Back

Notification report


Full notification file


General information

Notification Number
B/NL/07/011

Member State to which the notification was sent
Netherlands

Date of acknowledgement from the Member State Competent Authority
13/12/2007

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)
University Medical Center Groningen, Hanzeplein 1
9713 GZ Groningen
PO Box 30.001
9700 RB Groningen
The Netherlands;


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

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

If yes, notification number(s):


GMO characterization

GMO is a:
Other: See attached SNIF document

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 NameGenusSpeciesSubspeciesStrainPathovar
-

Final report


European Commission administrative information

Consent given by the Member State Competent Authority:
Not known