Search the database for deliberate release of GM medicinal products

Displaying 1 - 10 of 10
EU record number Title Company / Sponsor Treated organism Genetic modification
B/BE/21/BVW3 Phase I/II study to evaluate the safety and effects on Progranulin levels of PR006 in patients with Fronto-Temporal Dementia with Progranulin mutations (FTD-GRN). Prevail Therapeutics Humans The study involves a replication-incompetent adeno-associated virus, AAV9, lacking all AAV viral genes and encoding for the human Progranulin (GRN) gene
Only notified under the "contained use" procedure. Dossier submitted on 02/12/2019. A multicentre, open-label, single ascending dose, dose-ranging, phase I/Iia study to evaluate the safety and tolerability of an autologous antigen-specific chimeric antigen receptor T regulatory cell therapy (TX200-TR101) in living donor renal transplant Sangamo therapeutics Humans chimeric antigen receptor specific to the donor HLA A*2
B/BE/18/BVW6 Global study of a recombinant adeno-associated virus designed to address the monogenic root cause of Spinal Muscular Atrophy AveXis Humans Recombinant adeno-associated virus serotype 9 (AAV9) containing the cDNA of the human SMN (Survival Motor Neuron) gene
B/BE/18/BVW3 A phase 2 study to assess the safety and efficacy of GM Lactococcus lactis for the attenuation of oral mucositis in subjects with cancers of the head and neck Oragenics, Inc. Humans Biologically contained strain of Lactococcus lactis, genetically modified to secrete human Trefoil Factor 1 (hTFF1).
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 13/10/2000. A phase III open-label, comparative, multicentre trials to test the concept of durable virologic suppression in subjects with primary HIV-1 infection after intensive induction of quadruple HAART followed by double-blind randomization to HIV vaccination wi Glaxo Wellcome Humans vCP-1452
B/BE/98/B6 Clinical research program : Gene-therapy by the Use of a Recombinant Adenovirus in the Treatment of p53 Deficient Cancers Schering Plough NV/SA Humans wild-type p53 tumor suppressor gene
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
Only notified under the "contained use" procedure. Dossier submitted on 18/08/1997. A phase II gene therapy study in patients with non-small cell lung cancer using SCH58500 (rAd/p53) in combination with chemotherapy for multiple cycles Schering Plough NV/SA Humans Wild-type p53
Only notified under the "contained use" procedure. Dossier submitted on 21/10/1996. A phase I study in patients with recurrent or metastatic squamous cell carcinoma of the head and neck using SCH 58500 (rAd/p53) administered by single intratumoral injection Schering Plough NV/SA Humans Wild-type p53