recruitment rate continues as planned, we expect to conduct a meaningful interim analysis of the short-term cognitive effects of BL-1020 on schizophrenic patients in the first quarter of next year. We hope that the results will reinforce our confidence regarding the cognitive benefits of the drug, and if so, will enable us to expedite our commercialization efforts for the further development of this promising therapeutic candidate. We are eagerly looking forward to the results of the interim analysis."

Earlier this month, the Company has announced that a recent re-analysis of the results of the Phase IIb EAGLE clinical trial of BL-1020 showed that, when taking into account effects of the circadian rhythm (i.e., 24-hour time cycle) on cognitive function of the subjects, BL-1020 is even more potent in improving cognitive function than initially thought.

The ramifications of this re-analysis have been taken into account in the execution of the CLARITY trial.


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
Criminal Justice Alcohol Program Linked to Decreased Mortality
Institute has announced that in the criminal justice alcohol program deaths dropped by 4.2 percent over six years.
Charting Kidney Cancer Metabolism
Changes in cell metabolism are increasingly recognized as an important way tumors develop and progress, yet these changes are hard to measure and interpret. A new tool designed by MSK scientists allows users to identify metabolic changes in kidney cancer tumors that may one day be targets for therapy.
Improving Regenerative Medicine
Lab-created stem cells may lack key characteristics, UCLA research finds.
Tick Genome Reveals Secrets of a Successful Bloodsucker
NIH has announced that decipher the genome of the blacklegged tick which could lead to new tick control methods.
"Dark Side" of the Transcriptome
New approach to quantifying gene "read-outs" reveals important variations in protein synthesis and has implications for understanding neurodegenerative diseases.
Individuals' Medical Histories Predicted by their Noncoding Genomes
Researchers have found that analyzing mutations in regions of the genome that control genes can predict medical conditions such as hypertension, narcolepsy and heart problems.
'Molecular Movie' Opens Door to New Cancer Treatments
An international team of scientists led by the University of Liverpool has produced a 'structural movie' revealing the step-by-step creation of an important naturally occurring chemical in the body that plays a role in some cancers.
New Source of Mutations in Cancer
Recently, a new mutation signature found in cancer cells was suspected to have been created by a family of enzymes found in human cells called the APOBEC3 family.
Advancing Synthetic Biology
Living systems rely on a dizzying variety of chemical reactions essential to development and survival. Most of these involve a specialized class of protein molecules — the enzymes.
Madison Researchers Begin Work on Zika Virus
Work will start with basic questions about Zika virus infection.
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!