Search the database for deliberate release of GM medicinal products
| EU record number |
Title |
Company / Sponsor |
Treated organism |
Genetic modification |
| 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
. |
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
. |
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/09/BVW1 |
A randomized, double blind, placebo controlled, parallel group, multicenter study of the safety and response rate of 3 subcutaneously administered doses of 5 x 10^7 pfu RO5217790 in patients with high grade cervical intraepithelial neoplasia grade 2 |
N.V. Roche S.A. |
Humans |
E6 and E7 genes of the HPV16 virus and gene of the human Interleukin-2 (hIL2) |
| B/BE/03/B3 |
Phase I multicentre study of TG1024 (Adenovirus interleukin 2) in patients with metastatic melanoma or other advanced solid tumor cancers |
Transgene S.A. |
Humans |
gene coding for human interleukin 2 |
| Only notified under the "contained use" procedure. Dossier submitted on
. |
A phase 1 randomized, placebo-controlled, double-blind, dose escalation trial to evaluate the safety and immunogenicity of tgAAC09, a gag-PR-DRT AAV HIV vaccine |
International AIDS Vaccine Initiative (IAVI) |
Humans |
genes for the gag, protease and part of the reverse transcriptase proteins of HIV-1 |
