1. catapult cell therapy
  2. uniqure biopharma b.v
  3. uz antwerpen
  4. actogenix
  5. vion pharmaceuticals, inc.
  6. pharmacia animal health
  7. pasteur merieux connaught
  8. merial
  9. pfizer
  10. Search the database for deliberate release of GM medicinal products

Search the database for deliberate release of GM medicinal products

Displaying 1 - 15 of 15
EU record number Title Company / Sponsor Treated organism Genetic modification
B/BE/24/BVW5 Phase 3, open-label, single-arm study to evaluate efficacy and safety of FIX gene transfer with PF-06838435 (rAAV-Spark100-hFIX-R338L) in adult male participants with moderately severe to severe hemophilia B (FIX:C ≤2%) (BeneGene-2) Pfizer Humans Recombinant adeno associated viral vector containing the codon-optimised human factor IX (FIX) minigene (R338L variant)
B/BE/21/BVW9 Dossier withdrawn by the notifier ActoGenix Humans V181 is a live attenuated dengue quadrivalent vaccine rDENVΔ30 where the four viral components of V181 (one for each serotype) present a deletion of 30 nucleotides in the 3’ non‐coding region (Δ30)
B/BE/20/BVW6 Dossier withdrawn by the notifier Pfizer Humans Non-replicating recombinant vector derived from adeno-associated virus AAV6 serotype, containing a codon-optimised version of the human Factor VIII gene
B/BE/20/BVW4 A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of PF-06939926 for the Treatment of Duchenne Muscular Dystrophy Pfizer Humans Non-replicating recombinant vector derived from adeno-associated virus AAV9, lacking all AAV viral genes and containing a miniaturized version of the human dystrophin gene
B/BE/18/BVW5 A Phase 1b/2a study to assess the safety and tolerability of GM Lactococcus lactis in subjects with Type 1 Diabetes Mellitus Intrexon T1D Partners, LLC Humans Biologically contained strain of Lactococcus lactis, genetically modified to secrete human interleukin-10 and proinsulin
Only notified under the "contained use" procedure. Dossier submitted on 07/04/2017. Phase 1 clinical trial evaluation of two genetically modified vaccines against poliovirus UZ Antwerpen Humans Genetic modifications of the nOPV2 vaccine candidates aimed at stabilizing the genetic sequence against reversion compared to the Sabin-2 strain, nOPV2 candidate 1 (S2/cre5/S15domV/rec1/hifi3), nOPV2 candidate 2 (S2/S15domV/CpG40)
Only notified under the "contained use" procedure. Dossier submitted on 20/08/2015. A single arm Phase I/II study of the safety and efficacy of gene-modified WT1 TCR therapy in patients with myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) Catapult Cell Therapy Humans Expression of the Wilms' tumour antigen 1 (WT1)- specific T cell receptor (TCR)
Only notified under the "contained use" procedure. Dossier submitted on 07/04/2014. 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
Only notified under the "contained use" procedure. Dossier submitted on 08/05/2012. A single-center, open-label Phase 1 study to assess the effect of food/beverage and to characterisze the pharmacokinetics of single and multiple oral doses of AG013 in Healthy Subjects ActoGenix Humans Human Trefoil Factor 1
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)
B/BE/00/V15 Development of a combined vaccine against equine influenza and tetanus. Experiment outside containment (clinical trial) for the study of the safety and efficacy of an intramuscular administration of recombinant canarypoxvirus expressing equine influenza v Merial Horses haemagglutinin gene from equine influenza virus A2/Kentucky/94 or equine influenza virus A2/Newmarket/2/93
B/BE/99/VW8 Development of a combined live vaccine against feline leukemia. Experiment outside containment (clinical trial) for the study of the safety of a sucutaneous 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 25/06/1999. A phase I feasibility trial of a live, genetically modified Salmonella typhimurium bacillus (VNP20009) for the treatment of cancer by intra-tumoral injection Vion Pharmaceuticals, Inc. Humans Not relevant
Only notified under the "contained use" procedure. Dossier submitted on 26/03/1998. 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
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)