Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Tolerx and GlaxoSmithKline's (GSK) drug Otelixizumab has failed to meet primary endpoint in a randomized, placebo-controlled Phase 3 DEFEND-1 study.
Subscribe to our email newsletter
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.