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Notification report

Full notification file


General information

Notification Number
B/ES/13/04

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
04/10/2012

Title of the Project
A phase I, multicenter, open‐label, dose escalation study of intravenous administration of VCN‐01 oncolytic adenovirus alone and in combination with intravenous gemcitabine in patients with
advanced solid tumors

Proposed period of release:
01/10/2012 to 31/12/2014

Name of the Institute(s) or Company(ies)
VCN Biosciences S.L., BioIncubadora I. Biopol’H
BioPol'H
Av Gran Via de l'Hospitalet 199‐203
08908 ‐ L'Hospitalet de Llobregat (Barcelona, SPAIN);


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/13/05;

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 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 Name	Genus	Species	Subspecies	Strain	Pathovar
HAd5	Mastadenovirus	HAd5	Type‐C adenovirus

European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
08/02/2013 00:00:00
Remarks: