Search the database for deliberate release of GM medicinal products
| EU record number |
Title |
Company / Sponsor |
Treated organism |
Genetic modification |
| B/BE/11/V3 |
Evaluation of the safety and efficacy of the vaccine PB-116 in the control of porcine pleuropneumonia caused by Actinobacillus pleuropneumoniae |
Laboratorios Hipra S.A. |
pigs |
no new genes but deletion of a segment of gene A from which depends the haemolytic activity of the pathogen |
| B/BE/11/BVW2 |
Clinical Study BNIT-PRV-301 - A Randomized, Double-blind, Phase 3 Efficacy Trial of PROSTVAC +/- GM-CSF in Men With Asymptomatic or Minimally Symptomatic Metastatic, Castrate-Resistant Prostate Cancer |
BN-Immunotherapeutics |
Humans |
Human gene coding for the prostate-specific antigen (PSA) and genes encoding 3 human immunological costimulatory molecules |
| B/BE/11/BVW1 |
A Phase IIb/III randomized, double-blind, placebo-controlled study comparing first-line therapy with or without TG4010 immunotherapy product in patients with stage IV non-small cell lung cancer (NSCLC) |
Transgene |
Humans |
sequences coding for human mucine 1 (MUC1) antigen and interleukin-2 (IL2) |
| B/BE/09/BVW1 |
A randomized, double blind, placebo controlled, parallel group, multicenter study of the safety and response rate of 3 subcutaneously administered doses of 5 x 10^7 pfu RO5217790 in patients with high grade cervical intraepithelial neoplasia grade 2 |
N.V. Roche S.A. |
Humans |
E6 and E7 genes of the HPV16 virus and gene of the human Interleukin-2 (hIL2) |
| 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
. |
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
. |
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
. |
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 |
