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
. |
An open-label, phase I, dose-escalation and safety study of two intramuscular injections at dose of 2.9 log or 4 log CCID50 of the recombinant HIV I clade B measles vaccine vector in healthy adults. |
Institut Pasteur - Paris |
Humans |
Gag, Pol, Nef genes of HIV |
| B/BE/01/B7 |
Specific immunotherapy against MUC-1 antigen - Study TG4010.04 : "Phase II study with TG4010(MVA-MUC-1-IL-2) in patients with metastatic breast cancer", Study TG4010.05 : "Phase II study with TG 4010 in patients with non small cell lung cancer" |
Transgene S.A. |
Humans |
sequences coding for the human MUC-1 antigen and IL-2 |
| B/BE/01/V6 |
Evaluation of efficacy of Salmonella Dublin-Typhimurium vaccine, double gene deleted avirulent live culture in calves. |
Pharmacia Animal health |
calves |
genetic modification of Salmonella enterica by deletion of 2 genes (ssaC and ssaT) |
| Only notified under the "contained use" procedure. Dossier submitted on
. |
A phase III, multi-center, open-label, randomized study to compare the effectiveness and safety of intratumoral administration of INGN 201 in combination with chemotherapy versus chemotherapy alone in 288 patients with recurrent squamous cell carcinoma of |
Introgen Therapeutics, Inc. |
Humans |
Wild-type p53 |
| Only notified under the "contained use" procedure. Dossier submitted on
. |
A phase III, multi-center, open-label, randomized study to compare the overall survival and safety of bi-weekly intratumoral administration of INGN 201 versus weekly methotrewate in 240 patients with refractory squamous cell carcinoma of the head and neck |
Introgen Therapeutics, Inc. |
Humans |
Wild-type p53 |
