B/BE/03/B3 - Summary Notification Information Format (SNIF)Public information presented according to the provisions of Directive 2001/18/EC
EU record number
B/BE/03/B3
Company / Sponsor
Transgene S.A.
Treated organism
Humans
Indication category
Cancer therapy
Disease
Metastatic melanoma or other advanced solid tumors
Therapeutic approach
Immunotherapy
Genetic modification
gene coding for human interleukin 2
Method of transfer of nucleic acid of interest
Human adenovirus C serotype 5 deleted in E1 and E3
Administered biological material
Recombinant Adenovirus D (E1, E3)
Route of administration
intratumoral
Locations in Belgium
Erasme Hospital, Brussels
Nr of subjects
not specified (up to 51 patients in Switzerland and Belgium)
Foreseen duration
about 12 months
Type of procedure
Contained use and Deliberate release
Current status
Authorized
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.
Pharmaceutical study code
TG1024.01