Prosavin preclinical data

Oxford Biomedica PLC 13 November 2006 For Immediate Release 13 NOVEMBER 2006 OXFORD BIOMEDICA PRESENTS ENCOURAGING PRECLINICAL EFFICACY DATA WITH PROSAVIN(R) IN PARKINSON'S DISEASE - Presentation at the 14th Annual Congress of the European Society of Gene Therapy, 9-12 November 2006, in Athens, Greece - Oxford, UK - 13 November 2006: Oxford BioMedica (LSE: OXB), a leading gene therapy company, announced today that new preclinical efficacy results with its gene-based product for Parkinson's disease, ProSavin, were presented at the 14th Annual Congress of the European Society of Gene Therapy (ESGT) in Athens, Greece, which was held on 9-12 November 2006 (http://www.esgt.org). The data showed, for the first time, that ProSavin outperformed the standard treatment for Parkinson's disease, L-DOPA, in terms of efficacy without inducing any of the disabling dyskinesias (movement disorders) that occur following prolonged treatment with L-DOPA. Also, long-term data showed that ProSavin's therapeutic benefit was maintained for at least 15 months, the most recent time point, without any loss of effect. ProSavin is administered locally to the region of the brain called the striatum, delivering the genes for three enzymes that are required for the synthesis of dopamine. These genes are able to reprogram the cells that they enter, enabling these cells to manufacture and secrete dopamine. The treated brain region becomes a new endogenous source of dopamine, replacing the patient's own lost source of the neurotransmitter. Sustained expression of the genes is a key requirement for the product to be clinically successful. Dr Palfi, Head of Neurosurgery at Henri Mondor Hospital, Creteil is the principal researcher conducting the preclinical in vivo evaluation of ProSavin. At the ESGT meeting, Dr Palfi presented a comparison of ProSavin with L-DOPA in an industry standard model of Parkinson's disease. In the early stages of treatment, ProSavin gave high levels of efficacy when evaluated by a series of clinically relevant parameters. In addition, the benefit of a single administration of ProSavin was maintained after a prolonged period, whereas the benefit of continuous L-DOPA therapy waned significantly. Dr. Palfi reported that ProSavin has been effective to the most recent time point of 15 months. The higher efficacy of ProSavin combined with the absence of side effects suggest that ProSavin could be used to replace current standard therapy with L-DOPA in late-stage Parkinson's disease. These new data add to the extensive preclinical data package that supports advancement of the product into human trials. Oxford BioMedica is planning to start a European Phase I/II trial of ProSavin in 2007 in patients with late-stage Parkinson's disease and has proposed a clinical plan to progress to a Phase III trial following success in the Phase I/II trial. The Phase III trial, which is designed to support product registration, could commence in 2009. Discussions with relevant regulatory agencies are ongoing. Commenting on the ProSavin data, Oxford BioMedica's CEO, Professor Alan Kingsman , said: 'These new results substantially strengthen the already impressive preclinical data set for ProSavin and confirm its potential as a treatment for Parkinson's disease, particularly when other therapies fail. Its duration of action and lack of side effects are particularly promising. We are now working towards the start of human trials and have been encouraged by discussions with the regulatory agencies.' -Ends- For further information, please contact: Oxford BioMedica plc: Tel: +44 (0)1865 783 000 Professor Alan Kingsman, Chief Executive City/Financial Enquiries: Tel: +44 (0)20 7466 5000 Lisa Baderoon/ Mark Court/ Mary-Jane Johnson Buchanan Communications Scientific/Trade Press Enquiries: Tel: +44 (0)20 3008 7555 Gemma Bradley/ Susan Yu/ Katja Stout Northbank Communications Notes to editors 1. Oxford BioMedica Oxford BioMedica (LSE: OXB) is a biopharmaceutical company specialising in the development of novel gene-based therapeutics with a focus on oncology and neurotherapy. The Company was established in 1995 as a spin out from Oxford University, and is listed on the London Stock Exchange. Oxford BioMedica has core expertise in gene delivery, as well as in-house clinical, regulatory and manufacturing know-how. In oncology, the pipeline includes two clinical candidates and a preclinical targeted antibody therapy, which is being developed in collaboration with Wyeth. The Company has started Phase III development of its lead cancer immunotherapy product, TroVax, in renal cancer and multiple Phase II trials in various cancer settings are ongoing or planned. In neurotherapy, the Company's lead product, ProSavin, is expected to enter clinical trials in Parkinson's disease in 2007. The preclinical pipeline includes gene-based products for vision loss, motor neuron disease and nerve repair. The Company is underpinned by over 80 patent families, which represent one of the broadest patent estates in the field. The Company has a staff of approximately 70 split between its main facilities in Oxford and its wholly owned subsidiary, BioMedica Inc, in San Diego, California. Oxford BioMedica has corporate collaborations with Wyeth, Intervet, Sigma-Aldrich, Viragen, MolMed, Virxsys and Kiadis; and has licensed technology to a number of companies including Merck & Co, Biogen Idec and Pfizer. Further information is available at www.oxfordbiomedica.co.uk 2. ProSavin(R) ProSavin is Oxford BioMedica's lead neurobiology candidate product for the treatment of Parkinson's disease. ProSavin uses a LentiVector(R) system to deliver the genes for three enzymes that are required for the synthesis of dopamine. The three genes are AADC (aromatic amino acid dopa decarboxylase), TH (tyrosine hydroxylase) and CH1 (GTP-cyclohydrolase 1). The product is administered locally to the striatum, where these genes are able to reprogram transduced cells to manufacture and secrete dopamine. Gene expression is sustained over several months, a key requirement for the product to be clinically successful. This new endogenous source of the neurotransmitter replaces the patient's own lost source of dopamine. The Company had demonstrated preclinical efficacy with ProSavin in an industry standard in vivo model of Parkinson's disease. The preclinical studies suggest that a single treatment with ProSavin has a therapeutic effect after two weeks, and restores almost normal movement after five to eight weeks, which is then maintained. This effect is seldom achieved in this model according to the literature. The clinical manufacturing process has been finalised and the Company has commenced regulatory consultation for the start of clinical trials of ProSavin. 3. Parkinson's Disease Parkinson's disease affects 1% of people over 50 and about 10% of the over 60s. It is a progressive disease caused by the loss of dopamine-producing neurons in a region of the brain called the substantia nigra. Dopamine is required for coordination of movement, and the symptoms of the disease include tremor (shaking), slowness of movement, rigidity (stiffness), and difficulty with balance. Patients with Parkinson's often require care over a period of 10-15 years. The current worldwide market for Parkinson's disease products is about US$2 billion. None of the currently available products provide long-term relief from symptoms. This information is provided by RNS The company news service from the London Stock Exchange END MSCQBLFFQFBBFBE
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