Notification report

Full notification file

General information

Notification Number

Member State to which the notification was sent

Date of acknowledgement from the Member State Competent Authority

Title of the Project
The project, JX594-HEP018 clinical trial, is entitled “A Phase 2b Randomized, Open-Label Trial of JX-594 (Vaccinia GM-CSF / TK-deactivated Virus) Plus Best Supportive Care Versus Best Supportive Care in Patients with Advanced Hepatocellular Carcinoma Who Have Failed Sorafenib Treatment (JX594-HEP018)”

Proposed period of release:
01/04/2012 to 31/08/2013

Name of the Institute(s) or Company(ies)
Transgene S.A., ;

3. Is the same GMO release planned elsewhere in the Community?
Germany; Spain; Italy;

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

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
-orthopoxvirusvaccinia virus-Wyeth-

European Commission administrative information

Consent given by the Member State Competent Authority:
21/06/2012 00:00:00