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Notification report


Full notification file


General information

Notification Number
B/BE/18/BVW5

Member State to which the notification was sent
Belgium

Date of acknowledgement from the Member State Competent Authority
20/06/2018

Title of the Project
A prospective, multi-center, Phase 1b/2a study to assess the safety and tolerability of different doses of AG019 administered alone or in association with teplizumab in subjects with clinical recent-onset Type 1 Diabetes Mellitus (T1D).

Proposed period of release:
01/08/2018 to 31/08/2019

Name of the Institute(s) or Company(ies)
Intrexon T1D Partners, LLC, ;


3. Is the same GMO release planned elsewhere in the Community?
No

Has the same GMO been notified elsewhere by the same notifier?
No

GMO characterization

GMO is a:
Bacterium

Identity of the GMO:
Lactococcus lactis

Information relating to the recipient or parental organisms from wich the GMO is derived
Common NameGenusSpeciesSubspeciesStrainPathovar
-LactococcusL. LactiscremorisMG1363-

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known