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Notification report


Full notification file


General information

Notification Number
B/ES/18/14

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
04/07/2018

Title of the Project
A Phase I Study to Evaluate the Safety, Tolerability, and Efficacy of VCN-01 in Combination With Durvalumab (MEDI4736) in Subjects With Recurrent/ Metastatic Squamous Cell Carcinoma of the Head and Neck

Proposed period of release:
01/09/2018 to 31/12/2020

Name of the Institute(s) or Company(ies)
Institut Català d’Oncologia (ICO), Gran Via 199-203
08908 Hospitalet de Llobregat, Barcelona;


3. Is the same GMO release planned elsewhere in the Community?
No

Has the same GMO been notified elsewhere by the same notifier?
Yes

If yes, notification number(s):
B/ES/13/04; B/ES/13/05; B/ES/15/15;

GMO characterization

GMO is a:
DNA Virus

Identity of the GMO:
Order: Adenoviriae
Genus: Mastadenovirus
Species: Adenovirus humano tipo 5 (HAd5)

The GMO (VCN-01) is an oncolytic adenovirus, which is a replication competent virus selective of tumoral cells. VCN-01 selectively expresses a matrix-degrading enzyme (hyaluronidase) and its genome contains 4 genetic modifications with respect to the wild-type virus (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