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Tolerx Presents Baseline Data from DEFEND-1 Study Validating C-Peptide as Critical Clinical Measure for New-Onset Type 1 Diabetes
Date:6/28/2010

ORLANDO, Fla., June 28 /PRNewswire/ -- Tolerx, Inc., a biopharmaceutical company developing novel therapies to treat autoimmune diseases and cancer by modulating T cell activity, today presented an analysis of baseline data from the Phase 3 DEFEND-1 clinical trial of otelixizumab in patients with autoimmune new onset type 1 diabetes.  The analysis showed that higher C-peptide levels had a statistically significant correlation with a decrease in two distinct measurements of glucose variability, confirming that C-peptide is a robust clinical marker for beta cell function which becomes impaired in type 1 diabetes.  Measurement of C-peptide has been endorsed by FDA as the primary endpoint for clinical trials of therapies that are designed to preserve beta cell function in new-onset type 1 diabetes and is the primary endpoint to evaluate the efficacy of otelixizumab in the DEFEND-1 clinical trial, with results from DEFEND-1 expected in the first half of 2011.  

The pre-dose baseline data from DEFEND-1 represents one of the first comprehensive studies to correlate higher C-peptide levels with lower blood glucose variability in patients with type 1 diabetes.  These results are clinically meaningful because blood glucose variability may be a risk factor for short- and long-term complications, including severe hypoglycemia and microvascular disease, in patients with type 1 diabetes.  The analysis from the DEFEND-1 study was presented at a poster session of the 70th Scientific Sessions of the American Diabetes Association (ADA) taking place June 25 through June 29 in Orlando, Florida. 

"We are gratified that the analysis of baseline data from our DEFEND-1 clinical trial may contribute to a better understanding of new-onset type 1 diabetes and
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SOURCE Tolerx, Inc.
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