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Notification report


Full notification file


General information

Notification Number
B/DE/15/PEI2422

Member State to which the notification was sent
Germany

Date of acknowledgement from the Member State Competent Authority
21/05/2015

Title of the Project
THOR - Tübingen Choroideremia gene therapy trial open label Phase 2 clinical trial using an adeno-associated viral vector (AAV2) encoding Rab-escort protein 1 (REP1)

Proposed period of release:
29/07/2015 to 29/10/2015

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:
The rAAV2.REP1 product consists of a purified recombinant serotype 2 adeno-associated viral vectors (rAAV) encoding the cDNA of human Rab escort protein type 1 (REP1).

Genus: Dependovirus
Species: Adeno-associated virus


Information relating to the recipient or parental organisms from wich the GMO is derived
Common NameGenusSpeciesSubspeciesStrainPathovar
AAV2DependovirusAdeno-associated Virus--AAV2

European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
14/12/2015 00:00:00
Remarks: