Full notification fileGeneral informationNotification NumberB/NL/03/08Member State to which the notification was sentNetherlandsDate of acknowledgement from the Member State Competent Authority07/04/2004Title of the ProjectA phase 1 dose escalation trial of MDX- 010 in combination with CG1940 and CG8711 in patients with metastatic HRPCProposed period of release:01/06/2004 to 01/04/2006Name of the Institute(s) or Company(ies)VU Medical Center, Department of medical oncology
De Boelelaan 1117, 1007 MB A’dam - The Netherlands;
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:DNA VirusIdentity of the GMO:Allogeneic, irradiated prostate cancer cell lines PC3 and LnCAP transduced with
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rAAV-GM-CSF. After transduction cells were cloned and selected for positive production of GM-CSF and negative testing voor AAV or helper viruses. Subsequently, cells were expanded and prepared for vaccination. Two prostate cancer cell lines are transduced for clinical use (CG1940 and CG8711).
A GM-CSF gene is ex vivo transferred into the prostate cancer cells using a replication deficient recombinant adeno-associated viral vector (Family Parvovirideae, genus Dependovirus, Species adeno-associated virus 2).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:Yes07/04/2004 00:00:00Remarks:
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