Search the database for deliberate release of GM medicinal products

Displaying 1 - 5 of 5
EU record number Title Company / Sponsor Treated organism Genetic modification
B/BE/21/BVW8 Phase 3 Randomized, Controlled Study of AAV5-hRKp.RPGR for the Treatment of X-linked Retinitis Pigmentosa Associated with Variants in the RPGR gene Meira GTx UK II Limited Humans Non-replicating recombinant vector derived from adeno-associated virus AAV 5 carrying the human RPGR gene
B/BE/21/BVW7 Phase I open-label, dose escalation trial of BI 1831169 monotherapy and in combination with ezabenlimab in patients with advanced or metastatic solid tumors SCS Boehringer Ingelheim Comm.V Humans BI 1831169 is a recombinant live-attenuated Vesicular Stomatitis Virus (rVSV), modified to replace the VSV-G glycoprotein with the Lymphocytic Choriomeningitis Virus glycoprotein in order to minimize the potential of neurotoxicity for humans and skin disease in animals.
Only notified under the "contained use" procedure. Dossier submitted on 18/02/2020. A phase III, randomized observer blinded, placebo-controlled, multi-center study, to evaluate safety and immunogenicity of the Chikungunya vaccine MV-CHIK in healthy adults Themis Bioscience GmbH Humans Recombinant measles virus vaccine strain (Schwarz strain) expressing env (E1, E2, E3), capsid C en structural protein 6K from CHIKV
Only notified under the "contained use" procedure. Dossier submitted on 23/07/2019. A phase 1, randomized, placebo-controlled trial, to evaluate the optimal dose of MV-LASV, a new vaccine against LASSA virus infection, regarding safety, tolerability and immunogenicity in healthy volunteers, consisting of an unblinded dose escalation and Themis Bioscience GmbH Humans Recombinant measles virus vaccine strain (Schwarz strain) expressing the envelop glycoprotein GPC and the nucleoprotein NP with a mutated exonuclease domein (GCP-rNP) from Lassavirus
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