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Notification report


Full notification file


General information

Notification Number
B/ES/16/04

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
03/02/2016

Title of the Project
A randomised Phase II open-label study with a Phase Ib safety lead-in cohort of ONCOS 102, an immune-priming GM-CSF coding oncolytic adenovirus, and pemetrexed/cisplatin in patients with unresectable malignant pleural mesothelioma

Proposed period of release:
01/04/2016 to 31/12/2018

Name of the Institute(s) or Company(ies)
Targovax Oy, ;


3. Is the same GMO release planned elsewhere in the Community?
Yes:
United Kingdom;

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

If yes, notification number(s):
B/FI/15/1MA;

GMO characterization

GMO is a:
DNA Virus

Identity of the GMO:
Identity of the GMO (genus and species)
Genus Mastadenovirus
Species Adenovirus C, serotype 5
ONCOS-102 (previously known as CGTG-102) is a genetically modified replication competent oncolytic human adenovirus based on serotype 5. It is armed with GMCSF transgene and has a 24 bp deletion restraining the replication exclusively in tumors. The viral capsid has been modified for effective transduction of tumor cells.


Information relating to the recipient or parental organisms from wich the GMO is derived
Common NameGenusSpeciesSubspeciesStrainPathovar
-MastadenovirusAdenovirus 5Serotype 5--

European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
21/04/2016 00:00:00
Remarks: