2009-03-10

Tolerx Expands Phase 3 'DEFEND' Trial of Otelixizumab in Europe


Cambridge, Massachusetts (ots/PRNewswire) -

Tolerx, Inc., today announced that DEFEND (Durable ResponseTherapy Evaluation For Early or New Onset Type 1 Diabetes), the Phase3 trial of otelixizumab, an investigational novel targetedimmunotherapeutic, has begun enrollment of new onset autoimmune type1 diabetes patients in Europe. In DEFEND, preserving beta cellfunction subsequent to the administration of otelixizumab is theprimary outcome that is being evaluated. This outcome will beassessed by measuring C-peptide levels (a surrogate of endogenousinsulin secretion) and by measuring reductions in the amount ofinjected insulin used to maintain excellent glycemic control.

DEFEND continues to actively recruit subjects in the UnitedStates, Canada, Sweden, Finland, Germany, Italy, and the UK. Tolerxanticipates that enrollment will soon commence at clinical sites inSpain and Denmark.

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

"We are pleased that an increasing number of excellent clinicalresearchers in Europe and North America have started DEFEND at theirsites and look forward to their continued participation in thisimportant effort. We believe that a single short course ofotelixizumab may have the potential to preserve residual beta cellfunction and offer people with autoimmune type 1 diabetes improveddisease control" said Dr. Louis Vaickus, Chief Medical Officer ofTolerx. He continued "We are seeking in DEFEND to conclusivelydemonstrate this understanding."

About the DEFEND Study

DEFEND is a randomized, placebo-controlled Phase 3 trial designedto enroll approximately 240 adult patients, age 18 to 35, with newlydiagnosed autoimmune type 1 diabetes. DEFEND is being conducted atmultiple centers throughout Europe and North America. The trial isdesigned to evaluate whether a single course of otelixizumab,administered not more than 90 days after the initial diagnosis ofautoimmune type 1 diabetes, will reduce the amount of administeredinsulin required to control blood glucose levels by inhibiting thedestruction of beta cells. The primary endpoint will be a measurementof C-peptide, a surrogate measure of beta cell function. Foradditional information about DEFEND, please visitwww.DefendAgainstDiabetes.com

About Type 1 Diabetes

Diabetes (medically known as diabetes mellitus) is the name givento disorders in which the body has difficulty regulating its bloodglucose (sugar) level. There are two major types of diabetes: type 1and type 2. Type 1, previously known as juvenile diabetes orinsulin-dependent diabetes, is a disorder of the body's immunesystem. In type 1 diabetes, the immune system attacks and destroysthe insulin-producing beta cells in the pancreas. As a result of thedecrease in endogenous (natural) insulin production, patients mustmonitor their glucose levels frequently and administer insulinregularly to control their blood glucose levels.

About Otelixizumab

Otelixizumab is a novel monoclonal antibody being developed forthe treatment of type 1 diabetes and other autoimmune diseases.Otelixizumab targets CD3, a T lymphocyte receptor involved in normalcell signaling. Otelixizumab has not yet been approved for marketing.Data suggest that the antibody may work in patients with type 1diabetes who have residual beta cells by blocking the function ofeffector T cells that mistakenly attack and destroy insulin-producingbeta cells, while stimulating regulatory T cells that are understoodto protect against effector T cell damage, thus preserving the betacells' normal ability to make insulin. For further information of howotelixizumab may work, please see www.tolerx.com otelixizumab pageand watch our animation.

About Tolerx

Tolerx is a biopharmaceutical company engaged in the discoveryand development of novel therapies for immune-mediated diseases. Thecompany's pipeline includes its lead candidate, otelixizumab, ananti-CD3 monoclonal antibody partnered with GlaxoSmithKline in Phase3 development for the treatment of type 1 diabetes; a Phase 1candidate, MTRX1011A, an anti-CD4 antibody that is being developed incollaboration with Genentech, Inc. for the treatment of autoimmuneindications; and two pre-clinical candidates, TRX518 and TRX385, thatenhance immune responses and are being evaluated for potentialbenefit in the treatment of cancer, chronic viral diseases, and asvaccine adjuvants. Tolerx is a privately held company headquarteredin Cambridge, MA USA. For more information, please visitwww.tolerx.com.

Tolerx Forward-Looking Statements

This press release contains certain statements that are precededby, followed by, or that include the words "will," "will be,"anticipates," "potential," "look forward," or similar expressions orthe negation thereof. Such statements, which are not historicalfacts, constitute "forward-looking statements." Statements regardingthe outcomes sought to be realized in the DEFEND and the possibilitythat otelixizumab may preserve beta cell function, may be apotentially effective treatment option, or may constitute aninnovative immune intervention for type 1 diabetes, are allforward-looking statements. Such forward-looking statements involverisks, uncertainties and other factors that may cause the actualperformance or achievements of Tolerx to be materially different fromany future results, performance, or achievements expressed or impliedby such forward-looking statements. Tolerx undertakes no obligationto update or revise any forward-looking statements to reflect eventsor circumstances after the date of this press release.

ots Originaltext: Tolerx, Inc.Im Internet recherchierbar: http://www.presseportal.de

Contact:Jessica Snyder, Corporate Communications of Tolerx, Inc., +1-617-452-1300, jsnyder@tolerx.com

Tolerx, Inc.

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Tolerx Expands Phase 3 'DEFEND' Trial of Otelixizumab in Europe

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