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Notification report


Full notification file


General information

Notification Number
B/ES/16/05

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
29/04/2016

Title of the Project
Phase II randomized trial of DNX-2401 oncolytic adenovirus added to standard of care for newly diagnosed glioblastoma

Proposed period of release:
01/09/2016 to 01/09/2018

Name of the Institute(s) or Company(ies)
Universidad de Navarra, Neurología-Neurociencias Clínica
Universitaria, Avenida de Pío XII, 36, Facultad de Medicina (Pamplona, España);


3. Is the same GMO release planned elsewhere in the Community?
No

Has the same GMO been notified elsewhere by the same notifier?
Yes

If yes, notification number(s):
B/ES/13/18;

GMO characterization

GMO is a:
DNA Virus

Identity of the GMO:
Genus: Mastadenovirus
Species: human adenovirus


Information relating to the recipient or parental organisms from wich the GMO is derived
Common NameGenusSpeciesSubspeciesStrainPathovar
Human adenovirus type 5Mastadenovirushuman adenovirussubgroup Chuman serotype 5-

European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
21/06/2016 00:00:00
Remarks: