http://www.pharmabiz.com/NewsDetails...id=63074&sid=2

... With patient diary measures further supporting the positive impact on patients’ lives, these data underline the potential for this novel approach to address the motor symptoms of Parkinson’s disease. Our LentiVector platform technology is designed to treat chronic, degenerative diseases and the ProSavin results to date demonstrate the long-term benefits associated with a single administration.”

Tom Isaacs, president and co-founder of The Cure Parkinson’s Trust and person with Parkinson’s disease, said: “ProSavin is one of the more advanced of the prospective gene therapy products in development ... These statistics indicate that, at last, there might be an effective and enduring alternative means of re-asserting control over the movement of your own body. People with Parkinson’s everywhere should take heart.”

The on-going phase I/II study is designed to assess the safety, efficacy and dose evaluation of ProSavin in patients with mid-stage PD who are experiencing reduced benefit on L-DOPA “equivalent” therapy....

Two dose levels (1x and 2x) have been evaluated in nine patients to date. ...

A further higher (5x) dose of ProSavin is being assessed in the current six-patient cohort; the scaled equivalent to the optimal dose in pre-clinical studies. Three-month results from the first three patients in the 5x dose cohort are expected mid-2011 and will be announced in H2 2011 following a review by the study’s independent Data Monitoring Committee (DMC). Planning is on-going for a sham-controlled phase II study that will recruit up to 50 patients. Depending on the results from the 5x dose cohort and the independent opinion from the study’s DMC, a randomised phase II trial of ProSavin could be initiated in the EU/US in 2012.