Notification report

Full notification file

General information

Notification Number

Member State to which the notification was sent

Date of acknowledgement from the Member State Competent Authority

Title of the Project
A Phase 2, Multicenter, Open-label, Single-arm Trial to Evaluate the Correlation Between Objective Response Rate and Baseline Intratumoral CD8+ Cell Density in Subjects With Unresected Stage IIIB to IVM1c Melanoma Treated with Talimogene Laherparepvec

Proposed period of release:
01/12/2014 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?
Austria; Belgium; Spain; France; United Kingdom; Greece; Italy; Poland;

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

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 NameGenusSpeciesSubspeciesStrainPathovar
HSV-1SimplexvirusHerpes simplex virus 1 (HSV-1)-JS1 (ECACC Accession Number 01010209)-

European Commission administrative information

Consent given by the Member State Competent Authority:
12/03/2015 00:00:00