Full notification fileGeneral informationNotification NumberB/NL/06/003Member State to which the notification was sentNetherlandsDate of acknowledgement from the Member State Competent Authority15/03/2006Title of the ProjectStudy 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 31/12/2009Name of the Institute(s) or Company(ies)University Hospital Maastricht, P. Debjelaan 25
Maastricht 6229 HX
3. Is the same GMO release planned elsewhere in the Community?Yes: Belgium; Germany; France; United Kingdom; Italy; Sweden; Poland; Has the same GMO been notified elsewhere by the same notifier?NoGMO characterizationGMO is a:Other: 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
European Commission administrative informationConsent given by the Member State Competent Authority:Not known
|N/A||Homo||Sapiens||N/A||N/A||Caucasian, site prostate|