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Notification report


Full notification file


General information

Notification Number
B/IT/17/01

Member State to which the notification was sent
Italy

Date of acknowledgement from the Member State Competent Authority
20/03/2017

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:
01/04/2017 to 31/12/2019

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/ES/16/04; B/FI/15/1MA;

GMO characterization

GMO is a:
DNA Virus

Identity of the GMO:
Genus Mastadenovirus
Species Adenovirus C, serotype 5


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

European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
21/07/2017 00:00:00
Remarks: