The FPS Health and the FAMHP invite you to participate in the public consultation on a clinical trial with the genetically modified medicinal product Talimogene Laherparepvec. The purpose of this trial is to determine the safety and efficacy of Talimogene Laherparepvec in pediatric subjects with advanced non-central nervous system (CNS) tumors that are amenable to direct injection. The public consultation runs from 24 March to 24 April 2019 inclusive.
In this clinical trial, Talimogene Laherparepvec from the company Amgen is administered, a modified herpes simplex virus (HSV) type-1 (‘cold-sores’ virus), to which the so called human GM-CSF medicine has been added. Human GM-CSF is used to treat patients in which the white blood cells count is too low.
Talimogene Laherparepvec is administered by direct injection with a needle in one or more tumor(s). The medicine has been developed with dual mechanisms of action. It destroys the cells in the tumor in which it has been injected, and it enhances the cells of the body’s immune system that fight to destroy the tumor cells that have circulated in other parts of the body, at distance of the injection site. The initial version (the ‘wild type’) of HSV type-1 can cause a variety of symptoms, such as cold sores. However, due the modifications that were made to Talimogene Laherparepvec, it is unlikely that it will cause these symptoms.
The clinical trial will be conducted at the University Hospital in Gent.
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) (in Dutch and French) to send comments or ask questions about this file.
The public consultation will last until 24 April 2019 inclusive.
General information on GMOs and public consultation (HTML) (in Dutch and French)