Search the database for deliberate release of GM medicinal products
Displaying 1 - 9 of 9
EU record number | Title | Company / Sponsor | Treated organism | Genetic modification |
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B/BE/24/BVW4 | A phase 3 multinational, open-label, systemic gene delivery study to evaluate the safety and efficacy of SRP-9003 in subjects with limb girdle muscular dystrophy 2E/R4 | Sarepta Therapeutics | Humans | Non-replicating recombinant vector derived from adeno-associated virus AAV, serotype rh74, lacking all AAV viral genes and carrying the full-length sarcoglycan-beta (SGCB) gene |
B/BE/22/BVW6 | A phase 3, Multinational, Randomized, Double-Blind, Placebo-Controlled Systemic Gene Transfer Therapy Study to Evaluate the Safety and Efficacy of SRP-9001 in Non-Ambulatory and Ambulatory Subjects With Duchenne Muscular Dystrophy (ENVISION) | Sarepta Therapeutics | Humans | Non-replicating recombinant vector derived from adeno-associated virus AAV, serotype rh74, lacking all AAV viral genes and carrying the human micro-dystrophin (hMicro-Dys) gene |
B/BE/21/BVW5 | A Phase 3 Multinational, Randomized, Double-Blind, Placebo-Controlled Systemic Gene Delivery Study to Evaluate the Safety and Efficacy of SRP-9001 in Subjects With Duchenne Muscular Dystrophy (EMBARK) | Sarepta Therapeutics | Humans | Non-replicating recombinant vector derived from adeno-associated virus AAV, serotype rh74, lacking all AAV viral genes and carrying the human micro-dystrophin (hMicro-Dys) gene |
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/07/BVW3 | A multi-centre phase I study to evaluate the safety and tolerability of a heterologous prime-boost vaccination with INX102-3697 HBV pDNA/INX102-0557 HBV MVA in healthy volunteers and HBeAg+ chronic hepatitis patients | GENimmune N.V. | Humans | Hepatitis B virus polyepitope gene |
B/BE/04/BV1 | Evaluation of the safety of Feline Herpes Virus, bivalent deleted live vaccine, administered as intranasal vaccine to cats | Pfizer, Animal Health Group | cats | gene for the env glycoprotein or gene for the gag protein of the Feline immunodeficiency virus (FIV) |
Only notified under the "contained use" procedure. Dossier submitted on 10/06/2003. | A phase 1 randomized, placebo-controlled, double-blind, dose escalation trial to evaluate the safety and immunogenicity of tgAAC09, a gag-PR-DRT AAV HIV vaccine | International AIDS Vaccine Initiative (IAVI) | Humans | genes for the gag, protease and part of the reverse transcriptase proteins of HIV-1 |
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 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) |