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 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

3. Is the same GMO release planned elsewhere in the Community?

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)

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:
Not known