Magazin
2010-01-07
Cambridge, Massachusetts (ots/PRNewswire) - Tolerx, Inc.,today announced the completion of patient enrollment in its Phase 3clinical study DEFEND-1, which is evaluating the safety and efficacyof otelixizumab, a targeted T cell immunomodulator, in patients withnew-onset autoimmune type 1 diabetes.
The DEFEND-1 (Durable Response Therapy Evaluation For Early orNew-Onset Type 1 Diabetes) study enrolled 240 patients, aged 12-45years with newly diagnosed autoimmune type 1 diabetes. The DEFEND-1study is investigating the ability of otelixizumab to preserve betacell function, which may reduce the risk of both short- and long-termcomplications of the disease. Patients will be monitored during the12-month follow-up period and c-peptide levels (a surrogate measureof beta cell function) will be measured as the primary endpoint.Secondary endpoints will evaluate the patient's ability to maintainexcellent glycemic control as measured by HbA1c levels and the amountof daily injected insulin required.
Dr. Paolo Pozzilli, Professor of Endocrinology & MetabolicDiseases at the University Campus Bio-Medico in Rome, Italy, and aDEFEND-1 investigator commented: "Reaching full enrollment inDEFEND-1 is a major accomplishment for the type 1 diabetes communityand furthers the development of innovative immunomodulating therapiesfor our patients. We will continue to work with Tolerx to furtherotelixizumab's clinical development and to validate its promise ofbeta cell preservation in new-onset autoimmune type 1 diabetespatients."
Peter A. Gottlieb, MD, Associate Professor of Pediatrics andMedicine at the Barbara Davis Center at the University of Colorado atDenver, known for his involvement in many types of clinical trialsfor the prevention and treatment of diabetes, noted that, "Thecontinuous otelixizumab dose regimen optimization efforts have been amajor translational research focus. These important research effortsare enabling us, in the DEFEND development program, to evaluate thepotential ability of otelixizumab to provide a long-term immunologicremission after a short course of therapy. If successful in theclinic, this would be a significant step forward."
Tolerx also announced today its intention to conduct a secondconfirmatory Phase 3 study of otelixizumab in new-onset autoimmunetype 1 diabetes. Further details of the design and timing of thestudy, to be named DEFEND-2, will be forthcoming.
"The on-time completion of patient enrollment in DEFEND-1represents a major milestone for Tolerx," said Dr. Douglas J.Ringler, President and Chief Executive Officer of Tolerx. "We arevery grateful for the dedication of the patients, their caregiversand our clinical trial investigators for making it possible to reachour enrollment target. As part of our clinical development program toreach regulatory approval for otelixizumab, we will now quicklytransition to the launch of DEFEND-2, a confirmatory study, tomaintain enrollment momentum and enthusiasm generated to date in thetype 1 diabetes community."
About the DEFEND-1 Study
DEFEND-1 is a randomized, placebo-controlled Phase 3 study thathas achieved its target enrollment of 240 patients, age 12 to 45,with newly diagnosed autoimmune type 1 diabetes. DEFEND is beingconducted at over 100 study centers throughout Europe and NorthAmerica. The study is designed to evaluate whether a single course ofotelixizumab, administered not more than 90 days after the initialdiagnosis of autoimmune type 1 diabetes, will preserve beta cellfunction as measured by c-peptide, a surrogate measure of beta cellfunction. The primary endpoint is measurement of c-peptide. For moreinformation about DEFEND, please visit www.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 targeted T cell immunomodulator being developedfor the 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' ability to make insulin.
About Tolerx
Tolerx, Inc., a world leader in the understanding of T cellfunction, is developing novel therapies intended to treat autoimmunediseases, diabetes, and cancer by specifically modulating T-cellactivity. The company's pipeline includes its lead candidate,otelixizumab, a targeted T-cell immunomodulator partnered withGlaxoSmithKline in Phase 3 development for the treatment of type 1diabetes; a Phase 1 candidate, MTRX1011A, an anti-CD4 antibody thatis being developed in collaboration with Genentech, Inc. for thetreatment of autoimmune indications; and two pre-clinical candidates,TRX518 and TRX385, that enhance immune responses and are beingevaluated for potential benefit in the treatment of cancer, chronicviral diseases, and as vaccine adjuvants. Tolerx is a privately heldcompany headquartered in Cambridge, MA USA. For more information,please visit www.tolerx.com.
ots Originaltext: Tolerx, Inc.Im Internet recherchierbar: http://www.presseportal.de
Contact:CONTACT: Jessica Johnson of Tolerx, Inc., +1-617-452-1356
Tolerx Completes Enrollment in DEFEND-1, A Phase 3 Type 1 Diabetes Study With Otelixizumab
Cambridge, Massachusetts (ots/PRNewswire) - Tolerx, Inc.,today announced the completion of patient enrollment in its Phase 3clinical study DEFEND-1, which is evaluating the safety and efficacyof otelixizumab, a targeted T cell immunomodulator, in patients withnew-onset autoimmune type 1 diabetes.
