Back

Notification report


Full notification file


General information

Notification Number
B/DE/06/PEI231

Member State to which the notification was sent
Germany

Date of acknowledgement from the Member State Competent Authority
21/04/2006

Title of the Project
A Phase IIb Multicentric Controlled Study Evaluating the Therapeutic Vaccine TG4010 (MVA-MUC1-IL2) as an adjunct to Standard Chemotherapy in Advanced Non Small Cell Lung Cancer.

Proposed period of release:
01/12/2005 to 16/06/2008

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


3. Is the same GMO release planned elsewhere in the Community?
Yes:
France; Hungary; Poland;

Has the same GMO been notified elsewhere by the same notifier?
No

GMO characterization

GMO is a:
DNA Virus

Identity of the GMO:
The final genetically modified organism (GMO) is TG4010 and consists of a recombinant vaccinia vector consisting of the modified vaccinia virus Ankara (MVA) genome containing inserted transgenes that encode two proteins: the human mucine 1 (MUC1) and the human interleukin-2 (IL2).

Information relating to the recipient or parental organisms from wich the GMO is derived
Common NameGenusSpeciesSubspeciesStrainPathovar
MVAorthopoxvirusvaccinia virusModified Virus Ankara

European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
15/08/2006 00:00:00
Remarks: