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 Oxford BioMedica Announces Two-year Phase I/II Results of ProSavin® In Parkinson's Disease - 14/06/20102010/OB/12
Two-Year Data Show Sustained Improvement in Patients Oxford, UK – 14 June 2010: Oxford BioMedica (LSE: OXB), a leading gene therapy
company, announced today new data from the ongoing Phase I/II trial of ProSavin®, its novel gene therapy for the treatment of Parkinson’s disease. Following treatment with ProSavin, the follow-up data suggest that patients continued to benefit from ProSavin after two years and that ProSavin was safe and well tolerated. The Principal Investigator, Professor Stéphane Palfi, of the Henri Mondor Hospital in Paris, presented the updated results at the 9th Annual Congress of the French Society of Cell and Gene Therapy, Paris, France, yesterday.
Highlights:
Patients at the first two dose levels have been assessed at one year and two years following their treatment with ProSavin. There have been no safety issues related to the product, patients remain well and there has been no evidence of immune or other toxicities.
The first cohort of patients, treated at the lowest initial dose level, have completed two-year assessments. The mean improvement from baseline in UPDRS III “OFF” score was 20%, in two of the three patients sustained effects of 30% improvement were observed without any increase in L-DOPA dose. The third patient did not respond so markedly to ProSavin and remained at levels of improvement similar to baseline however is in good health and will continue in the study. The maximum improvement in motor function at one year was 56% in the second (higher) dose group and the mean was 28% for both doses relative to the patients’ pre-treatment motor function.
The two year follow-up results are comparable to improvements seen with deep brain stimulation and are therefore approaching levels which would justify taking ProSavin into a randomised study and towards registration. Furthermore, continued improvements in quality of life have been shown as measured by the PDQ 39 questionnaire (the most widely used measure of health status in Parkinson's Disease) in all patients in this cohort. Parkinson’s disease is a progressive neurodegenerative disorder and deterioration of symptoms and increases in daily L-DOPA dose would be expected over a two-year period.
These sustained improvements are unlikely to be due to any placebo effect. The patients have either had their L-DOPA therapy stabilised or reduced by up to 40% following treatment with ProSavin. This finding is what Oxford BioMedica would have expected to see if ProSavin was functioning to establish a new dopamine factory in the patients’ brains. These data further support ProSavin having long-term benefit in the clinical setting, treating the primary symptoms of Parkinson’s Disease as well as reducing the severe side effects of long term LDOPA therapy.
Given these promising results, Oxford BioMedica has received regulatory approval to use a modified administration procedure that will reduce surgery time and, subject to DSMB approval, to escalate the dose. This strategy has been fully supported by the ProSavin Scientific Advisory Board and the study’s Data Monitoring Committee. The new administration procedure requires fewer needle tracks and, based on pre-clinical experiments, it may enhance the efficacy of ProSavin. Furthermore, the reduced surgery time with the new method could accelerate overall development and expand the market opportunity.
Professor Stéphane Palfi commented: "We are particularly satisfied by the long term safety profile of ProSavin together with the sustained effects in patients. This strongly encourages us to go forward in the dose escalation phase with the new method of administration."
John Dawson, Oxford BioMedica’s Chief Executive Officer, added: “We are pleased with this two-year follow-up data which further demonstrates that ProSavin is both safe and effective for improving the quality of life of patients suffering with Parkinson’s disease even at these initial low doses. We are excited about the forthcoming dose escalation, which utilises the new administration method, which could further enhance efficacy and would therefore increase the product’s value as we move forward in clinical development. We continue our negotiations around ProSavin with prospective partners from a strengthened position.”
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