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B-GT/6: Regulatory and clinical data
(Authors: M. Sneyers and M. Goossens - Last revised: February 28, 2006 )

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Title

Phase II randomized study of immunotherapy of advanced breast cancer by repeated intramuscular injection of a recombinant vaccinia virus containing sequences coding for human MUC-1 and interleukin-2 (TG1031) comparing two doses levels

Company or sponsor

Transgène

Pharmaceutical study code

TG1031.02

Phase

II

Unicenter/multicenter study

multicenter

Clinical data see table 2

Installation

Universitair Ziekenhuis Gent

Authorisation procedure

contained use, first use (see relevant regulation)

Application number

SBB 219 98/0433

User(s)

Prof. Dr S. Van Belle

Receipt date

04/06/1998

Biosafety Council meeting date

10/07/1998

Authorisation date

06/08/1998

Status

trial completed

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