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 3, Open-Label, Randomized, Parallel Group Study to Evaluate the Efficacy and Safety of Intrapleural Administration of Adenovirus-Delivered Interferon Alpha-2b (rAd-IFN) in Combination with Celecoxib and Gemcitabine in Patients with Malignant Pleural Mesothelioma

Proposed period of release:
01/12/2019 to 31/12/2024

Name of the Institute(s) or Company(ies)
Erasmus MC, Erasmus MC
s-Gravendijkwal 230
Afdeling Urologie
Rotterdam 3015 CE
The Netherlands;

3. Is the same GMO release planned elsewhere in the Community?
Germany; Spain; France; United Kingdom; Italy; Poland;

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

GMO characterization

GMO is a:
DNA Virus

Identity of the GMO:
Genus: Mastadenovirus
Species: Human adenovirus

rAd-IFN is a replication-incompetent adenovirus derived from wild-type human Ad5.
Therefore infection leading to replication of the GMO (and therefore potential for dispersal) is not possible under normal circumstances.
rAd-IFN was generated by recombination between an IFN╬▒2b-containing plasmid and a derivative of human adenovirus type 5 (Ad5), which were co-transfected into human embryonic kidney (HEK) 293 cells. During viral propagation, the proteins necessary for viral replication are supplied in trans by the HEK 293 host cells

Information relating to the recipient or parental organisms from wich the GMO is derived
Common NameGenusSpeciesSubspeciesStrainPathovar
Ad5Mastadenovirushuman adenovirusGroup III, Subgroup Cserotype 5N/A

European Commission administrative information

Consent given by the Member State Competent Authority:
06/11/2019 00:00:00