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Notification report

Full notification file


General information

Notification Number
B/ES/12/39

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
09/04/2012

Title of the Project
A Phase 1/2a Dose-Escalation Study of JX-594 (Thymidine Kinase-Deactivated Vaccinia Virus plus GM-CSF) Administered by Multiple Intravenous (IV) Infusions Followed by Intratumoral (IT) Boosts Alone and in Combination with Irinotecan in Patients with Metastatic, Refractory Colorectal Carcinoma

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:
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
vaccinia virus	orthopoxvirus	vaccinia virus	-	Wyeth	-

European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
18/06/2012 00:00:00
Remarks: