Search the database for deliberate release of GM medicinal products

Displaying 1 - 6 of 6
EU record number Title Company / Sponsor Treated organism Genetic modification
B/BE/18/BVW7 Phase III trial investigating a AAV vector containing a variant of human factor IX gene administered to adult subjects with severe or moderately-severe hemophilia B uniQure biopharma B.V. Humans Recombinant adeno associated viral vector containing the wild type modified to express the Padua derivative of human coagulation factor IX cDNA
Only notified under the "contained use" procedure. Dossier submitted on 24/04/2018. A Phase 2a Randomized, Double-blind, Placebo-controlled rial to Assess the safety, Immunogenicity, and Efficacy of the Recombinant MVA-BN-RSV Vaccine against Respiratory Syncytial Virus Infection in the Virus Challenge Model in Healthy Adult Volunteers Bavarian Nordic A/S Humans Vaccinia virus Ankara strain expression glycoproteins of different RSV strain (MVA-BN)
Only notified under the "contained use" procedure. Dossier submitted on 21/02/2018. Efficacy and safety of bilateral intravitreal injection of GS010: a randomized, double-masked, placebo-controlled trial in subjects affected with G11778A ND4 leber hereditary optic neuropathy for up to one year. GenSight Biologics Humans human wild-type MT-NDA (mitochondrial NADH Dehydrogenase 4)
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/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 24/10/1996. Prospective, open-label, parallel-group, randomized, multicenter trial comparing the efficacy of surgery, radiation, and injection of murine cells producing herpes simplex thymidine kinase vector followed by intravenous ganciclovir against the efficacy of Genetic therapy, Inc., Sandoz Pharma, Ltd Humans Thymidine Kinase (HSV-TK1), neomycin resistance (NeoR)