Search the database for deliberate release of GM medicinal products
EU record number
Title
Company / Sponsor
Treated organism
Genetic modification
B/BE/14/BVW1
A phase 2 clinical trial with Talimogene Laherparepvec
Amgen Ltd
Humans
Insertion of a gene expressing granulocyte-macrophage colony-stimulating factor (GM-CSF) - Functional deletion of two genes (ICP34.5 and ICP47) of the HSV-1 genome
Only notified under the "contained use" procedure. Dossier submitted on 7 April 2014
.
A single-center, open-label Phase 1 study to assess safety and medical endoscopic sampling methodology and to characterize the pharmacokinetics of oral doses of AG014 in Healthy Subjects
ActoGenix
Humans
gene expressing certolizumab
B/BE/98/B6
Clinical research program : Gene-therapy by the Use of a Recombinant Adenovirus in the Treatment of p53 Deficient Cancers
Schering Plough NV/SA
Humans
wild-type p53 tumor suppressor gene
Only notified under the "contained use" procedure. Dossier submitted on 9 June 1998
.
A phase II, multi-center, open label, randomized study to evaluate biodistribution and transmission, effectiveness and safety of two treatment regimens of Ad5CMV-p53 administered by intra-tumoral injections in 40 evaluable patients with advanced squamous
Rhone-Poulenc Rorer
Humans
Wild-type p53
Only notified under the "contained use" procedure. Dossier submitted on 4 June 1998
.
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
Transgene
Humans
Muc-1 and Interleukine 2 (IL-2)
Only notified under the "contained use" procedure. Dossier submitted on 26 March 1998
.
Pilot study of immunization with recombinant canarypox virus vCP1469A expressing the MAGE-1.A1 and MAGE-3.A1 cytolytic T lymphocytes epitopes in patients with malignant melanoma, non-small cell lung carcinoma, head-and-neck squamous cell carcinoma, esopha
Pasteur Mérieux Connaught
Humans
HLA-A1 restricted CTL epitope of MAGE-1 and
MAGE-3 genes
Only notified under the "contained use" procedure. Dossier submitted on 24 October 1996
.
Prospective, open-label, parallel-group, randomized, multicenter trial comparing the efficacy of surgery, radiation, and injection of murine cells producing herpes simplex thymidine kinase vector followed by intravenous ganciclovir against the efficacy of
Genetic therapy, Inc., Sandoz Pharma, Ltd
Humans
Thymidine Kinase (HSV-TK1), neomycin resistance (NeoR)
Only notified under the "contained use" procedure. Dossier submitted on 21 October 1996
.
A phase I study in patients with recurrent or metastatic squamous cell carcinoma of the head and neck using SCH 58500 (rAd/p53) administered by single intratumoral injection
Schering Plough NV/SA
Humans
Wild-type p53
Only notified under the "contained use" procedure. Dossier submitted on 2 January 1996
.
Gene therapy for the treatment of glioblastoma multiforme with in vivo tumor transduction with the herpes simplex thymidine kinase gene /ganciclovir system
Sandoz Pharma, LTD
Thymidine Kinase (HSV-TK1), neomycin resistance (NeoR)