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Notification report


Full notification file


General information

Notification Number
B/ES/09/64

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
31/08/2009

Title of the Project
Phase I clinical trial of intravenous administration of a conditionally
replicating adenovirus ICOVIR-5 in patients with locally advanced or metastasic malignant
melanoma.


Proposed period of release:
01/09/2010 to 01/12/2011

Name of the Institute(s) or Company(ies)
Institut Català d’Oncologia - IDIBELL, ;


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

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

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.

Information relating to the recipient or parental organisms from wich the GMO is derived
Common NameGenusSpeciesSubspeciesStrainPathovar
HAd5Mastadenoviruswildtype human adenovirus (HAd) - Cwildtype human adenovirus (HAd) serotype 5

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known