Summary Notification

Full notification file

General information

Notification Number
B/ES/12/17

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
23/12/2012

Title of the Project
“Phase I open Phase I trials to assess efficacy and safety of treatment with autologous mesenchymal cells infected with an oncolitic adenovirus (CELYVIR) in the treatment of paediatric patients with refractory or relapsed solid tumors”

Proposed period of release:
01/12/2011 to 31/12/2012

Name of the Institute(s) or Company(ies)
FUNDACION PARA LA INVESTIGACION
BIOMEDICA HOSPITAL UNIVERSITARIO INFANTIL NIÑO JESUS, ;

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

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

GMO characterization

GMO is a:
DNA Virus

Identity of the GMO:
ICOVIR-5 is an oncolytic adenovirus which in this study will infect mesenchymal cells
(CELYVIR) for their later ninfusión to patients with solid refractory or relapsed solid
tumours. This is why the name of the study is CELYVIR (mesenchymal cells infected with
adenovirus ICOVIR). ICOVIR-5 (HAd5-DM-E2F-K-Δ24-RGD) is an oncolytic adenovirus
derived from HAd5. It has been designed for systemic treatment of disseminated tumors. ICOVIR-5
genome contains several modifications that confer selective replication in tumoral cells with
deregulated retinoblastoma/E2F pathway. ICOVIR-5 includes the following modifications:
1. Endogenous E1A promoter substitution by E2F-1 promoter, to control viral E1A protein
expression.
2. DM-1 genomic insulator insertion preceding E2F-1 promoter.
3. Kozak sequence insertion at E1A start codon (K)
4. 8-amino acid deletion at the pRb-binding domain in E1A protein (Δ24 deletion)
5. RGD-tripeptide insertion in the viral fiber protein.

Information relating to the recipient or parental organisms from wich the GMO is derived

Common Name	Genus	Species	Subspecies	Strain	Pathovar
HAd5	Mastadenovirus	wiildtype human adenovirus (Had) - C	wiildtype human adenovirus (Had) serotype 5	-	-

European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
18/06/2012 00:00:00
Remarks:

Notification report