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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 GMPt 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 Name	Genus	Species	Subspecies	Strain	Pathovar
HAd5	Mastadenovirus	wildtype human adenovirus (HAd) - C	wildtype human adenovirus (HAd) serotype 5

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known