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Notification report

Full notification file


General information

Notification Number
B/NL/06/010

Member State to which the notification was sent
Netherlands

Date of acknowledgement from the Member State Competent Authority
25/08/2006

Title of the Project
Study G-0029 A Phase III Randomized, Open-Label Study of CG1940 and CG8711 Versus Docetaxel and Prednisone in Patients with Metastatic Hormone-Refractory Prostate Cancer who are Chemotherapy-Naive (G-0029)

Proposed period of release:
30/09/2006 to 31/12/2009

Name of the Institute(s) or Company(ies)
Raboud University Medical Center, PO Box 9101 Nijmegen 6500HB
The Netherlands;


3. Is the same GMO release planned elsewhere in the Community?
Yes:


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

GMO characterization

GMO is a:
Other: False

Identity of the GMO:
NOTE: Some countries and regulatory agencies do not consider this product to be defined as a GMO according to the definition in Article 2 of Directive 2001/18/EC. (UK, BE, SE, PL)
Allogeneic, irradiated prostate cancer cell lines PC3 and LNCaP transduced with replication defective rAAV- GM- CSF. After transduction cells were cloned and selected for production of GM-CSF and negative testing for AAV and helper viruses. Subsequently, cells were banked, and clinical lots were generated for clinical use..
The human 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
N/A	Homo	Sapiens	N/A	N/A	Caucasian, site prostate

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known