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 I/II, open‐label, study of intracerebral administration of adeno‐associated viral vector containing the human alpha‐N‐acetylglucosaminidase gene for the treatment of Sanfilippo type B syndrome

Proposed period of release:
01/04/2013 to 30/09/2013

Name of the Institute(s) or Company(ies)
Institut Pasteur, ;

3. Is the same GMO release planned elsewhere in the Community?

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

GMO characterization

GMO is a:
DNA Virus

Identity of the GMO:
AAV2.5‐hNaGlu is an Adeno‐Associated Virus serotypes 2 and 5 carrying the human alpha‐N‐acetylglucosaminidase gene.
Genus: Dependovirus
Family: Parvoviridae

Information relating to the recipient or parental organisms from wich the GMO is derived
Common NameGenusSpeciesSubspeciesStrainPathovar
Adeno-associated virusDependovirusAdeno‐Associated VirusParvoviridae/ParvoviriaeN/AN/A

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known