The DEFEND-1 (Durable Response Therapy Evaluation For Early orNew-Onset Type 1 Diabetes) study enrolled 240 patients, aged 12-45years with newly diagnosed autoimmune type 1 diabetes. The DEFEND-1study is investigating the ability of otelixizumab to preserve betacell function, which may reduce the risk of both short- and long-termcomplications of the disease. Patients will be monitored during the12-month follow-up period and c-peptide levels (a surrogate measureof beta cell function) will be measured as the primary endpoint.Secondary endpoints will evaluate the patient's ability to maintainexcellent glycemic control as measured by HbA1c levels and the amountof daily injected insulin required.
Dr. Paolo Pozzilli, Professor of Endocrinology & MetabolicDiseases at the University Campus Bio-Medico in Rome, Italy, and aDEFEND-1 investigator commented: "Reaching full enrollment inDEFEND-1 is a major accomplishment for the type 1 diabetes communityand furthers the development of innovative immunomodulating therapiesfor our patients. We will continue to work with Tolerx to furtherotelixizumab's clinical development and to validate its promise ofbeta cell preservation in new-onset autoimmune type 1 diabetespatients."
Peter A. Gottlieb, MD, Associate Professor of Pediatrics andMedicine at the Barbara Davis Center at the University of Colorado atDenver, known for his involvement in many types of clinical trialsfor the prevention and treatment of diabetes, noted that, "Thecontinuous otelixizumab dose regimen optimization efforts have been amajor translational research focus. These important research effortsare enabling us, in the DEFEND development program, to evaluate thepotential ability of otelixizumab to provide a long-term immunologicremission after a short course of therapy. If successful in theclinic, this would be a significant step forward."
Tolerx also announced today its intention to conduct a secondconfirmatory Phase 3 study of otelixizumab in new-onset autoimmunetype 1 diabetes. Further details of the design and timing of thestudy, to be named DEFEND-2, will be forthcoming.
"The on-time completion of patient enrollment in DEFEND-1represents a major milestone for Tolerx," said Dr. Douglas J.Ringler, President and Chief Executive Officer of Tolerx. "We arevery grateful for the dedication of the patients, their caregiversand our clinical trial investigators for making it possible to reachour enrollment target. As part of our clinical development program toreach regulatory approval for otelixizumab, we will now quicklytransition to the launch of DEFEND-2, a confirmatory study, tomaintain enrollment momentum and enthusiasm generated to date in thetype 1 diabetes community."
About the DEFEND-1 Study
DEFEND-1 is a randomized, placebo-controlled Phase 3 study thathas achieved its target enrollment of 240 patients, age 12 to 45,with newly diagnosed autoimmune type 1 diabetes. DEFEND is beingconducted at over 100 study centers throughout Europe and NorthAmerica. The study is designed to evaluate whether a single course ofotelixizumab, administered not more than 90 days after the initialdiagnosis of autoimmune type 1 diabetes, will preserve beta cellfunction as measured by c-peptide, a surrogate measure of beta cellfunction. The primary endpoint is measurement of c-peptide. For moreinformation about DEFEND, please visit www.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 targeted T cell immunomodulator being developedfor the 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' ability to make insulin.
About Tolerx
Tolerx, Inc., a world leader in the understanding of T cellfunction, is developing novel therapies intended to treat autoimmunediseases, diabetes, and cancer by specifically modulating T-cellactivity. The company's pipeline includes its lead candidate,otelixizumab, a targeted T-cell immunomodulator partnered withGlaxoSmithKline in Phase 3 development for the treatment of type 1diabetes; a Phase 1 candidate, MTRX1011A, an anti-CD4 antibody thatis being developed in collaboration with Genentech, Inc. for thetreatment of autoimmune indications; and two pre-clinical candidates,TRX518 and TRX385, that enhance immune responses and are beingevaluated for potential benefit in the treatment of cancer, chronicviral diseases, and as vaccine adjuvants. Tolerx is a privately heldcompany headquartered in Cambridge, MA USA. For more information,please visit www.tolerx.com.
ots Originaltext: Tolerx, Inc.Im Internet recherchierbar: http://www.presseportal.de
Contact:CONTACT: Jessica Johnson of Tolerx, Inc., +1-617-452-1356
Tolerx, Inc. Homepage ,Story,Pressemappe
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