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B-GT/15: Regulatory and clinical data
(Authors: M. Sneyers and M. Goossens - Last revised:
January 13, 2009
)
Title |
Phase II study evaluating the clinical efficacy of TG4010 (MVA-MUC1-IL2) in patients with metastatic Renal Cell Carcinoma (RCC) |
|
Company or sponsor |
Transgene S.A. |
|
Pharmaceutical study code |
TG4010.06 |
|
Phase |
II |
|
Unicenter/multicenter study |
multicenter |
|
| Clinical data | see table 2 | |
Installation |
Cliniques Universitaires Saint-Luc, Brussels |
Hôpital Erasme, Bussels |
Authorisation procedure |
contained use, subsequent use (see relevant regulation) |
contained use, new operation (see relevant regulation) |
Application number |
SBB 219 2002/1310 |
SBB 219 2001/1139* |
User(s) |
Dr J.-P. Machiels |
Prof. T. Velu |
Receipt date |
07/10/2002 |
information of SBB on 10/10/2002 |
Biosafety Council meeting date |
09/08/2002 |
09/08/2002 |
Authorisation date |
not applicable |
not applicable |
Authorisation procedure 2 |
deliberate release for research and development purposes (see regulation in french - in dutch) |
|
Application number |
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Status |
trial completed |
trial completed |
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