Search the database for deliberate release of GM medicinal products

Displaying 1 - 7 of 7
EU record number Title Company / Sponsor Treated organism Genetic modification
B/BE/20/BVW6 Dossier withdrawn by the notifier Pfizer Humans Non-replicating recombinant vector derived from adeno-associated virus AAV6 serotype, containing a codon-optimised version of the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
EBOVEU001 A phase IIa partial blind, placebo-controlled clinical trial to evaluate the safety and immunogenicity of the Ad5-EBOV in healthy adults aged between 18 and 60 years in Belgium. Bejing Institute of Biotechnology, CanSino Biologics Inc, Humans Recombinant Adenoviral vector serotype 5 expressing the envelop glycoprotein from Ebola virus (Zaïre-Makona)
B/BE/18/BVW6 Global study of a recombinant adeno-associated virus designed to address the monogenic root cause of Spinal Muscular Atrophy AveXis Humans Recombinant adeno-associated virus serotype 9 (AAV9) containing the cDNA of the human SMN (Survival Motor Neuron) gene
B/BE/18/BVW5 A Phase 1b/2a study to assess the safety and tolerability of GM Lactococcus lactis in subjects with Type 1 Diabetes Mellitus Intrexon T1D Partners, LLC Humans Biologically contained strain of Lactococcus lactis, genetically modified to secrete human interleukin-10 and proinsulin
B/BE/18/BVW3 A phase 2 study to assess the safety and efficacy of GM Lactococcus lactis for the attenuation of oral mucositis in subjects with cancers of the head and neck Oragenics, Inc. Humans Biologically contained strain of Lactococcus lactis, genetically modified to secrete human Trefoil Factor 1 (hTFF1).
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)