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 1/2 Ascending Dose Study to Evaluate the Safety and Effects on Progranulin Levels of PR006 in Patients with Fronto-Temporal Dementia with Progranulin Mutations (FTD-GRN).

Proposed period of release:
01/03/2021 to 30/09/2027

Name of the Institute(s) or Company(ies)
Prevail Therapeutics, Inc., 430 East 29th Street, Suite 1520
New York, NY 10016

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

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

If yes, notification number(s):

GMO characterization

GMO is a:
DNA Virus

Identity of the GMO:
Genus: Dependoparvovirus
Species: Recombinant AAV9

Information relating to the recipient or parental organisms from wich the GMO is derived
Common NameGenusSpeciesSubspeciesStrainPathovar
-DependoparvovirusAdeno-associated Virus-AAV9-

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known