Search the database for deliberate release of GM medicinal products

Displaying 1 - 11 of 11

EU record number	Title	Company / Sponsor	Treated organism	Genetic modification
B/BE/21/BVW9	Dossier withdrawn by the notifier	ActoGenix	Humans	V181 is a live attenuated dengue quadrivalent vaccine rDENVΔ30 where the four viral components of V181 (one for each serotype) present a deletion of 30 nucleotides in the 3’ non‐coding region (Δ30)
Only notified under the "contained use" procedure. Dossier submitted on 24/04/2018.	A Phase 2a Randomized, Double-blind, Placebo-controlled rial to Assess the safety, Immunogenicity, and Efficacy of the Recombinant MVA-BN-RSV Vaccine against Respiratory Syncytial Virus Infection in the Virus Challenge Model in Healthy Adult Volunteers	Bavarian Nordic A/S	Humans	Vaccinia virus Ankara strain expression glycoproteins of different RSV strain (MVA-BN)
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 07/04/2014.	A single-center, open-label Phase 1 study to assess safety and medical endoscopic sampling methodology and to characterize the pharmacokinetics of oral doses of AG014 in Healthy Subjects	ActoGenix	Humans	gene expressing certolizumab
Only notified under the "contained use" procedure. Dossier submitted on 08/05/2012.	A single-center, open-label Phase 1 study to assess the effect of food/beverage and to characterisze the pharmacokinetics of single and multiple oral doses of AG013 in Healthy Subjects	ActoGenix	Humans	Human Trefoil Factor 1
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)
B/BE/08/BVW1	MI-CP178: Study of a Live, Attenuated Intranasal Vaccine Against Respiratory Syncytial Virus (RSV) and Parainfluenza Virus Type 3 (PIV3), in Healthy 6 to < 24 Month-Old Children and in 2 Month-Old Infants	MedImmune LLC	Humans	Genes of the human Parainfluenza virus fusion (F) and hemagglutinin-neuraminidase (HN) proteins; gene of the human Respiratory syncitial virus fusion protein (RSV F).
B/BE/04/BV1	Evaluation of the safety of Feline Herpes Virus, bivalent deleted live vaccine, administered as intranasal vaccine to cats	Pfizer, Animal Health Group	cats	gene for the env glycoprotein or gene for the gag protein of the Feline immunodeficiency virus (FIV)
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 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