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Notification report


Full notification file


General information

Notification Number
B/SE/14/000614-64

Member State to which the notification was sent
Sweden

Date of acknowledgement from the Member State Competent Authority
28/09/2015

Title of the Project
Phase I/IIa Study of recombinant adenovirus in patients with neuroendocrine tumors; safety and efficacy.

Proposed period of release:
01/01/2016 to 30/06/2018

Name of the Institute(s) or Company(ies)
Uppsala University, Department of Immunology, Genetics and Pathology, Uppsala, Sweden.;


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:
AdVince (also known as Ad5PTD(CgA-E1AmiR122) is a neuroendocrine-specific replicating oncolytic adenovirus designed to treat patients with neuroendocrine tumors and their liver metastases. It is a human group C (serotype 5) adenovirus, that features a human chromogranin A promoter and mouse H19 insulator controlling expression of the adenoviral E1A gene for selective replication of the virus in neuroendocrine cells. It also contains microRNA target sequences inserted in the 3’UTR of E1A for reduced virus replication in normal hepatocytes. Furthermore, a peptide transduction domain (PTD) motif is inserted in the capsid (hexon protein, hypervariable region 5) for increased infectivity (Leja, Dzojic et al. 2007, Leja, Nilsson et al. 2010, Yu, Jin et al. 2011). It does not contain the E1B region.

Information relating to the recipient or parental organisms from wich the GMO is derived
Common NameGenusSpeciesSubspeciesStrainPathovar
Ad5Mastadenovirushuman adenovirussubgroup Cserotype 5-

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known