Press releases

Oxford BioMedica Announces Top-Line Results From Six Month Follow-Up of Third Patient Cohort in Prosavin® Phase I/II Study in Parkinson’s Disease

 

Oxford, UK – 3 May 2011: Oxford BioMedica plc (“Oxford BioMedica” or “the Company”) (LSE: OXB), a leading gene therapy company, announces that new data from the on-going Phase I/II trial of ProSavin® for the treatment of Parkinson’s disease (PD) will be presented on Saturday 21 May, 2011 at the American Society of Gene & Cell Therapy (ASGCT) 14th Annual Meeting in Seattle, USA by the study’s Principal Investigator, Professor Stéphane Palfi of the Henri Mondor Hospital in Paris. 

The third patient cohort consists of three patients treated with a 2x dose of ProSavin®using an enhanced administration method.  The top-line results at six months, which have been independently validated, are:

  • Average motor function1 improvement of 43%, with a maximum of 61% in one patient
  • Continued favourable safety profile with no serious adverse events related to ProSavin® or the enhanced administration procedure developed by the Company

1. Motor function is assessed according to the Unified Parkinson’s Disease Rating Scale (UPDRS) in patients’ “OFF” state (i.e. after withdrawal of PD medication).

Summary of improvements in motor function to date2:

Cohort Dose Administration
method
3 months
(UPDRS)
6 months
(UPDRS)
1 year
(UPDRS)
2 years
(UPDRS)
1, n=3 1x Original Mean 27%
Max, up to 30%  
Mean 30%
Max, up to 48%
Mean 29%
Max, up to 44%
Mean 20%
Max, up to 30%
2, n=3 2x Original Mean 28%
Max, up to 53%
Mean 34%
Max, up to 53%
Mean 29%
Max, up to 56%
-
3, n=3 3x Enhanced Mean 26%
Max, up to 52%
Mean 43%
Max, up to 61%
- -

2. Historical data has been independently verified.

John Dawson, Chief Executive Officer of Oxford BioMedica, said: “With an average motor function improvement of 43%, these are the highest efficacy results we have reported for our ProSavin® Phase I/II programme to date.  Subject to advice from the study’s Data Monitoring Committee and regulatory bodies, we believe the current data set already supports advancing ProSavin® into sham-controlled studies at the earliest opportunity.  If these results are confirmed in randomised studies, ProSavin® has the potential to significantly improve the treatment paradigm for Parkinson’s disease patients globally.  We look forward to the presentation of the full data set at the ASGCT and, with results from the higher 5x dose cohort expected in H2 2011, remain confident that the strength of these data will help to derive maximum value from our partnering discussions.”

-Ends-

Notes to editors

About Oxford BioMedica®

Oxford BioMedica (LSE:OXB) is a leading gene and cell therapy company focused on developing life changing treatments for serious diseases. Oxford BioMedica and its subsidiaries (the “Group”) have built a sector leading lentiviral vector delivery platform (LentiVector®) through which the Group develops in vivo and ex-vivo products both in-house and with partners. The Group has created a valuable proprietary portfolio of gene and cell therapy product candidates in the areas of oncology, ophthalmology and CNS disorders. The Group has also entered into a number of partnerships, including with Novartis, Sanofi, GSK, and Immune Design, through which it has long-term economic interests in other potential gene and cell therapy products. Oxford BioMedica is based across several locations in Oxfordshire, UK and employs more than 250 people. Further information is available at www.oxfordbiomedica.co.uk.

For further information please contact

Oxford BioMedica plc

John Dawson, Chief Executive Officer

Tim Watts, Chief Financial Officer

Tel: +44 (0)1865 783 000

 

Consilium Strategic Communications – Media Enquiries

Mary-Jane Elliott/Matthew Neal/Philippa Gardner/Laura Thornton

Tel: +44 (0)20 3709 5700

 

Jefferies (Corporate Broker) 

Gil Bar-Nahum/Simon Hardy/Lee Morton/Max Jones/Nicholas Moore

Tel: +44 (0)20 7029 8000