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Notification report

Full notification file


General information

Notification Number
B/FR/13/GT05

Member State to which the notification was sent
France

Date of acknowledgement from the Member State Competent Authority
02/08/2013

Title of the Project
A phase I/IIa, non randomized, escalating dose, open-label study to evaluate safety and efficacy of GS010 (rAAV2/2-CMV-ND4) in patients suffering from Leber Hereditary Optic Neuropathy due to mutations in the mitochondrial NADH Dehydrogenase 4 gene

Proposed period of release:
01/11/2013 to 30/06/2014

Name of the Institute(s) or Company(ies)
GENETHON, 1 bis rue de l’Internationale
91002 Evry
France;


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:
Parvoviridae
Genus: Dependovirus
Species: AAV-derived replication-deficient vector

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

Common Name	Genus	Species	Subspecies	Strain	Pathovar
AAV2	Dependovirus	Adeno-associated Virus	-	serotype 2	-

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known