CAMBRIDGE, Mass., Jan. 7 /PRNewswire/ -- Tolerx, Inc., today announced the completion of patient enrollment in its Phase 3 clinical study DEFEND-1, which is evaluating the safety and efficacy of otelixizumab, a targeted T cell immunomodulator, in patients with new-onset autoimmune type 1 diabetes.
Dr. Paolo Pozzilli, Professor of Endocrinology & Metabolic Diseases at the University Campus Bio-Medico in Rome, Italy, and a DEFEND-1 investigator commented: “Reaching full enrollment in DEFEND-1 is a major accomplishment for the type 1 diabetes community and furthers the development of innovative immunomodulating therapies for our patients. We will continue to work with Tolerx to further otelixizumab’s clinical development and to validate its promise of beta cell preservation in new-onset autoimmune type 1 diabetes patients.”
Tolerx also announced today its intention to conduct a second confirmatory Phase 3 study of otelixizumab in new-onset autoimmune type 1 diabetes. Further details of the design and timing of the study, to be named DEFEND-2, will be forthcoming.
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 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 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.
Tolerx, Inc.
