ProSavin is an experimental drug believed to be of use in the treatment of Parkinson’s Disease. It is administered to the striatum in the brain, inducing production of dopamine.
It is manufactured by Oxford BioMedica, who started European Phase I clinical trials in 2007. Prior to the test on Parkinson’s patients, animal trials have been a success, with dopamine levels restored without the side effects associated with other current treatments for Parkinson’s, in particular, without the jerky involuntary movements associated with current drugs.
Nine new patients will begin new clinical trials during 2011 and if these trials prove successful this could lead to new treatments for Parkinson’s disease. pkp
Parkinson’s Disease Hope
By Maggie Hartford
GENE therapy company Oxford BioMedica has announced encouraging safety results from the first human trials of its treatment for Parkinson’s Disease, ProSavin.
The company, based at Oxford Science Park, said ProSavin continued to be safe and well-tolerated following treatment with an enhanced technique to reduce surgical delivery time.
So far, nine patients have been treated at the Henri Mondor Hospital, Paris, and showed some imporvement in motor function, with an increase in symptom-free time.
Regulators are supporting the company’s plan to give a higher dose to six patients next year and to open a second test site at Addenbrookes Hospital, Cambridge.
Commenting on the nine patients treated, Prof Stéphane Palfi, at Henri Mondor, said: “The safety of the new administration method and the continued safety profile of ProSavin are both very favourable and the data from the earlier cohorts provide encouraging signs of long-term benefit.
“We can now be confident to administer ProSavin at a dose which showed the best benefit in a severe pre-clinical model of Parkinson’s disease.”
Chief executive John Dawson described the study as “an appropriately cautious approach to a potentially revolutionary treatment for Parkinson’s disease”.
He said: “With the excellent safety profile and sustained, positive signs of clinical benefit we have seen at the lower doses, we are confident that progressing ProSavin to the higher dose could further enhance efficacy and therefore significantly increase the product’s value.
He added: “We are making the necessary preparations to advance ProSavin into Phase II development as rapidly as possible including site expansion, regulatory guidance and manufacturing and we look forward to continuing our discussions with potential partners as we generate more data from this increasingly valuable asset.”