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Notification report

Full notification file


General information

Notification Number
B/NL/03/08

Member State to which the notification was sent
Netherlands

Date of acknowledgement from the Member State Competent Authority
07/04/2004

Title of the Project
A phase 1 dose escalation trial of MDX- 010 in combination with CG1940 and CG8711 in patients with metastatic HRPC

Proposed period of release:
01/06/2004 to 01/04/2006

Name 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?
No

Has the same GMPt been notified elsewhere by the same notifier?
No

GMO characterization

GMO is a:
DNA Virus

Identity 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

Common Name	Genus	Species	Subspecies	Strain	Pathovar
-	Homo	Sapiens			Caucasian, site prostate

European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
07/04/2004 00:00:00
Remarks: