Oxford Biomedica says study of ProSavin Parkinson’s treatment progressing well

Gene therapy group Oxford Biomedica PLC (AIM: OXB) said the Phase I/II study of its novel gene therapy, ProSavin, for the treatment of Parkinson's disease is progressing well.

Patients treated at the first dose level have maintained their improvement in motor function for one year, with an average improvement of 29 percent. Analogous investigator assessments of patients in the second cohort treated at a higher dose level have achieved similar benefit at three months, and the first patient to reach their six-month assessment has demonstrated further improvement.
The independent data monitoring committee supported Oxford BioMedica's proposal to proceed to a third dose level incorporating the company's new administration technology.

The ongoing Phase I/II study is designed to evaluate the safety and efficacy of ProSavin in patients with mid-stage Parkinson's disease who are experiencing reduced benefit on L-DOPA 'equivalent' therapy.

ProSavin is administered directly into the striatum of the brain using a well established surgical technique. The first stage of the study is a dose escalation in cohorts of three patients at each dose level and, to date, six patients have been treated.

ProSavin has been safe and well tolerated in all patients, with no serious adverse events and no evidence of immunotoxicity. All patients have reduced or maintained their PD medication relative to baseline.

The monitoring committee supports the company's proposal to proceed directly to a third dose level that is five-fold higher than the first dose level. Oxford Biomedica will incorporate its new delivery technology for the administration of the 5x dose level of ProSavin.

The new technique reduces the surgical time, facilitates higher dosing and has the potential to provide better reproducibility as study centres expand and thus accelerate clinical development timelines. A protocol amendment for the new technology is being prepared, which it plans to submit to French healthcare regulatory agency, AFSSAPS, before the end of the third quarter of 2009.