Search the database for deliberate release of GM medicinal products
Displaying 1 - 3 of 3
| EU record number | Title | Company / Sponsor | Treated organism | Genetic modification |
|---|---|---|---|---|
| B/BE/25/BVW7 | A Randomized, Controlled, Partially Masked, Phase 3b Study to Assess the Injection Burden, Efficacy, Safety, and Long-Term Preservation of Visual Acuity of Surabgene Lomparvovec (ABBVRGX-314) in a Real-World Context in Subjects with Neovascular Age-Relate | AbbVie Deutschland GmbH & Co. KG | Humans | Non-replicating recombinant vector derived from adeno-associated virus AAV8 carrying the human anti-vascular endothelial growth factor (VEGF) antigen-binding fragment. |
| B/BE/19/BVW2 | A Phase 3 Open-Label, Single-Arm Study To Evaluate The Efficacy and Safety of BMN 270, an Adeno-Associated Virus Vector–Mediated Gene Transfer of Human Factor VIII in Hemophilia A Patients with Residual FVIII Levels Receiving Prophylactic FVIII | BioMarin Pharmaceutical Inc. | Humans | Recombinant adeno-associated virus serotype 5 (AAV5) containing a gene cassette expressing the human coagulation factor VIII (FVIII) gene |
| Only notified under the "contained use" procedure. Dossier submitted on 20/08/2015. | A single arm Phase I/II study of the safety and efficacy of gene-modified WT1 TCR therapy in patients with myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) | Catapult Cell Therapy | Humans | Expression of the Wilms' tumour antigen 1 (WT1)- specific T cell receptor (TCR) |