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Notification report


Full notification file


General information

Notification Number
B/ES/14/05

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
23/07/2014

Title of the Project
A Phase 2, Multicenter, Open-label, Singlearm 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 (20120325)

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?
Yes:
Austria; Belgium; Germany; France; United Kingdom; Greece; Italy; Poland;

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

GMO characterization

GMO is a:
RNA 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-JS1 (ECACC Accession Number 01010209)-

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known