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Notification report


Full notification file


General information

Notification Number
B/DE/15/PEI2337

Member State to which the notification was sent
Germany

Date of acknowledgement from the Member State Competent Authority
16/02/2015

Title of the Project
Safety and efficacy of a single subretinal injection of rAAV.hCNGA3 in patients with CNGA3-linked achromatopsia investigated in an exploratory, dose-escalation trial

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

Name of the Institute(s) or Company(ies)
University of Tübingen, Department for Ophthalmology, Schleichstraße 12-16, 72076 Tübingen, Germany;


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:
rAAV.hCNGA3 is a recombinant Adeno-associated Virus (AAV) pseudotyped with AAV8 capsid proteins. It contains about 3140 nucleotide sequence of the hCNGA3 expression cassette flanked by the nucleotides of inverted repeat sequences derived from AAV serotype 2. All native cap and rep sequence of the viral genome have been removed and replaced by the hCNGA3 expression cassette.

Information relating to the recipient or parental organisms from wich the GMO is derived
Common NameGenusSpeciesSubspeciesStrainPathovar
AAVDependovirusAdeno-associated Virus--AAV2/AAV8

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known