Study title:
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"
EU record number:
B/BE/01/B7
Pharmaceutical study code:
TG4010.04, TG4010.05
Company / Sponsor:
Transgene S.A.
Treated organism:
Humans
Indication category:
Cancer therapy
Disease:
Metastatic Breast Cancer, Non-Small Cell Lung cancer
Therapeutic approach:
Immunotherapy
Genetic modification:
sequences coding for the human MUC-1 antigen and IL-2
Method of transfer of nucleic acid of interest:
Attenuated Vaccinia Virus (Ankara Strain)
Administered biological material:
Recombinant Attenuated Vaccinia Virus
Route of administration:
subcutaneous
Locations in Belgium:
Erasme Hospital, Brussels
Nr of subjects:
not specified (up to 166 patients in Europe)
Type of procedure:
Contained use and Deliberate release
Current status:
Authorized
Information for the public
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Public information presented according to the provisions of Directive 90/220/EEC
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Information related to the decision procedure
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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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5 March 2002: The Regional Competent Authority issues a positive advice
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20 March 2002: The Federal Public Service Health, Food chain safety and Environment gives a final decision (positive with conditions) for this trial.