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Notification report


Full notification file


General information

Notification Number
B/ES/20/26

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
20/10/2020

Title of the Project
Phase I study of VCN-01 adenovirus for recurrent malignant brain tumors in pediatric and young adult patients

Proposed period of release:
01/04/2020 to 30/04/2027

Name of the Institute(s) or Company(ies)
Clínica Universidad de Navarra/Universidad de Navarra, Avda. Pío XII 36
31008 Pamplona
Tlfno.: 948 255 400;


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

Has the same GMO been notified elsewhere by the same notifier?
No

GMO characterization

GMO is a:
DNA Virus

Identity of the GMO:
Family: Adenoviriae
Gender: Mastadenovirus
Species: Type 5 human Adenovirus (HAd5)

The OMG (VCN-01) is an oncolytic adenovirus, replication competent and selective for tumor cells. VCN-01 selectively expresses a tumor extracellular matrix degrading enzyme (hyaluronidase) and its genome contains four additional genetic modifications with respect to the wild strain HAd5.


Information relating to the recipient or parental organisms from wich the GMO is derived
Common NameGenusSpeciesSubspeciesStrainPathovar
HAd5MastadenovirusHAd5Type C adenovirus--

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known