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

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

Pharmaceutical study code

TG4010.04, TG4010.05

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)

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

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)

B/BE/01/B7 – Advice of the Regional Competent Authority

5 March 2002: The Regional Competent Authority issues a positive advice

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.