The Australian Type 1 Diabetes Clinical Research Network has partnered with the Immune Tolerance Network to launch a new Australian clinical trial to slow the development of newly diagnosed type 1 diabetes in children.
The EXTEND-P trial is expected to begin recruitment in March 2016 to test the ability of an existing drug called tocilizumab to preserve beta cell function. Tocilizumab, sold under the brand name Actemra, is currently approved for use in children with juvenile arthritis.
Children aged between 6 and 17 years of age who are within 100 days of diagnosis will be randomly allocated to a placebo or treatment group. Both groups will receive seven intravenous infusions of either tocilizumab or an inactive substance over a 24 week period. Insulin production will be analysed over the following 18 months as a measure of beta cell function in both groups.
Tocilizumab works by blocking the action of interleukin-6 (IL-6), an immune regulating protein that promotes inflammation. IL-6 has been implicated in a number of autoimmune diseases including type 1 diabetes (T1D). By blocking IL-6 mediated inflammation, tocilizumab may preserve the function of the remaining healthy beta cells at the time of T1D diagnosis.
This is a world first for paediatric use of this drug in T1D – the international EXTEND trial is studying the use of tocilizumab in adults with T1D. The target for patient recruitment is 66, initially across NSW and QLD with further scope to extend to other sites. The trial will be launched with $5 million in funding, jointly supplied by the Immune Tolerance Network (ITN) and JDRF Australia’s Type 1 Diabetes Clinical Research Network, funded by the Australian Research Council.
The ITN is an international clinical research consortium funded by National Institute of Allergy and Infectious Diseases, part of the United States’ National Institutes of Health. Their mission is to accelerate the clinical development of immune tolerance therapies targeting a range of autoimmune conditions including T1D. The ITN has also recently published the results of their study looking at repurposing the psoriasis drug alefacept for beta cell preservation in T1D.
Mike Wilson said the EXTEND-P trial was another great example of research being brought into day to day life. “If this existing drug can be proven to slow the development of type 1 diabetes in children, it will be life-changing, giving them a huge head-start in managing this disease.”
Watch the 7 news story broadcast on 15th October, 2015.
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