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/21/BVW7	Phase I open-label, dose escalation trial of BI 1831169 monotherapy and in combination with ezabenlimab in patients with advanced or metastatic solid tumors	SCS Boehringer Ingelheim Comm.V	Humans	BI 1831169 is a recombinant live-attenuated Vesicular Stomatitis Virus (rVSV), modified to replace the VSV-G glycoprotein with the Lymphocytic Choriomeningitis Virus glycoprotein in order to minimize the potential of neurotoxicity for humans and skin disease in animals.
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)
B/BE/12/BVW1	A multi-center, randomized, double-blind, placebo-controlled Phase I/II trial to compare the safety, tolerability and immunogenicity of the therapeutic THV01 vaccination of HIV-1 clade B infected patients under highly antiretroviral therapy	TheraVectys	Humans	genes encoding the epitopes of the HIV-1 Gag, Pol and Nef proteins
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)
Only notified under the "contained use" procedure. Dossier submitted on 01/02/2005.	A Controlled, Randomised, Parallel Group, Multicentre Study of the Efficacy and Safety of Herpes Simplex Virus-Thymidine Kinase Gene Therapy (CereproTM), with Subsequent Ganciclovir, for the Treatment of Patients with Operable High-Grade Glioma	Ark Therapeutics Ltd	Humans	Thymidine Kinase (HSV-TK1)
Only notified under the "contained use" procedure. Dossier submitted on 02/01/1996.	Gene therapy for the treatment of glioblastoma multiforme with in vivo tumor transduction with the herpes simplex thymidine kinase gene /ganciclovir system	Sandoz Pharma, LTD		Thymidine Kinase (HSV-TK1), neomycin resistance (NeoR)