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Notification report


Full notification file


General information

Notification Number
B/ES/18/28

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
29/10/2018

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:
01/10/2018 to 31/10/2023

Name of the Institute(s) or Company(ies)
Trizell, Ltd., Sanderum House, Oakley Road
Chinnor, Oxon OX39 4TW
United Kingdom;


3. Is the same GMO release planned elsewhere in the Community?
Yes:
Germany; Finland; United Kingdom; Italy; Netherlands; Poland;

Has the same GMO been notified elsewhere by the same notifier?
No

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 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 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
Human adenovirus type 5Mastadenovirushuman adenovirusGroup III, Subgroup Cserotype 5N/A

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known