Full notification fileGeneral informationNotification NumberB/CZ/16/2Member State to which the notification was sentCzech RepublicDate of acknowledgement from the Member State Competent Authority17/05/2016Title of the ProjectA 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 cancerProposed period of release:01/07/2016 to 30/09/2018Name of the Institute(s) or Company(ies)Nemocnice na Homolce, Roentgenova 2/37
3. Is the same GMO release planned elsewhere in the Community?NoHas the same GMO been notified elsewhere by the same notifier?NoGMO characterizationGMO is a:DNA VirusIdentity 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
European Commission administrative informationConsent given by the Member State Competent Authority:Yes06/09/2016 00:00:00Remarks:The location of the trial is the hospital Nemocnice na Homolce, Prague, Czech Republic.
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