phase 2 NCT01671956; C2a/BRT/UC-01
A Randomized, Double-Blind, Placebo-Controlled Study Designed to Evaluate the Safety, Clinical Efficacy, and Pharmacokinetic Profile of Bertilimumab in Subjects With Active Moderate to Severe Ulcerative Colitis
25 February 2013
Immune Pharmaceuticals has started Phase II study of its bertilimumab (iCo-008 or CAT-213) drug, designed for the treatment of moderate-to-severe ulcerative colitis.
Bertilimumab is a human immunoglobulin monoclonal antibody which targets eotaxin-1, a member of the chemokine family of proteins regulating eosinophilic inflammation.
The double-blind, parallel group, randomized, placebo-controlled 90 patients-based study is designed to demonstrate the safety, clinical efficacy, and pharmacokinetic profile of bertilimumab in subjects with active moderate-to-severe ulcerative colitis.
60 patients in the study will be treated with bertilimumab 7mg/kg, while 30 patients with placebo every two weeks at days 0, 14, and 28, according to the company.
In addition, the 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 of the study include clinical remission defined as symptom free, fecal calprotectin, a recognized marker of gastro-intestinal inflammation, histopathology improvement and degree of mucosal injury.
The company, which is expecting to follow-up the patients for up to day 90, said the patient enrollment and clinical results are likely to be completed in 2014.
The company has also announced that bertilimumab will be the lead clinical stage development drug for the combined company following completion of the proposed merger with EpiCept in the second quarter of 2013.
It was discovered by Cambridge Antibody Technology using their phage displaytechnology. Named CAT-213 during early discovery and development by CAT, it was to be used to treat severe allergic disorders.
In January 2007, CAT licensed the drug for treatment of allergy disorders to iCo Therapeutics Inc. iCo Therapeutics Inc. is a Vancouver-based reprofiling company focused on redosing or reformulating drugs with clinical history for new or expanded indications – a so-called ‘search and development company’.
In March 2008, iCo announced iCo-008 had been in 126 patients in Phase I and II clinical trials. The drug substance had been manufactured by Lonza, in its cGMP facilities inSlough, UK. Subsequently iCo moved the drug substance to a fill-finish site for the final stage of manufacturing. iCo reported that the iCo-008 drug product was within specifications and contained a high antibody yield.
In June 2011, IMMUNE Pharmaceuticals (Herzliya, Israel) in-licensed Bertilimumab from iCo for non-ophthalmic indications. IMMUNE is initiating Phase II clinical trials of Bertilimumab in inflammatory bowel disease (ulcerative colitis & Crohn’s disease) in 2012 and 2013.
- Bertilimumab Cambridge Antibody Technology Group. 5. November 2004. pp. 1213–8. PMID 15573873.
DR ANTHONY MELVIN CRASTO Ph.D , Born in Mumbai in 1964 and graduated from Mumbai University, Completed his PhD from ICT ,1991, Mumbai, India in Organic chemistry, The thesis topic was Synthesis of Novel Pyrethroid Analogues,
Currently he is working with GLENMARK- GENERICS LTD, Research centre as Principal Scientist, Process Research (bulk actives) at Mahape, Navi Mumbai, India.
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