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Tepluzimab to replace regular insulin injections forever found promising in Indian diabetics

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Thursday, July 8, 2010, 8:56 This news item was posted in Clinical Trials category and has 0 Comments so far.

Teplizumab, a new biotech medicine with a potential to replace daily insulin injection in early-onset diabetes patients is currently undergoing clinical testing in various centres including India.

The experimental drug teplizumab promises to eliminate the painful daily insulin hormone injections for diabetes patients for ever.

Teplizumab, which is being tested in around 100 patients in India, is administered through injection to patients in two 14-day phases.

Initially after the diagnosis of diabetes,teplizumab will be injected for 14 consecutive days. After six months, the drug will again be injected for 14 consecutive days, he said.

Teplizumab trials are done on patients who are having diabetes for past three months, are in the age group of 8-35 years with weight of around 36 kg and are not infected from other diseases like tuberculosis.

“The results of the trials seem to be quite promising. It could eliminate the need of insulin injections forever among people suffering from type I and type II diabetes,” stated Dinesh Kumar Dhanwal, the professor of medicine and endocrinologistat the Maulana Azad Medical College and the Lok Nayak Jai Prakash Narayan Hospital, who carries out the trial in India.

The teplizumab trials in India, which have started in India, are approved by Drug Controller General of India (DCGI) and the ethics committee of the hospitals. The trials are expected to be completed by mid-July.

Teplizumab, also called MGA031, is a humanized, non-Fc receptor binding, anti-CD3 monoclonal antibody.

Teplizumab binds to an epitope of the CD3- epsilon chain expressed on mature T lymphocytes and, by doing so, may modulate the pathological immunologic responses underlying multiple autoimmune diseases.

Specifically, teplizumab may inhibit unwanted effector T cells and enhances beneficial regulatory T cell functions, thus promoting immune tolerance.

The currently ongoing PROTEGE trial is a global, pivotal Phase II/III clinical trial study to evaluate the safety and efficacy of three teplizumab dosing regimens administered at the start of the study and again at six months in individuals with recent-onset type 1 diabetes ages 8 to 35 who are up to 12 weeks from their diagnosis.

Type 1 diabetes is an autoimmune disease in which the body’s immune system attacks and destroys the insulin-producing beta cells of the pancreas.

Researchers believe teplizumab may control the T lymphocytes that mediate destruction of the insulin-producing beta cells of the islets of the pancreas. In doing so, they believe teplizumab may have the ability to preserve and protect the remaining beta cells of the pancreas.

The Protégé Encore study will further evaluate the safety of the study drug and test whether it will stop or slow the progression of the autoimmune disease that damages beta cells.

Our bodies use a type of white blood cells, called T cells, to attack cells and germs that are foreign to the body. In people with type 1 diabetes, the body acts as if the insulin-producing beta cells in the pancreas are foreign and allow certain T cells to attack the beta cells.

To slow the effects of type 1 diabetes, the beta cells need a way to protect themselves from the body’s attack. The Protégé Encore study is testing an investigational study drug, a monoclonal antibody, to see if it will protect the beta cells. The study drug may protect beta cells by attaching to T cells before the T cells can attack the beta cells.

India currently has the highest number of 50.8 million people suffering from diabetes, according to the International Diabetes Federation. By 2030, over 8.4 percent of the Indian adult population will suffer from diabetes.

Type 1 diabetes is an autoimmune disease in which the body’s immune system attacks and destroys the insulin-producing beta cells of the pancreas.

The symptoms associated with type 1 diabetes can appear suddenly and leave a person dependent on injected insulin for life. The disease carries the constant threat of devastating complications such as heart and kidney disease, nerve damage and blindness.

Although diagnosis most often occurs in childhood and adolescence, the disease can strike adults as well. Individuals with type 1 diabetes must test their blood sugar four or more times per day and take multiple insulin injections daily or continually infuse insulin through a pump.

While trying to balance insulin doses with their food intake and daily activities, people with this form of diabetes must always be prepared for serious hypoglycemic (low blood sugar) and hyperglycemic (high blood sugar) reactions, both of which impact quality of life and can be life threatening. This balance is especially difficult to achieve in children and young adults who are very active physically.

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