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Notification report


Full notification file


General information

Notification Number
B/ES/13/18

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
12/03/2013

Title of the Project
Phase I Clinical Trial of Delta-24-RGD oncolytic adenovirus and
temozolomide for treatment of glioblastoma at first recurrence


Proposed period of release:
01/04/2013 to 01/04/2015

Name of the Institute(s) or Company(ies)
ClĂ­nica Universidad de Navarra, ;


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

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

GMO characterization

GMO is a:
DNA Virus

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

The GMO (Delta24-RGD-4C) is an oncolytic adenovirus, which is a replication competent virus selective of tumoral cells. Its genome contains 2 genetic modifications with respect to the wildtypevirus (Ad5).


Information relating to the recipient or parental organisms from wich the GMO is derived
Common NameGenusSpeciesSubspeciesStrainPathovar
Adenovirus human serotype 5 (Ad5)Mastadenovirushuman adenovirussubgroup Chuman serotype 5 (Ad5)-

European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
17/05/2013 00:00:00
Remarks: