B/BE/11/BVW2 - Public information sheet (written by the notifier)7 August 2012: The Biosafety Advisory Council issues a positive advice (with conditions) for this trial.
EU record number
B/BE/11/BVW2
EudraCT number
2010-021196-85
Company / Sponsor
BN-Immunotherapeutics
Phase
III
Treated organism
Humans
Indication category
Cancer therapy
Disease
Castrate-resistant prostate cancer
Therapeutic approach
Immunotherapy
Genetic modification
Human gene coding for the prostate-specific antigen (PSA) and genes encoding 3 human immunological costimulatory molecules
Method of transfer of nucleic acid of interest
Attenuated Vaccinia Virus (NYCBH Strain) + Attenuated Fowlpox Virus
Administered biological material
Recombinant Attenuated Vaccinia Virus + Recombinant Attenuated Fowlpox Virus
Route of administration
subcutaneous
Locations in Belgium
ZNA Middelheim, Antwerp - Cliniques St Luc, Brussels - Heilig Hart Ziekenhuis, Roeselaere - AZ Maria Middelares, Gent - UZ Gasthuisberg, Leuven - Institut Bordet, Brussels
Nr of subjects
1200 worldwide, 10 patients in Belgium
Foreseen duration
1 year
Type of procedure
Contained use and Deliberate release
Pharmaceutical study code
BNIT-PRV-301