Oxford Biomedica announces promising interim Phase I/II results of ProSavin in Parkinson's disease

11-Sep-2008 - United Kingdom

Oxford BioMedica announced promising interim results from the Phase I/II trial of its novel gene therapy, ProSavin, for the treatment of Parkinson’s disease. The three patients in the first-dose cohort showed improvements in disease symptoms, as measured by the Unified Parkinson’s Disease Rating Score (UPDRS) in the ‘off’ state, of up to 30% at three months. An independent Data Monitoring Committee (DMC) has reviewed the data, as required by the study protocol, and recommended that the trial continues to evaluate the higher dose of ProSavin.

There were no serious adverse events associated with the surgical procedure for administration of ProSavin into the brain. All three patients were ambulatory within 48 hours of the procedure. At three months post ProSavin administration, patients showed an improvement of 23-30% as measured by the UPDRS ‘off’ score. This measures the degree of mobility in the absence of standard of care dopaminergic therapies. Two patients showed improvements in Quality of Life measures (QoL) that are specific to patients with Parkinson’s disease, and one patient’s QoL was unchanged. The primary efficacy endpoint of the study is based on the UPDRS Part III (motor score) assessment at six months after treatment.

The independent DMC has reviewed the three-month data and recommended that the trial advances to the evaluation of the higher dose of ProSavin. The first patient of this second cohort is expected to be treated in September 2008. Assuming the trial progresses as planned, the Company anticipates preliminary data from patients at the higher dose and the start of the second stage of the trial in the first quarter of 2009.

https://www.bionity.com/en/news/86958/oxford-biomedica-announces-promising-interim-phase-i-ii-results-of-prosavin-in-parkinson-s-disease.html