Tolerx Presents Data at 69th Scientific Sessions of the American Diabetes A...( Oral Presentation Details Dose Optimi...),Health

Oral Presentation Details Dose Optimization of Pre-Clinical Otelixizumab Surrogate

NEW ORLEANS, June 8 /PRNewswire/ -- Tolerx, Inc., a biopharmaceutical company engaged in the discovery and development of novel therapies for immune-mediated diseases, today presented results from a pre-clinical dose-optimization study conducted with a surrogate of its Phase 3 anti-CD3 monoclonal antibody, otelixizumab, at the 69th Scientific Sessions of the American Diabetes Association (ADA), which is continuing until June 9, 2009 in New Orleans, Louisiana.

The presentation (#297-OR), entitled "Dose Ranging Studies of an Anti-CD3 Antibody in NOD mice to Determine Minimum Effective Dose," was part of an Oral Session on Antigen-Specific and Non-Specific Regulation of Type 1 Diabetes. In the session, Dr. Devangi Mehta, Tolerx Senior Scientist, presented data demonstrating the effects of modified dosing regimens of the anti-CD3 monoclonal antibody in a commonly used non-obese diabetic (NOD) mouse model of autoimmune diabetes.

Tolerx researchers conducted dose-ranging studies to establish the minimum effective dose and to investigate pharmacodynamic (PD) parameters, including T-cell receptor (TCR) modulation, that correlate with efficacy in a preclinical model of diabetes. Evaluation of a dose of 8ug (0.0004mg/kg) of anti-CD3 antibody, a 30-fold reduction from previously investigated dosing regimens, induced up to 53% remission of diabetes, a response rate equivalent to those achieved with a 250ug (0.0125mg/kg) dosing regimen in other studies. This result demonstrates that lower doses of anti-CD3 monoclonal antibody, causing partial TCR modulation, are efficacious in this model, and that high doses resulting in full TCR modulation are not required to achieve similar rates of remission.

These data, combined with a rigorous Phase 2 clinical development program assessing more than 10 dosing regimens, have led
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