B/BE/01/B7
| Company/Institution | Transgene S.A. |
| Parental organism | Attenuated Vaccinia Virus (Ankara Strain) |
| Transgene(s) | sequences coding for the human MUC-1 antigen and IL-2 |
| Treated organism | Humans |
| Title of the project | Specific immunotherapy against MUC-1 antigen - Study TG4010.04 : "Phase II study with TG4010(MVA-MUC-1-IL-2) in patients with metastatic breast cancer", Study TG4010.05 : "Phase II study with TG 4010 in patients with non small cell lung cancer" |
| Treatment indication | metastatic breast cancer |
| Administration route(s) | subcutaneous |
| Total number of subjects foreseen | not specified (up to 166 patients in Europe) |
| Foreseen duration of release | |
| Effective year(s) of release | 2 years |
| Current status | Trials completed |
| Locations | Erasme Hospital, Brussels |
| Number of sites | 1 |
| Monitoring | |
| Type of procedure | Classical procedure - Art. 9§1 of Royal Decree of 18 December 1998 |
| Notes | |
| Other |
Information for the public
- B/BE/01/B7 - Public information sheet (written by the notifier)
- B/BE/01/B7 - Fiche d'information destinée au public (préparée par le notifiant)
- B/BE/01/B7 – Informatie fiche bestemd voor het publiek (voorbereid door de kennisgever)
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B/BE/01/B7 - Summary Notification Information Format (SNIF)
Public information presented according to the provisions of Directive 90/220/EEC
Information related to the decision procedure
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B/BE/01/B7 - Advies van de a.i. Adviesraad voor Bioveiligheid / Avis du Conseil Consultatif de Biosécurité a.i.
04 February 2002: The Biosafety Advisory Council a.i. issues a positive advice for this trial (the advice is written in French and Dutch)
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B/BE/01/B7 – Advice of the Regional Competent Authority
5 March 2002: The Regional Competent Authority issues a positive advice
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B/BE/01/B7 - Decision of the Federal Public Service (FINAL DECISION)
20 March 2002: The Federal Public Service Health, Food chain safety and Environment gives a final decision (positive with conditions) for this trial.
