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) |
| Only notified under the "contained use" procedure. Dossier submitted on
. |
A multicenter, randomized, double-blind, placebo-controlled study evaluating the efficacy of Biobypass (ADGVVEGF121.10NH) delivered by NOGATM-guided/MYOSTARTM catheter in "no option" patients with class II-IV stable angina |
GenVec, Inc. |
Humans |
human VEGF121 |
| Only notified under the "contained use" procedure. Dossier submitted on
. |
A Controlled, Randomised, Parallel Group, Multicentre Study of the Efficacy and Safety of Herpes Simplex Virus-Thymidine Kinase Gene Therapy (CereproTM), with Subsequent Ganciclovir, for the Treatment of Patients with Operable High-Grade Glioma |
Ark Therapeutics Ltd |
Humans |
Thymidine Kinase (HSV-TK1) |
| B/BE/97/VW9 |
Development of a live vaccine against feline leukemia. Experiment outside containment (clinical trial) for the study of the safety of a subcutaneous administration of a recombinant canarypoxvirus expressing FELV genes. |
Merial |
cats |
env and gag genes of the type A virus of feline leukemia (FELV) |
| Only notified under the "contained use" procedure. Dossier submitted on
. |
A phase II gene therapy study in patients with non-small cell lung cancer using SCH58500 (rAd/p53) in combination with chemotherapy for multiple cycles |
Schering Plough NV/SA |
Humans |
Wild-type p53 |
