Back

Notification report


Full notification file


General information

Notification Number
B/CZ/16/2

Member State to which the notification was sent
Czech Republic

Date of acknowledgement from the Member State Competent Authority
17/05/2016

Title of the Project
A phase I, single-arm clinical trial to evaluate the safety and immune activation of the combination of DCVAC/PCa, an active cellular immunotherapy, and ONCOS-102, an immune-priming adenovirus, in men with advanced metastatic castration-resistant prostate cancer

Proposed period of release:
01/07/2016 to 30/09/2018

Name of the Institute(s) or Company(ies)
Nemocnice na Homolce, Roentgenova 2/37
Praha 5-15030
Czech Republic;


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:
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 CSerotype 5--

European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
06/09/2016 00:00:00
Remarks:
The location of the trial is the hospital Nemocnice na Homolce, Prague, Czech Republic.