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Notification report

Full notification file


General information

Notification Number
B/NL/08/002

Member State to which the notification was sent
Netherlands

Date of acknowledgement from the Member State Competent Authority
25/02/2008

Title of the Project
A Phase 3 Clinical Trial to Evaluate the Safety and Efficacy of Treatment with 2 mg
Intralesional Allovectin-7® [bicistronic plasmid DNA vector VCL-1005 encoding
Human Leukocyte Antigen (HLA)-B7 and β-2 microglobulin, formulated with the
cationic lipid delivery system DMRIE-DOPE] Compared to Dacarbazine (DTIC) or
Temozolomide (TMZ) in Subjects with Recurrent Metastatic Melanoma

Proposed period of release:
01/06/2008 to 01/06/2018

Name of the Institute(s) or Company(ies)
Leiden University Medical Center, Albinusdreef 2
2333 ZA Leiden
PO Box 9600
2300 RC Leiden
The Netherlands;


3. Is the same GMO release planned elsewhere in the Community?
Yes:


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

If yes, notification number(s):


GMO characterization

GMO is a:
Other: True

Identity of the GMO:
Not relevant. The VCL-1005 pDNA does not have a taxonomic classification.

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

Common Name	Genus	Species	Subspecies	Strain	Pathovar
pBR322

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known