Defend-1 Results Disappoint; Defend-2 Stops Enrolling

Just got back from Indy, where we got the news. Defend-1 did not turn out as expected. Defend-2 has stopped taking new patients and the rest of the study may change as a result of the findings.

The news is out on the internet:

Tolerx, Inc. and GlaxoSmithKline (GSK) today announced that the Phase 3 DEFEND-1 study of otelixizumab, an investigational humanized anti-CD3 monoclonal antibody, did not meet the primary efficacy endpoint of change in C-peptide 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 3 study with a design similar to DEFEND-1, has been suspended pending review of the DEFEND-1 results.