Search the database for deliberate release of GM medicinal products

Displaying 1 - 6 of 6

EU record number	Title	Company / Sponsor	Treated organism	Genetic modification
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 14/10/2015.	A phase II, single-arm, multi-center trial to determine the efficacy and safety of CTL019 in pediatric patients with relapsed and refractory B-cell acute lymphoblastic leukemia	Novartis Pharma Services AG	Humans	Chimeric antigen receptor against CD19
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/07/BVW3	A multi-centre phase I study to evaluate the safety and tolerability of a heterologous prime-boost vaccination with INX102-3697 HBV pDNA/INX102-0557 HBV MVA in healthy volunteers and HBeAg+ chronic hepatitis patients	GENimmune N.V.	Humans	Hepatitis B virus polyepitope gene
B/BE/07/BVW1	Phase 1b and Phase 2a clinical trials with an hIL-10-expressing Lactococcus lactis	ActoGeniX N.V.	Humans	Gene coding for the human interleukin-10 (hIL-10)
Only notified under the "contained use" procedure. Dossier submitted on 09/06/1998.	A phase II, multi-center, open label, randomized study to evaluate biodistribution and transmission, effectiveness and safety of two treatment regimens of Ad5CMV-p53 administered by intra-tumoral injections in 40 evaluable patients with advanced squamous	Rhone-Poulenc Rorer	Humans	Wild-type p53