Teplizumab, also called MGA031, is a humanized, non-Fc receptor binding, anti-CD3 monoclonal antibody. Teplizumab binds to an epitope of the CD3- epsilon chain expressed on mature T lymphocytes and, by doing so, may modulate the pathological immunologic responses underlying multiple autoimmune diseases. Specifically, teplizumab may inhibit unwanted effector T cells and enhances beneficial regulatory T cell functions, thus promoting immune tolerance.
About the PROTEGE Trial
The PROTEGE trial, a global, pivotal Phase II/III clinical trial study, is evaluating the safety and efficacy of three teplizumab dosing regimens administered at the start of the study and again at six months in individuals with recent-onset type 1 diabetes ages 8 to 35 who are up to 12 weeks from their diagnosis.
Type 1 diabetes is an autoimmune disease in which the body's immune system attacks and destroys the insulin-producing beta cells of the pancreas. Researchers believe teplizumab may control the T lymphocytes that mediate destruction of the insulin-producing beta cells of the islets of the pancreas. In doing so, they believe teplizumab may have the ability to preserve and protect the remaining beta cells of the pancreas.
Additional information regarding the PROTEGE trial is available online at http://www.protegediabetes.org.
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