Date: 2011-03-11
Type of information: Initiation of preclinical development
phase: 3
Announcement: results
Company: GSK (UK) ToleRX (USA)
Product: otelixizumab (humanised anti-CD3 monoclonal antibody)
Action
mechanism: monoclonal antibody. Otelixizumab targets CD3, a T lymphocyte receptor involved in normal cell signaling.
Disease: diabetes
Therapeutic area: Metabolic diseases
Country: North America, Europe
Trial details:
Latest
news: GSK and Tolerx have announced that the Phase III DEFEND-1 study of otelixizumab, an investigational humanised anti-CD3 monoclonal antibody, did not meet the primary efficacy endpoint of change in C-peptde at month 12 in patients with new-onset autoimmune type 1 diabetes. GSK will continue to explore additional dosing regimens to inform decisions about the future clinical development programme for otelixizumab. New recruitment and dosing in the DEFEND-2 study, the ongoing confirmatory Phase III study with a design similar to DEFEND-1, has been suspended pending review of the DEFEND-1 results.
