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 |
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B/BE/25/BVW5 | GenePHIT: A study to learn more about how well a new gene therapy (AB-1002) works and its safety in participants with congestive heart failure | Asklepios BioPharmaceutical (AskBio) | Humans | Non-replicating recombinant vector derived from adeno-associated virus AAV2i8 carrying the transgene encoding for the human activated Inhibitor-1c ( I-1c) |
B/BE/25/BVW3 | Phase 3, Open-label, Single-dose Study of CSL222 in Adolescent Male Subjects (≥ 12 to < 18 Years of Age) with Severe or Moderately Severe Hemophilia B | CSL Behring LLC | Humans | Recombinant adeno associated viral vector containing the codon-optimised human PADUA factor IX (FIX) gene |
Only notified under the "contained use" procedure. Dossier submitted on 04/10/2018. | A Phase 3, Randomized, Double-blind, Placebo-controlled study to Determine the Efficacy and Safety of CMB305 in Unresectable Locally-advanced or Metastatic NY-ESO-1 + Synovial Sarcoma Subjects Following First-line Systemic Anti-cancer Therapy | Immune Design | Humans | Replication deficient lentiviral vector encoding NY-ESO-1 cancer testis antigen |