Notification report

Full notification file

General information

Notification Number

Member State to which the notification was sent

Date of acknowledgement from the Member State Competent Authority

Title of the Project
Study G-0034
A Phase III 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

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

Name of the Institute(s) or Company(ies)
AMC Amsterdam, Meibergdreef 9
1105 AZ Amsterdam
The Netherlands;

3. Is the same GMO release planned elsewhere in the Community?
Belgium; Germany; France; United Kingdom; Italy; Sweden; Poland;

Has the same GMO been notified elsewhere by the same notifier?

GMO characterization

GMO is a:

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 NameGenusSpeciesSubspeciesStrainPathovar
N/AHomoSapiensN/AN/ACaucasian, site prostate

Final report

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known