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Notification report


Full notification file


General information

Notification Number
B/FR/16/GT02

Member State to which the notification was sent
France

Date of acknowledgement from the Member State Competent Authority
07/03/2016

Title of the Project
ISI-JX - A Phase I trial evaluating the impact of an in situ Immunization strategy with Intra-Tumoral Injections of Pexa-Vec in combination with ipilimumab in advanced solid tumors with injectable lesions

Proposed period of release:
01/07/2016 to 30/09/2019

Name of the Institute(s) or Company(ies)
Centre Léon Bérard, Centre Régional de Lutte contre le Cancer
28 rue Laënnec
69008 Lyon
France;


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 JX-594. JX-594 is a non-integrative, replicative, propagative, recombinant VV derived from the commonly used commercial vaccine Wyeth strain. JX-594 differs by three genetic modifications from the wild type Wyeth strain: 1) disruption of the viral thymidine kinase (TK) gene by, 2) insertion of the human granulocyte macrophage-colony stimulating factor (hGM-CSF) gene and 3) insertion of the lacZ gene.


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

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known