Otelixizumab, an investigational humanized anti-CD3 monoclonal antibody, is a targeted T cell immunotherapy being developed for the treatment of type 1 diabetes and other autoimmune diseases.
Following preliminary review of the data, no new or unexpected treatment-related safety concerns have emerged during the DEFEND-1 study.
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 3 study with a design similar to DEFEND-1, has been suspended pending review of the DEFEND-1 results.
Earlier, Tolerx and GSK entered into a pact in In October 2007 for development and commercialization of Otelixizumab for a range of autoimmune and immune-mediated inflammatory diseases, including type 1 diabetes.
Tolerx president and CEO Douglas Ringler said while they are disappointed in the DEFEND-1 results of Otelixizumab, they remain committed to the development and commercialization of the candidates in the pipeline, each of which has a distinct mechanism and target for correcting abnormal immune responses.