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/02/B7 |
Phase II study evaluating the clinical efficacy of TG4010 (MVA-MUC1-IL2) in patients with metastatic Renal Cell Carcinoma (RCC) |
Transgene S.A. |
Humans |
sequences coding for the human MUC-1 antigen and IL-2 |
| Only notified under the "contained use" procedure. Dossier submitted on
. |
A European and Canadian multicenter, randomized, double-blind, placebo controlled study to evaluate the efficacy and safety of Ad5FGF-4 in patients with stable angina |
Schering N.V./S.A. |
Humans |
human FGF-4 |
| Only notified under the "contained use" procedure. Dossier submitted on
. |
Prospective, open-label, parallel-group, randomized, multicenter trial comparing the efficacy of surgery, radiation, and injection of murine cells producing herpes simplex thymidine kinase vector followed by intravenous ganciclovir against the efficacy of |
Genetic therapy, Inc., Sandoz Pharma, Ltd |
Humans |
Thymidine Kinase (HSV-TK1), neomycin resistance (NeoR) |
| Only notified under the "contained use" procedure. Dossier submitted on
. |
A phase I study in patients with recurrent or metastatic squamous cell carcinoma of the head and neck using SCH 58500 (rAd/p53) administered by single intratumoral injection |
Schering Plough NV/SA |
Humans |
Wild-type p53 |
| Only notified under the "contained use" procedure. Dossier submitted on
. |
Gene therapy for the treatment of glioblastoma multiforme with in vivo tumor transduction with the herpes simplex thymidine kinase gene /ganciclovir system |
Sandoz Pharma, LTD |
|
Thymidine Kinase (HSV-TK1), neomycin resistance (NeoR) |