TolerRx(TRX4) Gets Orphan Drug Designation for Treatment of New-Onset Type 1 Dia

TolerRx(TRX4) Gets Orphan Drug Designation for Treatment of New-Onset Type 1 Diabetes

TRX4 was shown to preserve the function of insulin-producing beta cells in the pancreas.

In a study of subjects with new-onset Type 1 diabetes published in the June 23, 2005 edition of the New England Journal of Medicine, TRX4 (ChAglyCD3) was shown to preserve the function of insulin-producing beta cells in the pancreas and reduce the amount of administered insulin needed to control blood glucose levels for at least 18 months after a single six day course of TRX4. At the doses used in this study, TRX4 administration was associated with transient symptoms of flu-like syndrome and transient EBV reactivation. TolerRx recently initiated a clinical trial in the U.S. in subjects with Type 1 diabetes designed to optimize and select a TRX4 dosing regimen to be used in later phase trials.

TRX4 is a monoclonal antibody that binds to a receptor found on all T cells called CD3, which is involved in normal T cell signaling. TRX4 is designed to block the function of autoreactive T-effector cells that attack the body’s tissues and cause autoimmune disease. Because T-effector cells and T-regulatory cells utilize different signaling pathways for activation, TRX4 is expected to suppress autoreactive T cells while promoting T-regulatory cell activity, resulting in a state of immunological tolerance. In addition to Type 1 diabetes.

TolerRx, Inc.

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