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Notification report


Full notification file


General information

Notification Number
B/ES/18/15

Member State to which the notification was sent
Spain

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

Title of the Project
A Phase I/IIa study of TG6002 (VV TK-RR-FCU1) administered by intravenous (IV) infusions in combination with oral flucytosine (5-FC) in patients with advanced gastro-intestinal (GI) tumors.
The clinical study code is TG6002.02.


Proposed period of release:
01/10/2018 to 31/07/2021

Name of the Institute(s) or Company(ies)
Transgene SA, 400 Boulevard Gonthier d’Andernach
Parc d’Innovation
CS80166
67405 Illkirch Graffenstaden cedex - France;


3. Is the same GMO release planned elsewhere in the Community?
Yes:
Belgium; Germany; France;

Has the same GMO been notified elsewhere by the same notifier?
Yes

If yes, notification number(s):
B/BE/18/BVW1;

GMO characterization

GMO is a:
DNA Virus

Identity of the GMO:
Genus: Orthopoxvirus
Species: Vaccinia virus (VV)

The GMO is a viral suspension of the recombinant virus TG6002. TG6002 is a non-integrative, conditionally replicative, recombinant VV derived from the Copenhagen strain. TG6002 differs by three genetic modifications from the Copenhagen strain:
1) deletion of the viral thymidine kinase (TK) gene
2) deletion of the viral ribonucleotide reductase (RR) gene
3) insertion of the chimeric yeast FCU1 suicide gene in the TK locus


Information relating to the recipient or parental organisms from wich the GMO is derived
Common NameGenusSpeciesSubspeciesStrainPathovar
vaccinia virusOrthopoxvirusVaccinia virus-Copenhagen-

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known