Tolerx Presents Baseline Data from DEFEND-1 Study Validating C-Peptide as Critical Clinical Measure for New-Onset Type 1 Diabetes

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 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 to 45, with newly diagnosed autoimmune type 1 diabetes. DEFEND-1 is being conducted at over 100 study centers throughout Europe and North America.  The study is designed to evaluate whether a single course of otelixizumab, administered not more than 90 days after the initial diagnosis of autoimmune type 1 diabetes, will preserve beta cell function as measured by C-peptide, a surrogate measure of beta cell function.  The primary endpoint is measurement of C-peptide.  For more information about DEFEND, please visit www.DefendAgainstDiabetes.com.

About Type 1 Diabetes

Diabetes (medically known as diabetes mellitus) is the name given to disorders in which the body has difficulty regulating its blood glucose (sugar) level.  There are two major types of diabetes:  type 1 and type 2. Type 1, previously known as juvenile diabetes or insulin-dependent diabetes, is a disorder involving the body's immune system.  In type 1 diabetes, the immune system attacks and destroys the insulin-producing beta cells in the pancreas.  As a result of the decrease in endogenous (natural) insulin production, patients must monitor their glucose levels frequently and administer insulin regularly to control their blood glucose levels. 

About Otelixizumab

Otelixizumab is a targeted T cell immunomodulator being developed for the treatment of type 1 diabetes and other autoimmune diseases.  Otelixizumab targets CD3, a T lymphocyte receptor involved in normal cell signaling.  Otelixizumab has not yet been approved for marketing. Data suggest that the antibody may work in patients with type 1 diabetes who have residual beta cells by blocking the function of effector T cells that mistakenly attack and destroy insulin-producing beta cells, while stimulating regulatory T cells that are understood to protect against effector T cell damage, thus preserving the beta cells' ability to make insulin. 

About Tolerx

Tolerx, Inc., a world leader in the understanding of T cell function, is developing novel therapies intended to treat autoimmune diseases, diabetes, and cancer by specifically modulating T cell activity.  The company's pipeline includes its lead candidate, otelixizumab, a targeted T cell immunomodulator in Phase 3 development for the treatment of type 1 diabetes that is partnered with GlaxoSmithKline.  TRX1, a Phase 1 candidate, is a nonlytic anti-CD4 antibody that is being developed for the treatment of aberrant or untoward immune responses.  The company also has three pre-clinical candidates, TRX518, TRX585 and TRX385, that enhance immune responses and as such are being evaluated for potential benefit in the treatment of cancer and chronic infections. Tolerx is a privately held company headquartered in Cambridge, MA USA.  For more information, please visit www.tolerx.com.

SOURCE Tolerx, Inc.

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