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/12/BVW2
Clinical trial evaluating the safety and efficacy of intracoronary administration of MYDICAR (AAV1/SERCA2a) in subjects with heart failure
Celladon
Humans
Human SERCA2a:CA++ pump involved in the regulation of heart contraction/relaxation cycle
B/BE/12/BVW1
A multi-center, randomized, double-blind, placebo-controlled Phase I/II trial to compare the safety, tolerability and immunogenicity of the therapeutic THV01 vaccination of HIV-1 clade B infected patients under highly antiretroviral therapy
TheraVectys
Humans
genes encoding the epitopes of the HIV-1 Gag, Pol and Nef proteins
Only notified under the "contained use" procedure. Dossier submitted on 8 May, 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 23 April, 2012
.
Randomized Phase III of haploidentical HCT with or without an add back strategy of HSV-Tk donor lymphocytes in patients with high risk acute leukemia
Molmed S.p.A.
Humans
-Thymidine Kinase (HSV-Tk)
- selection marker
B/BE/04/BV1
Evaluation of the safety of Feline Herpes Virus, bivalent deleted live vaccine, administered as intranasal vaccine to cats
Pfizer, Animal Health Group
cats
gene for the env glycoprotein or gene for the gag protein of the Feline immunodeficiency virus (FIV)