B/BE/15/BVW1 - Fiche d'information destinée au public (préparée par le notifiant)12 October 2015 - The Biosafety Council issues a positive advice (with conditions) for this trial
EU record number
B/BE/15/BVW1
EudraCT number
2014-000185-22
Company / Sponsor
Amgen Ltd
Phase
I and III
Treated organism
Humans
Indication category
Cancer therapy
Disease
Melanoma
Therapeutic approach
Immunotherapy
Genetic modification
Insertion of a gene expressing granulocyte-macrophage colony-stimulating factor (GM-CSF) - Functional deletion of two genes (ICP34.5 and ICP47) of the HSV-1 genome
Method of transfer of nucleic acid of interest
Herpes simplex virus 1 (HSV-1)
Administered biological material
Recombinant HSV-1 D(ICP34,5 & ICP47)
Route of administration
intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions
Locations in Belgium
UZ Gent, Cliniques Universitaires St Luc (Brussels), UZ Brussels, CHU de Liège
Nr of subjects
660 subjects worldwide, 35 subjects foreseen in Belgium
Foreseen duration
6 years
Type of procedure
Contained use and Deliberate release
Current status
Authorized
Pharmaceutical study code
20110265