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
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?

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

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:
14/12/2015 00:00:00