Phase 1b and Phase 2a clinical trials with an hIL-10-expressing Lactococcus lactis

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Study title: 
Phase 1b and Phase 2a clinical trials with an hIL-10-expressing Lactococcus lactis
EU record number: 
B/BE/07/BVW1
EudraCT number: 
2008-000967-40
Pharmaceutical study code: 
AG011-MDUC-201
Company / Sponsor: 
ActoGeniX N.V.
Phase: 
II
Treated organism: 
Humans
Indication category: 
Gastrointestinal disorders
Disease: 
Ulcerative colitis
Therapeutic approach: 
anti-inflammatory treatment
Genetic modification: 
Gene coding for the human interleukin-10 (hIL-10)
Method of transfer of nucleic acid of interest: 
Lactococcus lactis strain MG1363
Administered biological material: 
Recombinant Lactococcus lactis D (thy A)
Route of administration: 
Oral and rectal
Locations in Belgium: 
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 + AZ Groeninge + UCL St Luc
Nr of subjects: 
Maximum 120
Foreseen duration: 
3 years
Type of procedure: 
Contained use and Deliberate release
Current status: 
Authorized

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