March 16, 2011

Tolerx Phase 3 Did Not Meet End Points

From The News Wire: Disappointing news for people hoping for a suppression of the autoimmune causes of type 1. I am not a rocket scientist or expert on how any branch pf science progresses so I look forward to reading  what more capable writers have to say. I am sure good friend of the blog Scott Strummello will have enlightening comments when he has had time to get all the facts. In the mean time here is the opening of the recent press statement and a link to the full release. 

Tolerx and GlaxoSmithKline Announce Phase 3 Defend-1 Study of Otelixizumab in Type 1 Diabetes Did Not Meet Its Primary Endpoint

CAMBRIDGE, Mass. and LONDON, March 11, 2011 /PRNewswire/ -- 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.  
Following preliminary review of the data, no new or unexpected treatment-related safety concerns have emerged during the DEFEND-1 study. Study investigators and regulatory agencies have been notified of the DEFEND-1 study outcome.