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Notification report


Full notification file


General information

Notification Number
B/FR/16/GT03

Member State to which the notification was sent
France

Date of acknowledgement from the Member State Competent Authority
28/07/2016

Title of the Project
The clinical study to be conducted with TG6002 is entitled: “Safety and efficacy of the ONCOlytic VIRus Armed for local Chemotherapy, TG6002/5-FC, in recurrent glioblastoma patients”. The clinical study short title is ONCOVIRAC.

Proposed period of release:
31/03/2017 to 30/06/2021

Name of the Institute(s) or Company(ies)
Assistance Publique Hôpitaux de Paris, ;


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:
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 and 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
vaccine virusOrthopoxvirusvaccinia-Copenhagen-

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known