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Notification report

Full notification file


General information

Notification Number
B/HU/15/01

Member State to which the notification was sent
Hungary

Date of acknowledgement from the Member State Competent Authority
26/02/2015

Title of the Project
The project, TG4010.14 clinical trial, is entitled “A Phase IIb/III randomized, double blind, placebo controlled, study comparing first line therapy with or without the therapeutic vaccine TG4010 in patients with stage IV non small cell lung cancer (NSCLC)

Proposed period of release:
01/12/2011 to 30/09/2019

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


3. Is the same GMO release planned elsewhere in the Community?
Yes:
Belgium; Germany; Spain; France; United Kingdom; Italy; 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 non replicative, 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 Name	Genus	Species	Subspecies	Strain	Pathovar
MVA	orthopoxvirus	vaccinia virus	-	Modified vaccinia virus Ankara	-

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known