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Notification report

Full notification file


General information

Notification Number
B/FR/15/GT03

Member State to which the notification was sent
France

Date of acknowledgement from the Member State Competent Authority
31/12/2014

Title of the Project
The clinical study to be conducted with JX-594 is entitled:
“A phase Ib/II study of metronomic cyclophosphamide and the oncolytic poxvirus JX-594 in
patients with advanced breast cancer and advanced soft tissue sarcoma”. The clinical study
short title is METROmaJX.

Proposed period of release:
01/11/2014 to 01/11/2017

Name of the Institute(s) or Company(ies)
Institut Bergonié, Centre Régional de Lutte contre le Cancer de Bordeaux
et du Sud-Ouest
229 cours de l’Argonne
33076 Bordeaux Cedex
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)

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:
Not known