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.