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/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) |
| B/BE/98/B6 |
Clinical research program : Gene-therapy by the Use of a Recombinant Adenovirus in the Treatment of p53 Deficient Cancers |
Schering Plough NV/SA |
Humans |
wild-type p53 tumor suppressor gene |
| Only notified under the "contained use" procedure. Dossier submitted on
. |
A phase II, multi-center, open label, randomized study to evaluate biodistribution and transmission, effectiveness and safety of two treatment regimens of Ad5CMV-p53 administered by intra-tumoral injections in 40 evaluable patients with advanced squamous |
Rhone-Poulenc Rorer |
Humans |
Wild-type p53 |
| Only notified under the "contained use" procedure. Dossier submitted on
. |
Phase II randomized study of immunotherapy of advanced breast cancer by repeated intramuscular injection of a recombinant vaccinia virus containing sequences coding for human MUC-1 and interleukin-2 (TG1031) comparing two doses levels |
Transgene |
Humans |
Muc-1 and Interleukine 2 (IL-2) |
| Only notified under the "contained use" procedure. Dossier submitted on
. |
Pilot study of immunization with recombinant canarypox virus vCP1469A expressing the MAGE-1.A1 and MAGE-3.A1 cytolytic T lymphocytes epitopes in patients with malignant melanoma, non-small cell lung carcinoma, head-and-neck squamous cell carcinoma, esopha |
Pasteur Mérieux Connaught |
Humans |
HLA-A1 restricted CTL epitope of MAGE-1 and
MAGE-3 genes |
