Clinical Trials of America, Inc., Participating in Pivotal Clinical Study of Novel Treatment for Type 1 Diabetes
Defend-2 Evaluating Drug Candidate, Otelixizumab, in New-Onset Type 1 Diabetes.
Eugene, OR, November 06, 2010 --(PR.com)-- Dr. Aaron Pardini announced today that he is now recruiting for DEFEND-2, a confirmatory Phase 3 study enrolling patients with newly diagnosed autoimmune type 1 diabetes, in Eugene. In DEFEND-2 (Durable-Response Therapy Evaluation For Early or New-Onset Type 1 Diabetes), the safety and efficacy of otelixizumab, an investigational anti-CD3 monoclonal antibody, is being evaluated.
Dr. Pardini at Clinical Trials of America commented on the study: “We are excited to be involved in this clinical study of a potential new treatment which would intervene in disease progression at the onset of type 1 diabetes. If successful, otelixizumab may offer patients an innovative treatment option, consisting of a single short treatment course that may improve type 1 diabetes disease control.”
About the DEFEND Program
The DEFEND program consists of two Phase 3 studies, DEFEND-1 and DEFEND-2, assessing the safety and efficacy of otelixizumab in new-onset autoimmune type 1 diabetes. The program is designed to evaluate whether a single short course of otelixizumab, a targeted T cell anti-CD3 monoclonal antibody, administered within 90 days after the initial diagnosis of diabetes, will preserve beta cell function as measured by C-peptide. The primary endpoint in both studies is change in C-peptide 12 months after study drug administration. Both studies are being conducted at centers throughout North America and Europe. DEFEND-1 is a randomized, double-blind, placebo-controlled Phase 3 study that completed enrollment of 240 patients, ages 12 to 45, in early 2010. Similar to DEFEND-1 in design, DEFEND-2 seeks to enroll up to approximately 400 patients, ages 12 to 45, within 90 days of diagnosis of diabetes. For more information about the DEFEND program, 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 (beta cells). T lymphocytes called effector T cells mistakenly attack and destroy these insulin-producing beta cells, in the pancreas. The resulting decrease in endogenous (natural) insulin production means that patients must monitor their glucose levels frequently and give themselves insulin by injection or pump to control blood glucose levels.
About Otelixizumab
Otelixizumab is a targeted T cell immunomodulator 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, while stimulating regulatory T cells that are understood to protect against effector T cell damage, thus preserving the beta cells' ability to make insulin. The efficacy and safety of otelixizumab in the treatment of type 1 diabetes is being studied in the DEFEND program. Otelixizumab is being developed in type 1 diabetes by Tolerx (www.tolerx.com) in collaboration with GlaxoSmithKline (www.gsk.com).
About Clinical Trials of America, Inc.
A physician founded and operated clinical trial company, Clinical Trials of America is driven by a team of dedicated, experienced professionals who are passionate about research. Dr Aaron Pardini is a board certified endocrinologist and is a member of the Clinical Trials of America’s network of experienced principal investigators. He chooses to practice endocrinology because it provides him with the opportunity to have a positive impact on the lives of his patients.
Contact: Don Dickerson, Clinical Trials of America, Inc., (541) 349-0523, ddickerson@ctofa.com
Monica Shovlin, The Ulum Group, (541) 434-7028, mshovlin@ulum.com
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Dr. Pardini at Clinical Trials of America commented on the study: “We are excited to be involved in this clinical study of a potential new treatment which would intervene in disease progression at the onset of type 1 diabetes. If successful, otelixizumab may offer patients an innovative treatment option, consisting of a single short treatment course that may improve type 1 diabetes disease control.”
About the DEFEND Program
The DEFEND program consists of two Phase 3 studies, DEFEND-1 and DEFEND-2, assessing the safety and efficacy of otelixizumab in new-onset autoimmune type 1 diabetes. The program is designed to evaluate whether a single short course of otelixizumab, a targeted T cell anti-CD3 monoclonal antibody, administered within 90 days after the initial diagnosis of diabetes, will preserve beta cell function as measured by C-peptide. The primary endpoint in both studies is change in C-peptide 12 months after study drug administration. Both studies are being conducted at centers throughout North America and Europe. DEFEND-1 is a randomized, double-blind, placebo-controlled Phase 3 study that completed enrollment of 240 patients, ages 12 to 45, in early 2010. Similar to DEFEND-1 in design, DEFEND-2 seeks to enroll up to approximately 400 patients, ages 12 to 45, within 90 days of diagnosis of diabetes. For more information about the DEFEND program, 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 (beta cells). T lymphocytes called effector T cells mistakenly attack and destroy these insulin-producing beta cells, in the pancreas. The resulting decrease in endogenous (natural) insulin production means that patients must monitor their glucose levels frequently and give themselves insulin by injection or pump to control blood glucose levels.
About Otelixizumab
Otelixizumab is a targeted T cell immunomodulator 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, while stimulating regulatory T cells that are understood to protect against effector T cell damage, thus preserving the beta cells' ability to make insulin. The efficacy and safety of otelixizumab in the treatment of type 1 diabetes is being studied in the DEFEND program. Otelixizumab is being developed in type 1 diabetes by Tolerx (www.tolerx.com) in collaboration with GlaxoSmithKline (www.gsk.com).
About Clinical Trials of America, Inc.
A physician founded and operated clinical trial company, Clinical Trials of America is driven by a team of dedicated, experienced professionals who are passionate about research. Dr Aaron Pardini is a board certified endocrinologist and is a member of the Clinical Trials of America’s network of experienced principal investigators. He chooses to practice endocrinology because it provides him with the opportunity to have a positive impact on the lives of his patients.
Contact: Don Dickerson, Clinical Trials of America, Inc., (541) 349-0523, ddickerson@ctofa.com
Monica Shovlin, The Ulum Group, (541) 434-7028, mshovlin@ulum.com
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Contact
Clinical Trials of America
Monica Shovlin
(541) 434-7028
www.ulum.com
Monica Shovlin
(541) 434-7028
www.ulum.com
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