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Notification report


Full notification file


General information

Notification Number
B/DE/16/PEI2516

Member State to which the notification was sent
Germany

Date of acknowledgement from the Member State Competent Authority
21/08/2015

Title of the Project
VXM01 phase I pilot study in patients with operable recurrence of a glioblastoma to examine safety, tolerability, immune and biomarker response to the investigational VEGFR-2 DNA vaccine VXM01 (Study Code VXM01-02-DE)

Proposed period of release:
01/12/2015 to 31/07/2017

Name of the Institute(s) or Company(ies)
VAXIMM GmbH, MAFINEX-Technologiezentrum
Julius-Hatry-Stra├če 1
68163 Mannheim;


3. Is the same GMO release planned elsewhere in the Community?
Yes:
Germany;

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

GMO characterization

GMO is a:
Bacterium

Identity of the GMO:
Salmonella enterica serovar Typhi Ty21a (carrying a plasmid with an eukaryotic expression cassette encoding human vascular endothelial growth factor receptor 2)

Information relating to the recipient or parental organisms from wich the GMO is derived
Common NameGenusSpeciesSubspeciesStrainPathovar
S.typhi Ty21aEnterobacteriaceaesalmonellaentericaTy21aSerotype Typhi

European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
18/01/2016 00:00:00
Remarks: