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Notification report


Full notification file


General information

Notification Number
B/ES/20/09

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
07/03/2020

Title of the Project
Clinical trial of the feasibility of combining AloCelyvir with chemotherapy and radiotherapy for the treatment of children and adolescents with relapsed or refractory solid cranial tumors

Proposed period of release:
01/04/2020 to 31/12/2022

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 GMO been notified elsewhere by the same notifier?
Yes

If yes, notification number(s):
B/ES/11/27; B/ES/12/17;

GMO characterization

GMO is a:
DNA Virus

Identity of the GMO:
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 NameGenusSpeciesSubspeciesStrainPathovar
HAd5MastadenovirusHAd5---

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known