-- Study meets primary endpoint: ProSavin® is safe, well-tolerated and mediates long-term improvement of motor function --
Oxford, UK – 16 April 2012: Oxford BioMedica plc (“Oxford BioMedica” or “the Company”) (LSE: OXB), the leading gene-based biopharmaceutical company, today announces that it has successfully completed a Phase I/II study to assess the safety, efficacy and dose evaluation of ProSavin® in patients with mid-stage Parkinson’s disease (PD) who are experiencing reduced benefit on L-DOPA "equivalent" therapy.
The study evaluated three ascending dose levels (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 which facilitates higher dosing and reduces surgery time. 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 Addenbrookes Hospital in Cambridge, UK with Dr Roger Barker as Principal Investigator.
The primary endpoint of the Phase I/II study is safety, and the secondary endpoint is efficacy as measured by the Unified Parkinson’s Disease Rating Scale (UPDRS) assessment at six months. All six patients in the fourth and final cohort have reached their six-month assessment time point, the results of which have been independently verified.
Highlights of fourth cohort at six months (n=6 at 5x dose, enhanced administration)
1. Motor function is assessed according to the UPDRS in patients’ “OFF” state (i.e. after withdrawal of PD medication).
In summary, ProSavin® has demonstrated a long-term safety profile, now up to 48 months post-treatment for the first two patients treated with a 1x dose. All 15 patients treated have shown an improvement in motor function at the six-month efficacy endpoint relative to baseline. As previously announced on 15 December 2011, population analysis of the first nine patients (cohorts 1-3) revealed that ProSavin® significantly improves motor function relative to baseline, with improvements remaining statistically significant up to 12 months post-treatment. The study’s independent Data Monitoring Committee also confirmed that the signals of improvements in motor function with decreased oral dopaminergic therapy observed to date are encouraging, particularly at the 5x dose.
John Dawson, Chief Executive Officer of Oxford BioMedica, said: "ProSavin® is the first lentiviral vector-based treatment for Parkinson's disease to be evaluated in a European clinical trial and the positive Phase I/II data set provides a solid basis for further clinical development. We are currently evaluating a more potent formulation of ProSavin® to ensure the greatest chance of success in randomised Phase II studies and increase the commercial opportunity for this novel product.”
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Notes to editors
About Oxford BioMedica®
Oxford BioMedica (LSE:OXB) is a leading gene and cell therapy company focused on developing life changing treatments for serious diseases. Oxford BioMedica and its subsidiaries (the “Group”) have built a sector leading lentiviral vector delivery platform (LentiVector®) through which the Group develops in vivo and ex-vivo products both in-house and with partners. The Group has created a valuable proprietary portfolio of gene and cell therapy product candidates in the areas of oncology, ophthalmology and CNS disorders. The Group has also entered into a number of partnerships, including with Novartis, Sanofi, GSK, and Immune Design, through which it has long-term economic interests in other potential gene and cell therapy products. Oxford BioMedica is based across several locations in Oxfordshire, UK and employs more than 250 people. Further information is available at www.oxfordbiomedica.co.uk.
For further information please contact
Oxford BioMedica plc
John Dawson, Chief Executive Officer
Stuart Paynter, Chief Financial Officer
Tel: +44 (0)1865 783 000
Consilium Strategic Communications – Media Enquiries
Mary-Jane Elliott/Matthew Neal/Philippa Gardner/Laura Thornton/Rosie Phillips
Tel: +44 (0)20 3709 5700