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/26/BVW3 A phase I/II/III study with a dose determination part followed by an efficacy and safety evaluation, quadruple blind placebo-controlled part and then by a long-term safety follow up part, in ambulant boys with Duchenne Muscular Dystrophy GENETHON Humans Non-replicating recombinant vector derived from adeno-associated virus AAV, lacking all AAV viral genes and carrying the human dystrophin (hMD1) gene
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 . A phase III, multi-center, open-label, randomized study to compare the effectiveness and safety of intratumoral administration of INGN 201 in combination with chemotherapy versus chemotherapy alone in 288 patients with recurrent squamous cell carcinoma of Introgen Therapeutics, Inc. Humans Wild-type p53

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