Back

Notification report


Full notification file


General information

Notification Number
B/NL/06/001

Member State to which the notification was sent
Netherlands

Date of acknowledgement from the Member State Competent Authority
15/03/2006

Title of the Project
A Phase III1 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)
---
A Phase III1 Randomized, Open-Label Study of Docetaxel in combination with CG1940/CG8711 Versus Docetaxel and Prednisone in Taxane-Naïve Patients with Metastatic Hormone-Refractory Prostate Cancer with Pain (G 0034)


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

Name of the Institute(s) or Company(ies)
Study G-0029
University Medical Center Groningen, Hanzeplein 1
9713 GZ Groningen
The Netherlands
Study Sponsor: Cell Genesys, Inc, S. San Francisco, CA USA;
Study G-0034
VU Medical Center, Department of medical oncology
De Boelelaan 1117, 1007 MB Amsterdam
The Netherlands
Study Sponsor: Cell Genesys, Inc, S. San Francisco, CA USA;


3. Is the same GMO release planned elsewhere in the Community?
Not known

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

GMO characterization

GMO is a:
DNA Virus

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)

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 NameGenusSpeciesSubspeciesStrainPathovar
N/AHomoSapiensN/AN/ACaucasian, site prostate

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known