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Notification report


Full notification file


General information

Notification Number
B/DE/10/PEI1035

Member State to which the notification was sent
Germany

Date of acknowledgement from the Member State Competent Authority
15/02/2010

Title of the Project
A phase II randomized, multicenter, open-label study of TG4040 (MVA-HCV) in combination with pegylated interferon alfa-2a and ribavirin versus pegylated interferon alfa-2a and ribavirin in treatment-naïve patients with chronic genotype 1 hepatitis C

Proposed period of release:
01/05/2010 to 31/03/2013

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; Poland; Romania;

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 GMO is TG4040 and consists of recombinant MVA vector particles (MVATG16643) in suspension in a formulation solution. MVATG16643 is a non integrative, poorly replicative, non propagative, recombinant vaccinia vector consisting of the modified vaccinia virus of Ankara (MVA) genome containing nucleotide sequences encoding Hepatitis C virus (HCV) non structural proteins NS3, NS4 and NS5B.

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
27/07/2010 00:00:00
Remarks: