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)
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?

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

If yes, notification number(s):

GMO characterization

GMO is a:
Other: See SNIF file

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

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known