Search the database for deliberate release of GM medicinal products

Displaying 1 - 14 of 14

EU record number	Title	Company / Sponsor	Treated organism	Genetic modification
B/BE/22/BVW4	A Phase I/II, Multicenter, Open-Label Study of Nous-209 Genetic Vaccine for the Treatment of Microsatellite Unstable Solid Tumors	Nouscom Srl	Humans	The study involves two GMOs: (i) A replication-incompetent adenovirus (GAd20 with deletions of the viral E1, E3 and E4 coding regions) isolated from a gorilla and encoding the FSP neoantigens; (ii) an attenuated, replication-defective orthopoxvirus (Modified Vaccinia virus Ankara), encoding for the same neoantigens.
B/BE/21/BVW9	Dossier withdrawn by the notifier	ActoGenix	Humans	V181 is a live attenuated dengue quadrivalent vaccine rDENVΔ30 where the four viral components of V181 (one for each serotype)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)
B/BE/21/BVW4	An Open-Label, Multicenter, Non-Randomized, Dose-Confirmation and Cohort-Expansion Phase 1b Study to Evaluate the Safety, Tolerability, and Anti-Tumor Activity of ATP128, VSV-GP128 and BI 754091, in Patients with Stage IV Colorectal Cancer	AMAL Therpeutics	Humans	VSV-GP128 is a recombinant live-attenuated Vesicular Stomatitis Virus (VSV), modified to minimize the potential of neurotoxicity for humans and skin disease in animals, and engineered to contain cancer antigens, which help it induce an immune response against colorectal tumour cells.
B/BE/20/BVW5	Phase 1b Study to Evaluate the Safety, Tolerability, and Anti-Tumor Activity of Nous-PEV, with pembrolizumab, in Patients with Unresectable Stage III / IV Cutaneous Melanoma and with Stage IV NSCLC	Nouscom Srl	Humans	The study involves two GMOs: (i) A replication-incompetent adenovirus (GAd20 with deletions of the viral E1, E3 and E4 coding regions) isolated from a gorilla and encoding the PEV neoantigens gene; (ii) an attenuated, replication-defective orthopoxvirus (Modified Vaccinia virus Ankara), encoding for the neoantigens gene.
B/BE/19/BVW3	A Phase 1, Multi-center, Open-label, Dose De-escalation Study to Evaluate the Safety and efficacy of Talimogene Laherparepvec in Pediatric Subjects With Advanced Noncentral Nervous System Tumors That are Amenable to Direct Injection	Amgen Ltd	Humans	Insertion of a gene expressing granulocyte-macrophage colony-stimulating factor (hGM-CSF) - Functional deletion of two genes (ICP34.5 and ICP47) of the HSV-1 genome
B/BE/17/BVW2	A Phase 1b Study of Talimogene Laherparepvec in Combination With Atezolizumab in Subjects With Triple Negative Breast Cancer and Colorectal Cancer With Liver Metastases	Amgen Ltd	Humans	Insertion of a gene expressing granulocyte-macrophage colony-stimulating factor (hGM-CSF) - Functional deletion of two genes (ICP34.5 and ICP47) of the HSV-1 genome
B/BE/16/BVW1	A Phase 1, Multicenter, Open-label Trial to Evaluate the Safety of Talimogene	Amgen Ltd	Humans	Insertion of a gene expressing granulocyte-macrophage colony-stimulating factor (hGM-CSF) - Functional deletion of two genes (ICP34.5 and ICP47) of the HSV-1 genome
B/BE/15/BVW2	A Phase 1b/3, Multicenter, Open-label Trial of Talimogene Laherparepvec in Combination With Pembrolizumab for Treatment of Subjects With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (20130232)	Amgen Ltd	Humans	Insertion of a gene expressing granulocyte-macrophage colony-stimulating factor (hGM-CSF) - Functional deletion of two genes (ICP34.5 and ICP47) of the HSV-1 genome
B/BE/15/BVW1	A Phase 1b/3, Multicenter, Open-label Trial of Talimogene Laherparepvec in Combination With Pembrolizumab (MK-3475) for Treatment of Unresected, Stage IIIB to IVM1c Melanoma	Amgen Ltd	Humans	Insertion of a gene expressing granulocyte-macrophage colony-stimulating factor (GM-CSF) - Functional deletion of two genes (ICP34.5 and ICP47) of the HSV-1 genome
B/BE/14/BVW1	A phase 2 clinical trial with Talimogene Laherparepvec	Amgen Ltd	Humans	Insertion of a gene expressing granulocyte-macrophage colony-stimulating factor (GM-CSF) - Functional deletion of two genes (ICP34.5 and ICP47) of the HSV-1 genome
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
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 24/10/1996.	Prospective, open-label, parallel-group, randomized, multicenter trial comparing the efficacy of surgery, radiation, and injection of murine cells producing herpes simplex thymidine kinase vector followed by intravenous ganciclovir against the efficacy of	Genetic therapy, Inc., Sandoz Pharma, Ltd	Humans	Thymidine Kinase (HSV-TK1), neomycin resistance (NeoR)