Clinical Innovations, Inc. Will be Participating in the Phase 3 Study DEFEND - DEFEND Testing Otelixizumab in New-Onset, Type 1 Diabetes Mellitus
Costa Mesa, CA, July 15, 2009 --(PR.com)-- Clinical Innovations, Inc. announced today that it is now recruiting for DEFEND, a Phase 3 study enrolling patients with newly diagnosed autoimmune type 1 diabetes in Costa Mesa, Riverside and Santa Ana. In DEFEND (Durable Response Therapy Evaluation For Early or New-Onset Type 1 Diabetes) the safety and efficacy of otelixizumab, an investigational novel targeted immunotherapeutic anti-CD3 monoclonal antibody, are being evaluated.
Investigators with Clinical Innovations commented on the study: “We are excited to be involved in this pivotal Phase 3 study of otelixizumab. If successfully developed, otelixizumab may offer patients an innovative treatment option, consisting of a single short treatment course that may preserve residual beta cell function and improve disease control.”
About the DEFEND Study
DEFEND is a randomized, placebo-controlled Phase 3 trial designed to enroll approximately 240 young adult patients, age 18 to 35, with newly diagnosed autoimmune type 1 diabetes. DEFEND is being conducted at over 100 centers in North America and Europe. The trial is designed to evaluate whether a single course of otelixizumab, administered within 90 days of 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), reductions in hypoglycemic events, and long-term disease complications in patients with established type 1 diabetes in the Diabetes Control and Complications Trial (DCCT).
For additional information about DEFEND, please visit 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 classes of diabetes, type 1 and type 2. Type 1, previously known as juvenile diabetes or insulin-dependent diabetes, is an autoimmune disease in which the immune system attacks and destroys its own insulin-producing cells. The resulting decrease in endogenous (natural) insulin production means that patients must monitor their glucose levels frequently and take insulin to control blood glucose levels.
About Otelixizumab
Otelixizumab, an investigational novel targeted immunotherapeutic, is a 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. Data suggest that the antibody works by blocking the function of effector T cells, which mistakenly attack and destroy insulin-producing beta cells, while stimulating regulatory T cells, which are understood to protect against effector T cell damage. Thus, otelixizumab has the potential to preserve the beta cells' ability to make insulin. The efficacy and safety of otelixizumab in the treatment of type 1 diabetes is being studied in a pivotal Phase 3 study called DEFEND. Otelixizumab is being developed in type 1 diabetes by Tolerx (www.tolerx.com) in conjunction with GlaxoSmithKline (GSK)(www.gsk.com).
About Institution
Clinical Innovations is a full-service clinical research organization specializing in Phase I-IV trials with emphasis on CNS and Internal Medicine. Quality, timeliness, integrity, and openness are the key elements we bring to each clinical study.
At Clinical Innovations (CiTrials) we strive to improve the quality of healthcare "One Medical Breakthrough at a time”. Our medical staff has been serving the community healthcare needs for over 50 years.
Our studies include ADHD, Alzheimer's Disease, Autism Spectrum Disorder, Bipolar -Manic and Depressive, Type 1 and Type 2 Diabetes, Generalized Anxiety, Hypertension, Hyper-Lipidemia, Major Depressive Disorder, Migraine, Pharmacokinetics, Schizophrenia, and Schizo-affective.
For more information about participating in this study please contact them at:
Clinical Innovations
1-866-4-Study-1
1-866-478-8391
###
Investigators with Clinical Innovations commented on the study: “We are excited to be involved in this pivotal Phase 3 study of otelixizumab. If successfully developed, otelixizumab may offer patients an innovative treatment option, consisting of a single short treatment course that may preserve residual beta cell function and improve disease control.”
About the DEFEND Study
DEFEND is a randomized, placebo-controlled Phase 3 trial designed to enroll approximately 240 young adult patients, age 18 to 35, with newly diagnosed autoimmune type 1 diabetes. DEFEND is being conducted at over 100 centers in North America and Europe. The trial is designed to evaluate whether a single course of otelixizumab, administered within 90 days of 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), reductions in hypoglycemic events, and long-term disease complications in patients with established type 1 diabetes in the Diabetes Control and Complications Trial (DCCT).
For additional information about DEFEND, please visit 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 classes of diabetes, type 1 and type 2. Type 1, previously known as juvenile diabetes or insulin-dependent diabetes, is an autoimmune disease in which the immune system attacks and destroys its own insulin-producing cells. The resulting decrease in endogenous (natural) insulin production means that patients must monitor their glucose levels frequently and take insulin to control blood glucose levels.
About Otelixizumab
Otelixizumab, an investigational novel targeted immunotherapeutic, is a 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. Data suggest that the antibody works by blocking the function of effector T cells, which mistakenly attack and destroy insulin-producing beta cells, while stimulating regulatory T cells, which are understood to protect against effector T cell damage. Thus, otelixizumab has the potential to preserve the beta cells' ability to make insulin. The efficacy and safety of otelixizumab in the treatment of type 1 diabetes is being studied in a pivotal Phase 3 study called DEFEND. Otelixizumab is being developed in type 1 diabetes by Tolerx (www.tolerx.com) in conjunction with GlaxoSmithKline (GSK)(www.gsk.com).
About Institution
Clinical Innovations is a full-service clinical research organization specializing in Phase I-IV trials with emphasis on CNS and Internal Medicine. Quality, timeliness, integrity, and openness are the key elements we bring to each clinical study.
At Clinical Innovations (CiTrials) we strive to improve the quality of healthcare "One Medical Breakthrough at a time”. Our medical staff has been serving the community healthcare needs for over 50 years.
Our studies include ADHD, Alzheimer's Disease, Autism Spectrum Disorder, Bipolar -Manic and Depressive, Type 1 and Type 2 Diabetes, Generalized Anxiety, Hypertension, Hyper-Lipidemia, Major Depressive Disorder, Migraine, Pharmacokinetics, Schizophrenia, and Schizo-affective.
For more information about participating in this study please contact them at:
Clinical Innovations
1-866-4-Study-1
1-866-478-8391
###
Contact
Clinical Innovations
David Cohen
(714) 979-4101
www.citrials.com
David Cohen
(714) 979-4101
www.citrials.com
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