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Notification report


Full notification file


General information

Notification Number
B/ES/15/15

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
09/12/2015

Title of the Project
A phase I, unicentric, open -label and dose escalation clinical study to evaluate the safety and the antitumoral activity of VCN-01 in patients with refractory retinoblastoma

Proposed period of release:
01/12/2015 to 31/12/2018

Name of the Institute(s) or Company(ies)
Sant Joan de Déu Research Foundation, Santa Rosa 39-57, 3ª planta
08950 Esplugues 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;

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 matri x-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:
Yes
03/04/2016 00:00:00
Remarks: