Search the database for deliberate release of GM medicinal products

Displaying 1 - 13 of 13
EU record number Title Company / Sponsor Treated organism Genetic modification
B/BE/20/BVW6 Dossier withdrawn by the notifier Pfizer Humans Non-replicating recombinant vector derived from adeno-associated virus AAV6 serotype, containing a codon-optimised version of the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/20/BVW3 A Phase I/IIa study of intra-tumoral BT-001 (TG6030) administered alone and in combination with pembrolizumab in patients with cutaneous or, subcutaneous lesions or easily injectable lymph nodes of metastatic/advanced solid tumors Transgene Humans Replicative oncolytic vaccinia virus derived from the Copenhagen strain, genetically modified by inactivation of its thymidine kinase (TK) and ribonucleotide reductase (RR) genes and by addition of genes encoding for the human granulocyte-macrophage colony-stimulating factor (hGM-CSF) cytokine and for a monoclonal antibody targeting the Cytotoxic T-Lymphocyte-Antigen 4 (CTLA-4).
B/BE/18/BVW1 A Phase I/IIa study of TG6002 (VV TK-RR-FCU1) administered by intravenous (IV) infusions in combination with oral flucytosine (5-FC) in patients with advanced gastro-intestinal (GI) tumors Transgene Humans Engineered replicative oncolytic vaccinia virus (VV) derived from the Copenhagen strain. It contains three genetic modifications: 1) deletion of the viral thymidine kinase (TK) gene, 2) deletion of the viral ribonucleotide reductase (RR) gene and 3) insertion of the chimeric yeast FCU1 suicide gene in the TK locus.
Only notified under the "contained use" procedure. Dossier submitted on 25/04/2018. A Phase 3, Randomized, Open-Label Study Evaluating the Efficacy of Axicabtagene Ciloleucel versus Standard of Care Therapy in Subjects with Relapsed/Refractory Diffuse Large B Cell Lymphoma (ZUMA-7) Kite Pharma Humans Chimeric antigen receptor against CD19
B/BE/17/BVW1 A phase II study evaluating the efficacy and the safety of first-line chemotherapy combined with TG4010 and nivolumab in patients with advanced non-squamous 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 22/03/2016. Phase I study to evaluate the safety and immunogenicity of a bivalent recombinant vaccine against human cytomegalovirus (HCMV). Hookipa Biotech AG Humans Two replication-deficient lymphocytic choriomeningitidis virus (rLCMV) vectors, one expressing a truncated gBprotein of HCMV and one expressing the pp65 protein of the human CMV
Only notified under the "contained use" procedure. Dossier submitted on 14/10/2015. A phase II, single-arm, multi-center trial to determine the efficacy and safety of CTL019 in pediatric patients with relapsed and refractory B-cell acute lymphoblastic leukemia Novartis Pharma Services AG Humans Chimeric antigen receptor against CD19
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/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/07/BVW1 Phase 1b and Phase 2a clinical trials with an hIL-10-expressing Lactococcus lactis ActoGeniX N.V. Humans Gene coding for the human interleukin-10 (hIL-10)
Only notified under the "contained use" procedure. Dossier submitted on 04/06/1998. 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 02/01/1996. Gene therapy for the treatment of glioblastoma multiforme with in vivo tumor transduction with the herpes simplex thymidine kinase gene /ganciclovir system Sandoz Pharma, LTD Thymidine Kinase (HSV-TK1), neomycin resistance (NeoR)