Last checked at 3 May 2011 07:00
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
-- Full six-month data set from third cohort to be presented at the American Society of Gene & Cell Therapy 14th Annual Meeting --
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 | 2x | 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-
For further information, please contact: | |
Oxford BioMedica plc: Lara Mott, Head of Corporate Communications |
Tel: +44 (0)1865 783 000 |
Media/Financial Enquiries: Katja Toon/Emma Thompson/Amber Bielecka M:Communications |
Tel: +44 (0)20 7920 2342
|
Notes to editors
1. Oxford BioMedica®
Oxford BioMedica plc (LSE: OXB) is a biopharmaceutical company developing innovative gene-based medicines and therapeutic vaccines that aim to improve the lives of patients with high unmet medical needs. The Company's technology platform includes a highly efficient LentiVector® gene delivery system, which has specific advantages for targeting diseases of the central nervous system and the eye; and a unique tumour antigen (5T4), which is an ideal target for anti-cancer therapy. Through in-house and collaborative research, Oxford BioMedica has a broad pipeline and its partners include sanofi-aventis, Sigma-Aldrich and Pfizer. Further information is available at www.oxfordbiomedica.co.uk.
2. LentiVector® gene delivery technology
Oxford BioMedica's LentiVector® gene delivery technology is one of the most advanced gene delivery systems currently available, which has many applications in product development and discovery research. It is the system of choice for gene-based treatments addressing chronic and inherited diseases. Oxford BioMedica has established a dominant intellectual property estate in the field of lentiviral-vector mediated gene delivery through its in-house research and from work conducted by the Company's co-founders at Oxford University.
3. ProSavin®
ProSavin® uses the Company's LentiVector® gene delivery technology to deliver the genes for three enzymes - AADC (aromatic amino acid decarboxylase), TH (tyrosine hydroxylase) and CH1 (GTP-cyclohydrolase 1) - that are required for the synthesis of dopamine. These genes re-programme transduced cells to manufacture and secrete dopamine. The product is administered locally to the region of the brain called the striatum, converting cells into a replacement dopamine factory within the brain, thus replacing the patient's own lost source of the neurotransmitter. ProSavin® has the potential to address an unmet medical need in Parkinson's disease, offering long-lasting benefit from a single administration with an excellent safety profile.
4. Parkinson's disease
Parkinson's disease affects approximately 1.5 million patients in the seven major markets (US, Japan, UK, France, Germany, Italy and Spain) which is projected to rise to 1.7 million by 2019. None of the current treatments provide long-term relief from symptoms, yet, by 2019, sales of these treatments could exceed US$2.8 billion in the seven major markets (source: Datamonitor, Dec-2010). ProSavin® has the potential to address a major unmet medical need in Parkinson's disease, offering long-lasting benefit from a single administration with an excellent safety profile. The product could therefore also significantly reduce the social care burden that is associated with the mid to late-stage of disease.