B/BE/07/BVW1
| Company/Institution | ActoGeniX N.V. |
| Parental organism | Lactococcus lactis strain MG1363 |
| Transgene(s) | Gene coding for the human interleukin-10 (hIL-10) |
| Treated organism | Humans |
| Title of the project | Phase 1b and Phase 2a clinical trials with an hIL-10-expressing Lactococcus lactis |
| Treatment indication | Moderately active ulcerative colitis |
| Administration route(s) | Oral and rectal |
| Total number of subjects foreseen | Maximum 120 |
| Foreseen duration of release | 3 years |
| Effective year(s) of release | |
| Current status | Authorized - trial running |
| Locations | Flanders, Wallonia and Brussels as a consequence of clinical trials conducted with patients from all the country recruited at UZ Gasthuisberg (Leuven), Imelda vzw (Bonheiden), UZ Antwerpen and UZ Gent + notification of 2 additional locations |
| Number of sites | 6 in Belgium |
| Monitoring | |
| Type of procedure | Standard procedure - Chapter II Royal Decree 21 February 2005 |
| Notes | |
| Other |
Information for the public
-
B/BE/07/BVW1 - Summary Notification Information Format (SNIF)
Public information presented according to the provisions of Directive 2001/18/EC
- B/BE/07/BVW1 - Public information sheet (written by the notifier)
- B/BE/07/BVW1 - Fiche d'information destinée au public (préparée par le notifiant)
- B/BE/07/BVW1 – Informatie fiche bestemd voor het publiek (voorbereid door de kennisgever)
Information related to the decision procedure
-
B/BE/07/BVW1 - Advice Biosafety Advisory Council
18 January 2008: The Biosafety Advisory Council issues a positive advice (with conditions) for this trial.
-
B/BE/07/BVW1 - Decision of the Federal Minister (FINAL DECISION)
04 February 2008: The Federal Ministers give a final decision (positive) for this trial.
