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/08/BVW1
MI-CP178: Study of a Live, Attenuated Intranasal Vaccine Against Respiratory Syncytial Virus (RSV) and Parainfluenza Virus Type 3 (PIV3), in Healthy 6 to < 24 Month-Old Children and in 2 Month-Old Infants MedImmune LLC
Humans
Genes of the human Parainfluenza virus fusion (F) and hemagglutinin-neuraminidase (HN) proteins; gene of the human Respiratory syncitial virus fusion protein (RSV F).
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 9 November, 2001
.
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 9 November, 2001
.
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
