Search the database for deliberate release of GM medicinal products
EU record number
Title
Company / Sponsor
Treated organism
Genetic modification
Only notified under the "contained use" procedure. Dossier submitted on 25 March 2025
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EXACT 2 is a randomized, multicenter, double-blind, placebo-controlled Phase 2b trial designed to evaluate the safety, feasibility, and efficacy of percutaneous endovascular catheter-facilitated intramyocardial administration of XC001 in patients with ref XyloCor Therapeutics
Humans
VEGF
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Dossier withdrawn by the notifier Pfizer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
B/BE/09/BVW1
A randomized, double blind, placebo controlled, parallel group, multicenter study of the safety and response rate of 3 subcutaneously administered doses of 5 x 10^7 pfu RO5217790 in patients with high grade cervical intraepithelial neoplasia grade 2 N.V. Roche S.A.
Humans
E6 and E7 genes of the HPV16 virus and gene of the human Interleukin-2 (hIL2)
