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

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
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
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
Scientific News
Lucentis Effective for Proliferative Diabetic Retinopathy
NIH-funded clinical trial marks first major advance in therapy in 40 years.
Blocking the Transmission Of Malaria Parasites
Vaccine candidate administered for the first time in humans in a phase I clinical trial led by Oxford University’s Jenner Institute, with partners Imaxio and GSK.
First Therapy Appearing to Reverse Decline in Parkinson’s
An FDA-approved drug for leukemia improved cognition, motor skills and non-motor function in patients with Parkinson’s disease and Lewy body dementia in a small clinical trial, say researchers at Georgetown University Medical Center (GUMC).
Gene Therapy Staves Off Blindness from Retinitis Pigmentosa in Canine Model
NIH-funded study suggests therapeutic window may extend to later-stage disease.
Treatment for Rare Bleeding Disorder is Effective
Researchers in Manchester have demonstrated for the first time the relative safety and effectiveness of treatment, eltrombopag, in children with persistent or chronic immune thrombocytopenia (ITP), as part of an international duo of studies.
HIV Vaccine Human Trials Begin
Baltimore-based Institute has begun enrolling volunteers for initial phase 1 clinical trials.
New Therapy Reduces Symptoms of Inherited Enzyme Deficiency
A phase three clinical trial of a new enzyme replacement medication, sebelipase alfa, showed a reduction in multiple disease-related symptoms in children and adults with lysosomal acid lipase deficiency, an inherited enzyme deficiency that can result in scarring of the liver and high cholesterol.
Fixing Holes in the Heart Without Invasive Surgery
UV-light enabled catheter is a medical device which represents a major shift in how cardiac defects are repaired.
Atriva Therapeutics GmbH Develops Innovative Flu Drug
Highly effective against seasonal and pandemic influenza.
Study Removes Cancer Doubt for Multiple Sclerosis Drug
Researchers from Queen Mary University of London are calling on the medical community to reconsider developing a known drug to treat people with relapsing Multiple sclerosis after new evidence shows it does not increase the risk of cancer as previously thought.
Scroll Up
Scroll Down

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