The FPS Public Health and the FAMHP invite you to participate in the public consultation on a clinical trial with the genetically modified medicinal product AG019 from the company Intrexon T1D Partners, LLC (IT1D). The purpose of this trial is to evaluate the safety, tolerability and potential activity of AG019, alone or in combination with teplizumab, for the treatment of diabetes mellitus type 1. The public consultation runs from 25 June 2018 to 25 July 2018 inclusive.
In the clinical trial, the strain MG1363 of the bacteria Lactococcus lactis has been genetically modified to produce therapeutic proteins (human interleukin-10 and human proinsulin). These proteins are expected to stop the autoimmune destruction of pancreatic cells of patients recently diagnosed with type 1 diabetes mellitus (T1D). The medicinal product AG019 is based on these genetically modified bacteria and is administered orally as capsules.
This trial consists of two phases.
- In the first phase of the trial the safety and tolerability of different doses of AG019 are investigated in patients recently diagnosed with T1D.
- In the second phase of the trial the safety and tolerability of different doses of AG019, combined with infusions of another medicinal product under development called teplizumab, are investigated in patients recently diagnosed with T1D.
The clinical trial will be conducted at the University Hospital in Leuven, the University Hospital in Antwerp and the University Hospital in Brussels.
As a citizen of Belgium you can comment on this clinical trial application.
For each clinical trial application related to the use of genetically modified organisms, the authority organises a public consultation for thirty days (in accordance with the Royal Decree of 21 February 2005).
You will have access to the data in the application file, as well as to an on-line form (see Dutch or French) to send comments or ask questions about this file.
The public consultation will last until 25 July 2018 inclusive.
General information on GMOs and public consultation (see Dutch or French).