B/BE/11/BVW1

Company/Institution	Transgene
Parental organism	modified Vaccinia virus Ankara (MVA)
Transgene(s)	sequences coding for human mucine 1 (MUC1) antigen and interleukin-2 (IL2)
Treated organism	Humans
Title of the project	A Phase IIb/III randomized, double-blind, placebo-controlled study comparing first-line therapy with or without TG4010 immunotherapy product in patients with stage IV non-small cell lung cancer (NSCLC)
Treatment indication	immunotherapy in patients suffering stage IV non-small cell lung cancer (NSCLC)
Administration route(s)	subcutaneous
Total number of subjects foreseen	1018 worlwide - 30 patients foreseen in Belgium
Foreseen duration of release	4 years
Effective year(s) of release
Current status	Advice of the Belgian Biosafety Advisory Council dated 30/09/2011 - Dossier waiting authorization from the competent authority.
Locations	Antwerpen, Libramont, Liège
Number of sites	65 sites worldwide - 4 sites foreseen in Belgium: C. H. U. Sart-Tilman (Liège), C. H. R. de la Citadelle (Liège), ZNA Middelheim (Antwerpen), Centre Hospitalier de l'Ardenne (Libramont)
Monitoring
Type of procedure	Notification for deliberate release of GMO's other than higher plants for any other purpose than for placing on the market - submitted under the Royal Decree of 21 February 2005 on Deliberate release of genetically modified organisms - part B
Notes
Other

Information for the public

B/BE/11/BVW1 - Advice Biosafety Advisory Council
30 September 2011 : The Biosafety Advisory Council issues a positive advice (with conditions) for this trial.
B/BE/11/BVW1 - Decision of the Federal Minister (FINAL DECISION)
21/11/2011: The Federal Minister gives a final decision (positive) for this trial.