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B-GT/1: Regulatory and clinical data
(Authors: M. Sneyers and M. Goossens - Last revised:
February 28, 2006
)
|
Title |
Gene therapy for the treatment of glioblastoma multiforme with in vivo tumor transduction with the herpes simplex thymidine kinase gene /ganciclovir system |
|
Company or sponsor |
Sandoz Pharma, LTD |
|
Pharmaceutical study code |
GLIB 201-E-00 |
|
Phase |
II |
|
Unicenter/multicenter study |
multicenter |
| Clinical data | see table 2 |
|
Installation |
Hôpital Erasme, Brussels |
|
Authorisation procedure |
contained use, first use (see relevant regulation) |
|
Application number |
SBB 219 95/0562 |
|
User(s) |
Prof. Dr J. Brotchi and Prof. Dr T. Velu |
|
Receipt date |
02/01/1996 |
|
Biosafety Council meeting date |
20/03/1996 |
|
Authorisation date |
29/03/1996 |
|
Status |
trial completed |
|