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B-GT/12: Regulatory and clinical data
(Authors: M. Sneyers and M. Goossens - Last revised:
February 28, 2006
)
Title |
Randomized, multicenter, phase II study evaluating the clinical efficacy of TG4010(MVA-MUC-1-IL-2) in association with chemotherapy in patients with non small cell lung cancer |
Company or sponsor |
Transgene S.A. |
Pharmaceutical study code |
TG4010.05 |
Phase |
II |
Unicenter/multicenter study |
multicenter but only one center in Belgium |
| Clinical data | see table 2 |
Installation |
Hôpital Erasme, Bussels |
Authorisation procedure 1 |
contained use, new operation (see relevant regulation) |
Application number |
SBB 219 2001/1139 |
User(s) |
Prof. T. Velu |
Receipt date |
19/11/2001 |
Biosafety Council meeting date |
04/02/2002 |
Authorisation date |
25/06/2002 |
Authorisation procedure 2 |
deliberate release for research and development purposes (see regulation in french - in dutch) |
Application number |
|
Status |
trial completed |
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