Otelixizumab misses diabetes endpoint

Tolerx Inc. (Cambridge, Mass.) and partner GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) said IV otelixizumab missed the primary endpoint of maintaining baseline C-peptide levels at 12 months vs. placebo in the Phase III DEFEND-1 trial to treat new-onset Type I diabetes. The double-blind, international trial enrolled 272 patients ages 12-45. As a result, new enrollment and dosing in the similar Phase III DEFEND-2 trial of the humanized anti-CD3 mAb has been suspended pending review of the DEFEND-1 data.

GSK said it will continue to explore additional dosing regimens to inform its plans for future development of the compound. Otelixizumab is also in Phase II testing for rheumatoid arthritis (RA). In 2001, BTG plc (LSE:BGC) granted worldwide rights for otelixizumab to Tolerx, which in turn granted GSK rights to develop and commercialize the product. BTG gained 1.90p to 217.60p on Friday. ...