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

Immune Initiates Bertilimumab Phase II Clinical Trial in Ulcerative Colitis

Published: Friday, February 22, 2013
Last Updated: Friday, February 22, 2013
Bookmark and Share
Bertilimumab targets eotaxin-1, a chemokine over-expressed in ulcerative colitis patients.

Immune Pharmaceuticals Ltd. and EpiCept Corporation announced that Immune is initiating, following authorization from Israeli health authorities, a Phase II double-blind placebo controlled study with its lead drug, bertilimumab, in patients with moderate-to-severe ulcerative colitis. Bertilimumab is a first-in-class fully human monoclonal antibody targeting eotaxin-1, a chemokine small protein regulating eosinophilic inflammation.

The clinical trial is a randomized, double-blind, placebo-controlled parallel group study that will evaluate the safety, clinical efficacy, and pharmacokinetic profile of bertilimumab in subjects with active moderate-to-severe ulcerative colitis. 90 patients are expected to be enrolled into the study, 60 of whom will be treated with bertilimumab 7mg/kg and 30 of whom will be treated with placebo every two weeks, at days 0, 14, and 28. These patients will be evaluated for clinical response after six weeks to determine the decrease if any in the full Mayo Clinic Ulcerative Colitis Score. Secondary and exploratory end points will include clinical remission defined as symptom free, fecal calprotectin, a recognized marker of gastro-intestinal inflammation, histopathology improvement and degree of mucosal injury. Patient follow-up will continue up to day 90. Patients will be enrolled initially from up to 10 hospitals in Israel and later in other countries pending approval of local health authorities. Completion of patient enrollment and clinical results are anticipated in 2014.

Professor Eran Goldin, lead investigator for the clinical trial and Director of the Digestive Disease Institute at Shaare Tsedek Hospital in Jerusalem, Israel, stated, “Eotaxin-1 is a novel target which has been validated through extensive pre-clinical and observational clinical studies. The upcoming Phase II study with bertilimumab has been designed to assess the clinical relevance of neutralizing eotaxin-1 in patients with active moderate-to-severe ulcerative colitis.”

Daniel Teper, Pharm. D., CEO of Immune and Stephane Allard, M.D., Chief Medical Officer of EpiCept and designated Chief Medical Officer of the combined company following completion of the proposed merger between EpiCept and Immune, commented, “There is a clear need for alternative biological therapies for patients with ulcerative colitis. The established correlation between eotaxin-1 levels in tissue and the severity of the disease provides an opportunity to select patients most likely to respond to therapy.”

Immune and EpiCept signed a definitive agreement to merge on November 7, 2012 and currently anticipate a closing of the transaction in the second quarter of 2013. Bertilimumab will be the lead clinical stage development drug for the combined company following completion of the proposed merger.


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 3,100+ scientific posters on ePosters
  • More Than 4,500+ 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

Immune Pharma Announces Exclusive License
New technology will allow for the development of innovative drug candidates targeting immune checkpoints.
Monday, January 04, 2016
Immune Pharmaceuticals Licenses a Novel Bispecific Antibody Technology
New technology will allow for the development of innovative drug candidates targeting immune checkpoints.
Tuesday, December 29, 2015
Immune Pharmaceuticals to Take Over Epicept
The merged company will develop antibody therapeutics and other targeted drugs for the treatment of inflammatory diseases and cancer.
Friday, November 09, 2012
Scientific News
The Rise of 3D Cell Culture and in vitro Model Systems for Drug Discovery and Toxicology
An overview of the current technology and the challenges and benefits over 2D cell culture models plus some of the latest advances relating to human health research.
Grant Supports Project To Develop Simple Test To Screen For Cervical Cancer
UCLA Engineering announces funding from Bill and Melinda Gates Foundation.
Injecting New Life into Old Antibiotics
A new fully synthetic way to make a class of antibiotics called macrolides from simple building blocks is set to open up a new front in the fight against antimicrobial drug resistance.
Insight into Bacterial Resilience and Antibiotic Targets
Variant of CRISPR technology paired with computerized imaging reveals essential gene networks in bacteria.
Advancing Protein Visualization
Cryo-EM methods can determine structures of small proteins bound to potential drug candidates.
Alzheimer’s Protein Serves as Natural Antibiotic
Alzheimer's-associated amyloid plaques may be part of natural process to trap microbes, findings suggest new therapeutic strategies.
Slime Mold Reveals Clues to Immune Cells’ Directional Abilities
Study from UC San Diego identifies a protein involved in the directional ability of a slime mold.
How Do You Kill A Malaria Parasite?
Drexel University scientists have discovered an unusual mechanism for how two new antimalarial drugs operate: They give the parasite’s skin a boost in cholesterol, making it unable to traverse the narrow labyrinths of the human bloodstream. The drugs also seem to trick the parasite into reproducing prematurely.
Illuminating Hidden Gene Regulators
New super-resolution technique visualizes important role of short-lived enzyme clusters.
Supressing Intenstinal Analphylaxis in Peanut Allergy
Study from National Jewish Health shows that blockade of histamine receptors suppresses intestinal anaphylaxis in peanut allergy.
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
3,100+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,500+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!