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Otelixizumab Trial for New Onset Type 1 Diabetes Launched

CAMBRIDGE, Mass., Aug. 6 /PRNewswire/ -- Tolerx, Inc., a biopharmaceutical company engaged in the discovery and development of novel therapies for immune-mediated diseases, today announced the initiation of a pivotal Phase 3 clinical trial that is evaluating otelixizumab in autoimmune new onset type 1 diabetes. As a result of the initiation of patient dosing in DEFEND (Durable Response Therapy Evaluation For Early or New Onset Type 1 Diabetes), Tolerx will receive a $15 million milestone payment from GlaxoSmithKline.

DEFEND is a randomized, placebo controlled Phase 3 trial designed to enroll approximately 240 adult patients, age 18 to 35, with newly diagnosed autoimmune type 1 diabetes. DEFEND is being conducted at multiple centers in North America and Europe. The trial will evaluate whether a single course of otelixizumab, administered not more than 90 days after the initial diagnosis of autoimmune type 1 diabetes, will reduce the amount of administered insulin required to control blood glucose levels by inhibiting the destruction of beta cells. The primary endpoint will be a measurement of C-peptide, a surrogate measure of beta cell function. Maintenance of beta cell function has been associated with improved glycemic control (HbA1c levels), fewer hypoglycemic events, and a reduction in long-term disease complications in established type 1 diabetics in the Diabetes Control and Complications Trial (DCCT).

"We are excited to have dosed the first patient in DEFEND and look forward to continued patient enrollment in this Phase 3 clinical trial. The initiation of DEFEND represents the culmination of a methodical, dose-ranging development plan, including the successful outcome from an end-of-Phase 2 meeting at FDA. We believe otelixizumab has the potential to provide an important new treatment option for patients with newly diagnosed autoimmune type 1 diabetes," said Dr. Douglas J. Ringler, President and Chief Executive Officer of Tolerx.

For additional information about DEFEND, please visit http://www.defendagainstdiabetes.com/.

About Type 1 Diabetes
Diabetes (medically known as diabetes mellitus) is the name given to disorders in which the body has difficulty regulating its blood glucose (sugar) level. There are two major types of diabetes: type 1 and type 2. Type 1, previously known as juvenile diabetes or insulin-dependent diabetes, is a disorder of the body's immune system. In type 1 diabetes, the immune system attacks and destroys the insulin-producing beta cells in the pancreas. The decrease in endogenous (natural) insulin production means that patients must monitor their glucose levels frequently and take insulin regularly to control their blood glucose levels.

About Otelixizumab
Otelixizumab is a monoclonal antibody that binds to CD3, a T lymphocyte receptor involved in normal cell signaling. Otelixizumab is thought to work by blocking the function of effector T cells that attack the body's tissues and cause autoimmune disease while inducing a subset of T cells known as regulatory T cells. It is thought that the regulatory T cells may protect against effector T cell damage well after the antibody has been eliminated from the body. In addition to DEFEND, Tolerx is also continuing to evaluate otelixizumab in subjects with type 1 diabetes in its ongoing Phase 2 study, TTEDD (TRX4 Therapeutic Evaluation of Different Dosing Regimens). A principal purpose of TTEDD is to evaluate different dosing regimens in an effort to reduce side effects and to acquire additional information about otelixizumab's clinical activity. Tolerx has conducted dose optimization studies in type 1 diabetes and has identified a dosing regimen that thus far has significantly reduced side effects while maintaining important biological activity. This dosing regimen is being used in DEFEND. For more information on DEFEND, please see http://www.defendagainstdiabetes.com/.

Source: Tolerx, Inc.

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