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B-GT/1: Regulatory and clinical data
(Authors: M. Sneyers and M. Goossens - Last revised: February 28, 2006 )

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Title

Gene therapy for the treatment of glioblastoma multiforme with in vivo tumor transduction with the herpes simplex thymidine kinase gene /ganciclovir system

Company or sponsor

Sandoz Pharma, LTD

Pharmaceutical study code

GLIB 201-E-00

Phase

II

Unicenter/multicenter study

multicenter

Clinical data see table 2

Installation

Hôpital Erasme, Brussels

Authorisation procedure

contained use, first use (see relevant regulation)

Application number

SBB 219 95/0562

User(s)

Prof. Dr J. Brotchi and Prof. Dr T. Velu

Receipt date

02/01/1996

Biosafety Council meeting date

20/03/1996

Authorisation date

29/03/1996

Status

trial completed

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