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Notification report

Full notification file


General information

Notification Number
B/FR/12/GT05

Member State to which the notification was sent
France

Date of acknowledgement from the Member State Competent Authority
17/10/2012

Title of the Project
A Single-Arm, Open-Label Phase 2 Study of JX 594 (Thymidine Kinase-Deactivated Vaccinia Virus plus GM-CSF) Administered by Weekly Intravenous (IV) Infusions in Sorafenib-naïve Patients with Advanced Hepatocellular Carcinoma (HCC).

Proposed period of release:
01/08/2012 to 31/08/2014

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


3. Is the same GMO release planned elsewhere in the Community?
Yes:
Spain; France; United Kingdom;

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
-	Orthopox virus	vaccinia virus	-	Wyeth	-

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known