Efficacy and safety of low-dose otelixizumab anti-CD3 monoclonal antibody in preserving C-peptide secretion in adolescent type 1 diabetes: DEFEND-2, a randomized, placebo-controlled, double-blind, multi-centre study

Author:

Ambery P.1,Donner T. W.2,Biswas N.1,Donaldson J.1,Parkin J.1,Dayan C. M.3

Affiliation:

1. GlaxoSmithKline; Uxbridge UK

2. Division of Endocrinology; Johns Hopkins University School of Medicine; Baltimore MD USA

3. Diabetes Research Group; Institute of Molecular and Experimental Medicine; Cardiff University School of Medicine; Cardiff UK

Publisher

Wiley

Subject

Endocrinology,Endocrinology, Diabetes and Metabolism,Internal Medicine

Reference7 articles.

1. CD3-specific antibody-induced active tolerance: from bench to bedside;Chatenoud;Nat Rev Immunol,2003

2. Four-year metabolic outcome of a randomised controlled CD3-antibody trial in recent-onset type 1 diabetic patients depends on their age and baseline residual beta cell mass;Keymeulen;Diabetologia,2010

3. Partial and transient modulation of the CD3-T-cell receptor complex, elicited by low-dose regimens of monoclonal anti-CD3, is sufficient to induce disease remission in non-obese diabetic mice;Mehta;Immunology,2010

4. GlaxoSmithKline and Tolerx announce phase III DEFEND-1 study of otelixizumab in type 1 diabetes did not meet its primary endpoint http://us.gsk.com/html/media

5. http://clinicaltrials.gov/show/NCT00678886

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