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Publication of ProSavin Phase I/II Study
Publication of ProSavin Phase I/II Study.
About this update from Oxford Biomedica Plc
[{"type":"text","content":"\n \nRNS Number : 3363X Oxford Biomedica PLC 10 January 2014 \n\n \n \n \n \n \n \nOxford BioMedica Announces Publication of ProSavin® Phase I/II Study in The Lancet \n \n-- Pioneering data published in world-leading, peer-reviewed medical journal --\n \n-- ProSavin® has demonstrated favourable safety, tolerability and long-term improvement of motor function in advanced Parkinson's disease --\n \nOxford, UK - 10 January 2014: Oxford BioMedica plc (\"Oxford BioMedica\" or \"the Company\") (LSE: OXB), the leading gene-based biopharmaceutical company, today announces the online publication of results from the previously reported ProSavin® Phase I/II study in patients with advanced Parkinson's disease (PD) in The Lancet. According to the key published findings in The Lancet, ProSavin® has demonstrated a favourable safety profile and a statistically significant improvement in motor function relative to baseline at six and 12 months post-treatment. \n \nThe paper, entitled \"Long-term safety and tolerability of ProSavin®, a lentiviral vector-based gene therapy for Parkinson's disease: a dose escalation open label phase I/II trial\", can be accessed via http://www.thelancet.com/journals/lanres/article/PIIS2213-2600(13)70234-0/abstract.\n \nStudy design\nThe study evaluated three ascending dose levels of ProSavin® (1x, 2x and 5x) in a total of 15 patients with PD. Six patients received the 2x dose, the latter three of which were treated using an enhanced administration procedure. Six patients received the highest 5x dose. Patients were treated at two centres of excellence for neurosurgery: the Henri Mondor Hospital in Paris, France with Professor Stéphane Palfi as Principal and Coordinating Investigator, and at Addenbrooke's Hospital in Cambridge, UK with Professor Roger Barker as Principal Investigator. The primary endpoints of the Phase I/II study were safety and efficacy as measured by the Unified Parkinson's Disease Rating Scale (UPDRS) assessment at six months.\n \nHighlights from the Phase I/II study\n· Safety: ProSavin® has demonstrated a favourable safety profile with no serious adverse events, related to ProSavin® or the surgical procedure, observed to date.\n \n· ...