B/BE/98/B6 - Advice of the Division of Biosafety and Biotechnology (SBB)2 June 1999 - The SBB issues a positive advice (with conditions) for this trial.
EU record number
B/BE/98/B6
Company / Sponsor
Schering Plough NV/SA
Treated organism
Humans
Indication category
Cancer therapy
Disease
Ovarian and primary peritoneal cancer
Therapeutic approach
Tumor suppressor gene
Genetic modification
wild-type p53 tumor suppressor gene
Method of transfer of nucleic acid of interest
Human Adenovirus serotype 5
Administered biological material
Recombinant Adenovirus D (E3, E1A, E1B, pIX)
Route of administration
Intraperitoneal
Locations in Belgium
Cliniques Universitaires Saint-Luc, Brussels - Akademisch Ziekenhuis, Vrije Universiteit Brussel - Hôpital Erasme, Brussels - Akademisch Ziekenhuis St Augustinus, Wilrijk
Nr of subjects
not specified (up to 360 worldwide)
Type of procedure
Contained use and Deliberate release
Current status
Authorized
Pharmaceutical study code
I98-102