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 |
|---|---|---|---|---|
| Only notified under the "contained use" procedure. Dossier submitted on 18/02/2020. | A phase III, randomized observer blinded, placebo-controlled, multi-center study, to evaluate safety and immunogenicity of the Chikungunya vaccine MV-CHIK in healthy adults | Themis Bioscience GmbH | Humans | Recombinant measles virus vaccine strain (Schwarz strain) expressing env (E1, E2, E3), capsid C en structural protein 6K from CHIKV |
| B/BE/19/BVW4 | Importation of doses of V920 for Emergency Use | Merck Sharp & Dohme B.V. | Humans | Recombinant Vesicular Stomatitis Virus (rVSV) in which the gene encoding for the VSV glycoprotein G has been deleted and replaced with the gene encoding the Zaire Ebola virus (ZEBOV) glycoprotein (GP). |
| 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 |
| Only notified under the "contained use" procedure. Dossier submitted on 23/07/2019. | A phase 1, randomized, placebo-controlled trial, to evaluate the optimal dose of MV-LASV, a new vaccine against LASSA virus infection, regarding safety, tolerability and immunogenicity in healthy volunteers, consisting of an unblinded dose escalation and | Themis Bioscience GmbH | Humans | Recombinant measles virus vaccine strain (Schwarz strain) expressing the envelop glycoprotein GPC and the nucleoprotein NP with a mutated exonuclease domein (GCP-rNP) from Lassavirus |
| Only notified under the "contained use" procedure. Dossier submitted on 20/08/2018. | A Phase I/II study of the safety and efficacy of a single dose of autologous CRISPR-Cas9 modified CD34+ human hematopoietic stem and progenitor cells in subjects with severe sickle disease | CRISPR Therapeutic AG | Humans | Modified cells expressing Hemoglobin F (HbF) |
| 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 11/07/2002. | A European and Canadian multicenter, randomized, double-blind, placebo controlled study to evaluate the efficacy and safety of Ad5FGF-4 in patients with stable angina | Schering N.V./S.A. | Humans | human FGF-4 |