According to Oxford BioMedica, 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.
Oxford BioMedica said that 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.
The 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. The 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.
Stephane Palfi, professor of the Henri Mondor Hospital in Paris, said: “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, chief executive officer of Oxford BioMedica, said: “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.”