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Publication of RetinoStat® (OXB-201) Phase I study
Publication of RetinoStat® (OXB-201) Phase I study.
About this update from Oxford Biomedica Plc
[{"type":"text","content":"\n \nRNS Number : 0827M Oxford Biomedica PLC 10 October 2016 \n\n\n\nOxford BioMedica Announces Publication of Pioneering RetinoStat® (OXB-201) Phase I Study Data in the Journal, Human Gene Therapy\n \n-- RetinoStat® met its primary endpoint, demonstrating favourable safety and tolerability profiles\n \nOxford, UK - 10 October 2016: Oxford BioMedica plc (LSE:OXB) (\"Oxford BioMedica\" or \"the Group\"), a leading gene and cell therapy group, today announces the publication in the journal Human Gene Therapy of the previously announced ground-breaking results from the RetinoStat® (OXB-201) Phase I study in patients with advanced wet age-related macular degeneration (AMD) on 6 May 2016. According to key published findings in the associated peer-reviewed paper, RetinoStat® demonstrated a favourable safety profile and led to robust, reproducible sustained expression of endostatin and angiostatin in the eye.\n \nThe Phase I study was primarily designed to evaluate the safety and tolerability of RetinoStat® for the treatment of severe wet AMD following a single subretinal injection and represented the first time a lentiviral based vector had been administered to the human eye. Twenty-one subjects with highly fibrotic retinas who were refractory to anti-VEGF therapy following a prior responsive history were treated. As previously announced the results of the Phase I study indicated that RetinoStat® met the primary endpoint of safety and tolerability. Importantly, therapeutic gene expression, measured in these patients as a secondary study endpoint, was found to be dose-dependent and maintained at the last measurement (2.5 years in 8 subjects and >4 years in two subjects).\n \nPeter A. Campochiaro, the Eccles Professor of Ophthalmology and Neuroscience at the Wilmer Eye Institute was the lead author and principal and coordinating investigator. Andreas K. Lauer (Oregon Health Sciences Center of the University of Oregon) and Elliott H. Sohn (University of Iowa) were the other investigators of the study.\n \nThe online publication in Human Gene Therapy is entitled: \"Lentiviral Vector Gene Transfer of Endostatin/Angiostatin for Macular Degeneration (GEM) Study\". Please follow this link to read the paper in full: http://online.liebertpub.com/doi/full/10.1089/hum.2016.117\n \nHighlights from the Phase I...