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Notification report

Full notification file


General information

Notification Number
B/SE/10/EU-2010-023103-94

Member State to which the notification was sent
Sweden

Date of acknowledgement from the Member State Competent Authority
21/03/2011

Title of the Project
Phase I/IIa AdCD40L immunogene therapy for malignant melanoma in patients with disseminated disease

Proposed period of release:
01/05/2011 to 31/05/2013

Name of the Institute(s) or Company(ies)
Uppsala University, Department of Immunology, Genetics and Pathology, Uppsala, Sweden.;


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

Has the same GMPt been notified elsewhere by the same notifier?
Yes

If yes, notification number(s):
B/SE/06/EU-2006-000985-34;

GMO characterization

GMO is a:
DNA Virus

Identity of the GMO:
AdCD40L is consisting of a recombinant adenovirus group C serotype 5 E1E3 deleted vector expressing the human CD40L (CD154) gene under controll of a promoter derived from Rous Sarcoma Virus (RSV) (Leimig et al Human Gene Ther 7:1233-1239, 1996; Takahashi et al Hum Gene Ther 12:659-670, 2001).

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

Common Name	Genus	Species	Subspecies	Strain	Pathovar
Adenovirus human serotype 5 (Ad5)	Mastadenovirus	human adenovirus	subgroup C	serotype 5

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known