The FPS Health and the FAMHP invite you to participate in the public consultation on a clinical trial with the genetically modified medicinal product AG013 from the company Oragenics. The purpose of this trial is to evaluate the safety and efficacy of AG013 for the attenuation of oral mucositis in patients with cancer of the head and neck receiving concomitant chemoradiation therapy. The public consultation runs from 18 June to 18 July 2018 inclusive.

The purpose of this clinical trial is to reduce the signs and the symptoms of oral mucositis, being a side effect to radiotherapy and/or chemotherapy. Subjects with oral mucositis get soreness, irritation, and ulcers in the mouth and may have a hard time eating, drinking or swallowing as a result of their cancer treatment.

In the clinical trial, AG013 will be administered to the cancer patients as a mouth rinse. AG013 is a formulation of the genetically modified (GM) L. lactis strain sAGX0085. 

The clinical trial will be conducted at the University Hospital in Leuven, the University Hospital in Brussels, the Jules Bordet Institute in Brussels, the Grand Hospital in Charleroi, the University Hospital in Antwerp and the General Hospital Sint-Maarten in Duffel.

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 30 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 (HTML) to send comments or ask questions about this file.

The public consultation will last until 18 July 2018 inclusive.

General information on GMO's and public consultation (HTML)