Tolerx Expands Phase 3 'DEFEND' Trial Of Otelixizumab In Europe

Main Category: Diabetes
Also Included In: Clinical Trials / Drug Trials
Article Date: 10 Mar 2009 - 5:00 PDT

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Tolerx, Inc., today announced that DEFEND (Durable Response Therapy Evaluation For Early or New Onset Type 1 Diabetes), the Phase 3 trial of otelixizumab, an investigational novel targeted immunotherapeutic, has begun enrollment of new onset autoimmune type 1 diabetes patients in Europe. In DEFEND, preserving beta cell function subsequent to the administration of otelixizumab is the primary outcome that is being evaluated. This outcome will be assessed by measuring C-peptide levels (a surrogate of endogenous insulin secretion) and by measuring reductions in the amount of injected insulin used to maintain excellent glycemic control.

DEFEND continues to actively recruit subjects in the United States, Canada, Sweden, Finland, Germany, Italy, and the UK. Tolerx anticipates that enrollment will soon commence at clinical sites in Spain and Denmark.

"Our participation in DEFEND reflects our research priorities to support the development of innovative immune intervention for type 1 diabetes patients. We have begun dosing otelixizumab in DEFEND and are excited about its potential to be an effective treatment option for type 1 diabetics," stated Dr. Paolo Pozzilli, Professor University Campus Bio-Medico, Rome Italy.

"We are pleased that an increasing number of excellent clinical researchers in Europe and North America have started DEFEND at their sites and look forward to their continued participation in this important effort. We believe that a single short course of otelixizumab may have the potential to preserve residual beta cell function and offer people with autoimmune type 1 diabetes improved disease control" said Dr. Louis Vaickus, Chief Medical Officer of Tolerx. He continued "We are seeking in DEFEND to conclusively demonstrate this understanding."

About the DEFEND Study

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 throughout Europe and North America. The trial 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 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. 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. As a result of the decrease in endogenous (natural) insulin production, patients must monitor their glucose levels frequently and administer insulin regularly to control their blood glucose levels.

About Otelixizumab

Otelixizumab is a novel monoclonal antibody 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' normal ability to make insulin. For further information of how otelixizumab may work, please see www.tolerx.com otelixizumab page and watch our animation.

About Tolerx

Tolerx is a biopharmaceutical company engaged in the discovery and development of novel therapies for immune-mediated diseases. The company's pipeline includes its lead candidate, otelixizumab, an anti-CD3 monoclonal antibody partnered with GlaxoSmithKline in Phase 3 development for the treatment of type 1 diabetes; a Phase 1 candidate, MTRX1011A, an anti-CD4 antibody that is being developed in collaboration with Genentech, Inc. for the treatment of autoimmune indications; and two pre-clinical candidates, TRX518 and TRX385, that enhance immune responses and are being evaluated for potential benefit in the treatment of cancer, chronic viral diseases, and as vaccine adjuvants. Tolerx is a privately held company headquartered in Cambridge, MA USA. For more information, please visit http://www.tolerx.com.

Tolerx Forward-Looking Statements

This press release contains certain statements that are preceded by, followed by, or that include the words "will," "will be," anticipates," "potential," "look forward," or similar expressions or the negation thereof. Such statements, which are not historical facts, constitute "forward-looking statements." Statements regarding the outcomes sought to be realized in the DEFEND and the possibility that otelixizumab may preserve beta cell function, may be a potentially effective treatment option, or may constitute an innovative immune intervention for type 1 diabetes, are all forward-looking statements. Such forward-looking statements involve risks, uncertainties and other factors that may cause the actual performance or achievements of Tolerx to be materially different from any future results, performance, or achievements expressed or implied by such forward-looking statements. Tolerx undertakes no obligation to update or revise any forward-looking statements to reflect events or circumstances after the date of this press release.

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