Search the database for deliberate release of GM medicinal products
EU record number
Title
Company / Sponsor
Treated organism
Genetic modification
B/BE/14/BVW1
A phase 2 clinical trial with Talimogene Laherparepvec Amgen Ltd
Humans
Insertion of a gene expressing granulocyte-macrophage colony-stimulating factor (GM-CSF) - Functional deletion of two genes (ICP34.5 and ICP47) of the HSV-1 genome
Only notified under the "contained use" procedure. Dossier submitted on 7 April, 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
B/BE/07/BVW3
A multi-centre phase I study to evaluate the safety and tolerability of a heterologous prime-boost vaccination with INX102-3697 HBV pDNA/INX102-0557 HBV MVA in healthy volunteers and HBeAg+ chronic hepatitis patients GENimmune N.V.
Humans
Hepatitis B virus polyepitope gene
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 5 July, 2005
.
A multicenter, randomized, double-blind, placebo-controlled study evaluating the efficacy of Biobypass (ADGVVEGF121.10NH) delivered by NOGATM-guided/MYOSTARTM catheter in "no option" patients with class II-IV stable angina GenVec, Inc.
Humans
human VEGF121
Only notified under the "contained use" procedure. Dossier submitted on 1 February, 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)
