Oxford, UK – 5 May 2015: Oxford BioMedica plc (LSE: OXB) (“the Group”), a leading gene and cell therapy group, today announces that Professor Stéphane Palfi MD, PhD has presented a summary of the results from the 12 months and long term (three years) follow up of the 15 patients in the Phase I/II study of ProSavin®, a lentiviral vector based treatment for advanced Parkinson’s disease. Professor Palfi gave an oral presentation of the results at the American Association of Neurological Surgeons (AANS) conference on 4 May 2015 in Washington DC, USA.
The Phase I/II study was designed to evaluate the safety and tolerability of ProSavin® for the treatment of advanced Parkinson’s disease at numerous time points including one, three, six, nine, 12 and 36 months post single injection. ProSavin® was administered to 15 patients by MRI-guided stereotactic injection to the striatum. The study consisted of three dose cohorts.
As previously announced, and as reported in The Lancet in January 2014, ProSavin® met the endpoint of safety and tolerability at all dose levels. A significant improvement in mean unified Parkinson’s disease rating scale (UPDRS) part III motor scores in the off medication was observed at six and 12 months compared to baseline in all patients, and this was sustained in the majority of patients for up to three years in the long-term follow up analysis in this progressively degenerative disease. The open-label follow-up study is running to assess long-term (up to 9 years) safety data. The data supports the continued development of an enhanced construct of ProSavin®, OXB-102, as a treatment for advanced Parkinson’s disease.
John Dawson, Chief Executive Officer of Oxford BioMedica, said:
“This summarised data demonstrates that our LentiVector® platform can safely and effectively deliver genes over a long period for the treatment of Parkinson’s disease, resulting in clinical benefit. We are pleased that Professor Palfi presented this Phase I/II study data at 12 months and three years at the prestigious neurosurgical AANS conference.”
Commenting on the three year data, Professor Stéphane Palfi said:
“The continued safety profile of ProSavin® at three years follow-up for all patients and the signs of long-term benefit are still very encouraging in this neurodegenerative disease.”
Lancet. 2014 Mar 29;383(9923):1138-46. doi: 10.1016/S0140-6736(13)61939-X. Epub 2014 Jan 10.