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

Phase

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

Pharmaceutical study code

AG011-MDUC-201

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.