Full notification fileGeneral informationNotification NumberB/NL/10/003Member State to which the notification was sentNetherlandsDate of acknowledgement from the Member State Competent Authority04/03/2010Title of the ProjectIntradermal vaccination with naked DNA encoding the fusion protein domain1 of tetanus toxin fragment C and MART-1(aa 26-35) for the induction of MART-1-specific T cell immunity in stage IV melanoma patientsProposed period of release:01/07/2010 to 01/07/2020Name of the Institute(s) or Company(ies)Leiden University Medical Center, Albinusdreef 2
2333 ZA Leiden
PO Box 9600
2300 RC Leiden
3. Is the same GMO release planned elsewhere in the Community?NoHas the same GMPt been notified elsewhere by the same notifier?NoGMO characterizationGMO is a:Other: FalseIdentity of the GMO:The medicinal product is not a GMO per se. It is an investigational gene therapy
medicinal product consisting of a purified plasmid DNA (pDNA) drug substance.
The plasmid DNA does not have a taxonomic classification.Information relating to the recipient or parental organisms from wich the GMO is derived
European Commission administrative informationConsent given by the Member State Competent Authority:Not known