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Notification report

Full notification file


General information

Notification Number
B/DE/11/PEI1491

Member State to which the notification was sent
Germany

Date of acknowledgement from the Member State Competent Authority
08/11/2011

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?
Yes:
Germany; Spain; Italy;

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 Name	Genus	Species	Subspecies	Strain	Pathovar
-	orthopoxvirus	vaccinia virus	-	Wyeth	-

European Commission administrative information

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