Notification report

Full notification file

General information

Notification Number

Member State to which the notification was sent

Date of acknowledgement from the Member State Competent Authority

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?

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

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