1. international aids vaccine initiative (iavi)
  2. vion pharmaceuticals, inc.
  3. actogenix n.v.
  4. pfizer
  5. wageningen bioveterinary research (larissa consortium)
  6. amal therpeutics
  7. Search the database for deliberate release of GM medicinal products

Search the database for deliberate release of GM medicinal products

Displaying 1 - 9 of 9
EU record number Title Company / Sponsor Treated organism Genetic modification
B/BE/24/BVW5 Phase 3, open-label, single-arm study to evaluate efficacy and safety of FIX gene transfer with PF-06838435 (rAAV-Spark100-hFIX-R338L) in adult male participants with moderately severe to severe hemophilia B (FIX:C ≤2%) (BeneGene-2) Pfizer Humans Recombinant adeno associated viral vector containing the codon-optimised human factor IX (FIX) minigene (R338L variant)
​B/BE/21/BVW4 An Open-Label, Multicenter, Non-Randomized, Dose-Confirmation and Cohort-Expansion Phase 1b Study to Evaluate the Safety, Tolerability, and Anti-Tumor Activity of ATP128, VSV-GP128 and BI 754091, in Patients with Stage IV Colorectal Cancer AMAL Therpeutics Humans VSV-GP128 is a recombinant live-attenuated Vesicular Stomatitis Virus (VSV), modified to minimize the potential of neurotoxicity for humans and skin disease in animals, and engineered to contain cancer antigens, which help it induce an immune response against colorectal tumour cells.
B/BE/21/BVW2 Phase I study to assess safety, tolerability and immunogenicity of the hRVFV-4s vaccine in healthy subjects Wageningen Bioveterinary Research (Larissa Consortium) Humans hRVFV-4s is a four segments human Rift Valley fever virus vaccine, which derives from a natural clone (Clone 13) that lacks 69% of the gene NSs, a major virulence determinant of the virus. The hRVFV-4s vaccine is further attenuated by splitting the M genome segment into two M-type segments.
B/BE/20/BVW6 Dossier withdrawn by the notifier Pfizer Humans Non-replicating recombinant vector derived from adeno-associated virus AAV6 serotype, containing a codon-optimised version of the human Factor VIII gene
B/BE/20/BVW4 A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of PF-06939926 for the Treatment of Duchenne Muscular Dystrophy Pfizer Humans Non-replicating recombinant vector derived from adeno-associated virus AAV9, lacking all AAV viral genes and containing a miniaturized version of the human dystrophin 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)
B/BE/07/BVW1 Phase 1b and Phase 2a clinical trials with an hIL-10-expressing Lactococcus lactis ActoGeniX N.V. Humans Gene coding for the human interleukin-10 (hIL-10)
Only notified under the "contained use" procedure. Dossier submitted on 10/06/2003. 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
Only notified under the "contained use" procedure. Dossier submitted on 25/06/1999. A phase I feasibility trial of a live, genetically modified Salmonella typhimurium bacillus (VNP20009) for the treatment of cancer by intra-tumoral injection Vion Pharmaceuticals, Inc. Humans Not relevant