Search the database for deliberate release of GM medicinal products
Displaying 1 - 7 of 7
| EU record number | Title | Company / Sponsor | Treated organism | Genetic modification |
|---|---|---|---|---|
| B/BE/21/BVW9 | Dossier withdrawn by the notifier | ActoGenix | Humans | V181 is a live attenuated dengue quadrivalent vaccine rDENVΔ30 where the four viral components of V181 (one for each serotype) present a deletion of 30 nucleotides in the 3’ non‐coding region (Δ30) |
| 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 |
| Only notified under the "contained use" procedure. Dossier submitted on 20/08/2018. | A Phase I/II study of the safety and efficacy of a single dose of autologous CRISPR-Cas9 modified CD34+ human hematopoietic stem and progenitor cells in subjects with severe sickle disease | CRISPR Therapeutic AG | Humans | Modified cells expressing Hemoglobin F (HbF) |
| 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 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 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) |