1. catapult cell therapy
  2. pfizer
  3. institut de recherches internationales servier
  4. schering plough nv/sa
  5. rhone-poulenc rorer
  6. glaxo wellcome
  7. Search the database for deliberate release of GM medicinal products

Search the database for deliberate release of GM medicinal products

Displaying 1 - 10 of 10
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B/BE/20/BVW6 Dossier withdrawn by the notifier Pfizer Humans Non-replicating recombinant vector derived from adeno-associated virus AAV6 serotype, containing a codon-optimised version of the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 24/04/2017. A Phase 1, Open Label, Non-comparative Study to Evaluate the Safety and the Ability of UCART19 to Induce Molecular Remission in Paediatric Patients With Relapsed/Refractory B Acute Lymphoblastic Leukaemia Institut de Recherches Internationales Servier Humans chimeric antigen receptor and suicide-ligand (RQR8)
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)
Only notified under the "contained use" procedure. Dossier submitted on 13/10/2000. A phase III open-label, comparative, multicentre trials to test the concept of durable virologic suppression in subjects with primary HIV-1 infection after intensive induction of quadruple HAART followed by double-blind randomization to HIV vaccination wi Glaxo Wellcome Humans vCP-1452
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 09/06/1998. 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 18/08/1997. A phase II gene therapy study in patients with non-small cell lung cancer using SCH58500 (rAd/p53) in combination with chemotherapy for multiple cycles Schering Plough NV/SA Humans Wild-type p53
Only notified under the "contained use" procedure. Dossier submitted on 21/10/1996. 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