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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

to clinically meaningful outcomes for patients.  It is compelling that these data showed a strong correlation between blood glucose variability and C-peptide, particularly because glucose variability was measured with basic finger stick blood glucose testing. Tolerx is seeking additional and more robust data from the ongoing confirmatory Phase 3 DEFEND-2 study in which all subjects will wear a continuous glucose monitor (CGM) at regular intervals," said Aoife Brennan, MD, endocrinologist and Associate Medical Director at Tolerx.  "Our Phase 3 DEFEND-1 and DEFEND-2 clinical trials aim to show that otelixizumab is not only safe and well tolerated, but that it preserves beta cell function."

The Tolerx data presentation at ADA (abstract #700-P), entitled "Lower C-Peptide Secretion Is Associated With Increased Blood Glucose Variability In Adults With New-Onset Type 1 Diabetes: Analysis Of Baseline Data From DEFEND-1," reviewed data from patients within 90 days of diagnosis with new-onset diabetes, monitoring their blood glucose 7 times per day for 7 days prior to the date when the patients began dosing with Tolerx's investigational product candidate, otelixizumab. Two measurements of glucose variability were evaluated for relationship to C-peptide: average daily risk range (ADRR) and mean amplitude of glycemic excursions (MAGE).   With a decrease in each measure of glucose variability, ADRR and MAGE, there was a statistically significant correlation with an increase in C-peptide.  The results demonstrate the relationship between glucose variability and C-peptide, confirming that C-peptide is a robust and important clinical marker for beta cell function and glycemic control.

About the DEFEND-1 Study

DEFEND-1 is a randomized, placebo-controlled Phase 3 study that has achieved its target enrollment of 240 patients, age 12
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SOURCE Tolerx, Inc.
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