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Notification report


Full notification file


General information

Notification Number
B/ES/12/35

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
20/05/2012

Title of the Project
Phase I, multicentre, open label, single dose, dose-ranging clinical trial to investigate the safety and tolerability of a gene therapy vector rAAV2/5-PBGD for the treatment of Acute Intermittent Porphyria.

Proposed period of release:
01/08/2012 to 31/12/2013

Name of the Institute(s) or Company(ies)
Digna Biotech SL, Avda. Pio XII, 22 - Oficina 2
31008 Pamplona (Navarra);


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:
Parvoviridae
Genus: Dependovirus
Species: AAV-derived replication-deficient vector
The complete name of the selected recombinant vector is rAAV2/5.2-Ealb-hAAT-cohPBGDpolyA PBGD, also shortly named rAAV2/5-PBGD and coded as AMT-021 by the manufacturer.


Information relating to the recipient or parental organisms from wich the GMO is derived
Common NameGenusSpeciesSubspeciesStrainPathovar
-DependovirusAdeno-associated Virus-Serotypes 2 and 5AAV2 and AAV5

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known