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/03/B3
Phase I multicentre study of TG1024 (Adenovirus interleukin 2) in patients with metastatic melanoma or other advanced solid tumor cancers Transgene S.A.
Humans
gene coding for human interleukin 2
Only notified under the "contained use" procedure. Dossier submitted on 10 June 2003
.
A phase 1 randomized, placebo-controlled, double-blind, dose escalation trial to evaluate the safety and immunogenicity of tgAAC09, a gag-PR-DRT AAV HIV vaccine International AIDS Vaccine Initiative (IAVI)
Humans
genes for the gag, protease and part of the reverse transcriptase proteins of HIV-1
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
