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Following preliminary review of the data, no new or unexpected treatment-related safety concerns have emerged during the DEFEND-1 study. Study investigators and regulatory agencies have been notified of the DEFEND-1 study outcome.
GSK will continue to explore additional dosing regimens to inform decisions about the future clinical development program for otelixizumab. New recruitment and dosing in the DEFEND-2 study, the ongoing confirmatory Phase 3 study with a design similar to DEFEND-1, has been suspended pending review of the DEFEND-1 results.
Douglas J. Ringler, VMD, President and Chief Executive Officer of Tolerx stated that, “While we are disappointed in the DEFEND-1 results of otelixizumab, we remain committed to the development and commercialization of the candidates in our pipeline, each of which has a distinct mechanism and target for correcting abnormal immune responses.” said. “Our immunotherapy candidates represent some of the latest scientific advances in harnessing the immune system for therapeutic benefit, including TRX518 which is a showpiece of our pipeline as an immunotherapy to treat cancer.”
“Clearly these are disappointing data, but we are committed to working with Tolerx to better understand the results of this study and determine the way forward,” said Jackie Parkin, Medicines Development Leader, GlaxoSmithKline.
Otelixizumab, an investigational humanized anti-CD3 monoclonal antibody, is a targeted T cell immunotherapy 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.
DEFEND-1 is a randomized, placebo-controlled Phase 3 study of 272 patients, age 12 to 45, with new-onset Type 1 diabetes. DEFEND-1 was conducted at over 100 study centers throughout North America and Europe. The study was designed to evaluate whether a single 8-day intravenous course of otelixizumab (3.1mg), administered not more than 90 days after the initial diagnosis of autoimmune Type 1 diabetes, preserved the function of insulin-producing beta cells in the pancreas, as measured by C-peptide. Measurement of C-peptide (a protein that shows how much insulin the body is producing) at 12 months after dosing was the primary endpoint in DEFEND-1 and is a well established surrogate measure of beta cell function and a recommended endpoint by the U.S. Food and Drug Administration (FDA) and the American Diabetes Association.
Source: Tolerx, Inc