Give your opinion on a clinical trial with a genetically modified medicinal product in Pediatric Subjects With Advanced Noncentral Nervous System Tumors That are Amenable to Direct Injection.

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 from the company Amgen. 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 is administered, a modified herpes simplex virus (HSV) type-1 (‘cold-sores’ virus), to which a medicine called human granulocyte macrophage colony stimulating factor (GM-CSF), has been added. Human GM-CSF is a medicine that 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). Talimogene laherparepvec 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 Talimogene laherparepvec will cause these symptoms.

The purpose of this clinical trial is to determine the safety and tolerability of talimogene laherparepvec, as assessed by incidence of dose-limiting toxicities (DLT), in pediatric subjects with advanced non-central nervous system tumors that are amenable to direct injection.

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 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

 

 

Last updated on
24/03/2019