B/BE/03/B3

Company/Institution	Transgene S.A.
Parental organism	Human adenovirus C serotype 5 deleted in E1 and E3
Transgene(s)	gene coding for human interleukin 2
Treated organism	Humans
Title of the project	Phase I multicentre study of TG1024 (Adenovirus interleukin 2) in patients with metastatic melanoma or other advanced solid tumor cancers
Treatment indication	metastatic melanoma or other advanced solid tumor cancers
Administration route(s)	intratumoral
Total number of subjects foreseen	not specified (up to 51 patients in Switzerland and Belgium)
Foreseen duration of release	about 12 months
Effective year(s) of release	1 year
Current status	Trial completed
Locations	Erasme Hospital, Brussels
Number of sites	1
Monitoring	Control of the presence of the GMO in blood, tonsils, urines, and feces from the human patients infected with the GMO
Type of procedure	Classical procedure - Art. 9§1 of Royal Decree of 18 December 1998
Notes	In June 2004 the notifier sent additional data and made a request to alleviate one of the conditions of the authorization. As a result of this request, a revised advice was drafted by the Biosafety Advisory Council and a second authorization was delivered by the Competent Authority.
Other

Information for the public

B/BE/03/N3 - Advice Biosafety Advisory Council
26 March 2004 & 5 July 2004: The Biosafety Advisory Council issues a positive advice (with conditions) for this trial.
26 March 2004 - Scientific report of the group of experts mandated by the Biosafety Advisory Council
B/BE/03/B3 - Decision of the Federal Public Service (FINAL DECISION)
29 April 2004 & 8 July 2004: The Federal Public Service Health, Food chain safety and Environment gives a final decision (positive) for this trial.