28 May, 2010

Type 1 - Recent advances (Otelixizumab) !!

Otelixizumab, also known as TRX4, is a novel monoclonal antibody, which is being developed for the treatment of type 1 diabetes and other autoimmune diseases. The antibody is being developed by Tolerx, Inc. in collaboration with GlaxoSmithKline and is being manufactured by Abbott Laboratories.

As a monoclonal antibody, otelixizumab consists of two heavy chains and two light chains. The heavy chains are humanized γ1 (gamma-1) chains from rats, making otelixizumab an immunoglobulin G1. The light chains are chimeric human/rat λ (lambda) chains.

Mechanism of action

Otelixizumab is one of several investigational monoclonal antibodies that target CD3, a T lymphocyte receptor involved in normal cell signaling. More specifically, otelixizumab targets the epsilon chain of CD3. Data suggest that the drug 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 preserving the beta cells' normal ability to make insulin.

Clinical progress

The efficacy and safety of otelixizumab for the treatment of autoimmune type 1 diabetes is currently being studied in a pivotal Phase 3 study called DEFEND (Durable-response therapy Evaluation For Early or New-onset type 1 Diabetes). DEFEND is a randomized, placebo-controlled Phase 3 trial designed to enroll approximately 240 adult patients, age 18 to 35, with newly diagnosed autoimmune type 1 diabetes. DEFEND is being conducted at multiple centers in North America and Europe. The trial is designed to evaluate whether a single course of otelixizumab, administered not more than 90 days after the initial diagnosis, will reduce the amount of administered insulin required to control blood glucose levels by inhibiting the destruction of beta cells.

Orphan drug status

Otelixizumab has been granted Orphan Drug Status by the U.S. Food and Drug Administration.

Now whats orphan drug status???

An orphan drug is a pharmaceutical agent that has been developed specifically to treat a rare medical condition, the condition itself being referred to as an orphan disease. The assignment of orphan status to a disease and to any drugs developed to treat it is a matter of public policy in many countries, and has resulted in medical breakthroughs that may not have otherwise been achieved due to the economics of drug research and development.


  1. This Drug is effective only if there is some beta cell reserve in the body and only if are known to have some autoantibody. Otherwise no use.This has created an excitement in the type 1 children, which actually might not be useful unless they have a significant c peptide level.Pts having a subnormal reserve of insulin can also be tried on this drug as there are other benefits in retaining the existing B-cells.Let See.....

  2. thank you madam.. ur inputs are really helpful. i will try to post few topics which a common man needs to know...

  3. why is it not allowed for diabetic patients to take their diabetic tablets ahead of a cataract surgery?
    Here is my webpage :: diabetic meal plan

    1. well it depends on your sugar levels... some patients tend to develop hypoglycemia in post op period.. hypo in recently operated eye is not good. so we generally avoid tablets but that is not a hard and fast rule...


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