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Notification report

Full notification file


General information

Notification Number
B/ES/14/08

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
06/11/2014

Title of the Project
A Phase 2, Multicenter, Randomized, Openlabel Trial Assessing the Efficacy and Safety of Talimogene Laherparepvec Neoadjuvant Treatment Plus Surgery Versus Surgery Alone for Resectable, Stage IIIB to IVM1a Melanoma (20110266)

Proposed period of release:
01/03/2015 to 31/12/2016

Name of the Institute(s) or Company(ies)
Amgen Limited, UK, On behalf of Amgen Inc. (study sponsor);


3. Is the same GMO release planned elsewhere in the Community?
Yes:
France; Greece; Poland;

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

If yes, notification number(s):


GMO characterization

GMO is a:
DNA Virus

Identity of the GMO:
Genus: Simplexvirus
Species: Talimogene laherparepvec is a recombinant of a wild-type Herpes simplex virus 1 (HSV-1) strain JS1, with genes ICP34.5 and ICP47 deleted and hGM-CSF inserted

Information relating to the recipient or parental organisms from wich the GMO is derived

Common Name	Genus	Species	Subspecies	Strain	Pathovar
HSV-1	Simplexvirus	Herpes simplex virus	-	JS1 (ECACC Accession Number 01010209)	-

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known