Search the database for deliberate release of GM medicinal products

Displaying 1 - 8 of 8
EU record number Title Company / Sponsor Treated organism Genetic modification
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
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).
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
Only notified under the "contained use" procedure. Dossier submitted on 01/02/2005. A Controlled, Randomised, Parallel Group, Multicentre Study of the Efficacy and Safety of Herpes Simplex Virus-Thymidine Kinase Gene Therapy (CereproTM), with Subsequent Ganciclovir, for the Treatment of Patients with Operable High-Grade Glioma Ark Therapeutics Ltd Humans Thymidine Kinase (HSV-TK1)
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