Monday, 14 June 2010

Oxford BioMedica ProSavin treatment of Parkinson's provides continued benefits after 2 years

Gene therapy specialist Oxford BioMedica (LON:OXB) has reported that new data, from the ongoing Phase I/II trial of its ProSavin treatment of Parkinson's disease, suggests that patients continued to benefit from ProSavin after two years, and the treatment was safe and well tolerated.

Due to the promising results, Oxford BioMedica has received regulatory approval to use a modified administration procedure that will reduce surgery time and increase the dose.

Parkinson's disease is a degenerative disorder of the central nervous system characterised by muscle rigidity, tremor and a slowing of physical movement, and in extreme cases, a loss of physical movement. The primary symptoms are the result of altered signalling in the area of the brain which is responsible for the control of movement.
The new data was presented at the ‘9th Annual Congress of the French Society of Cell and Gene Therapy’ in Paris by the principal Investigator - Professor Stéphane Palfi, of the Henri Mondor Hospital in Paris. "We are particularly satisfied by the long term safety profile of ProSavin together with the sustained effects in patients”, Professor Stéphane Palfi commented. “This strongly encourages us to go forward in the dose escalation phase with the new method of administration."

The data revealed that 2 out of 3 patients, in the initial low dose group, showed sustained 30% improvement in motor function at two years, and all 3 patients showed an improvement in indicators of clinical benefit. 

“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”, Oxford BioMedica stated.

Furthermore, the company noted that the patients have either had their L-DOPA therapy stabilised, or reduced by up to 40% following treatment with ProSavin. 

According to Oxford BioMedica, the results are in line with what they would have expected to see if ProSavin was establishing a new ‘dopamine factory’ in the patients' brain. Also the company said that the data further supports: ProSavin having long-term benefit in the clinical setting; treating the primary symptoms of Parkinson's disease; and reducing the severe side effects of long term L-DOPA therapy.

“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.”

In reference to the treatments new administration procedure, the company noted that it requires fewer needle tracks and, based on pre-clinical experiments, it may enhance the efficacy of ProSavin. Importantly, with reduced surgery time, Oxford BioMedica said the new method could accelerate ProSavin’s overall development and expand the market opportunity.

“We continue our negotiations around ProSavin with prospective partners from a strengthened position”, Dawson concluded.    

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