13th Nov 2006 07:01
Oxford Biomedica PLC13 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 genetherapy company, announced today that new preclinical efficacy results with itsgene-based product for Parkinson's disease, ProSavin, were presented at the 14thAnnual 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 datashowed, for the first time, that ProSavin outperformed the standard treatmentfor Parkinson's disease, L-DOPA, in terms of efficacy without inducing any ofthe disabling dyskinesias (movement disorders) that occur following prolongedtreatment with L-DOPA. Also, long-term data showed that ProSavin's therapeuticbenefit 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 ofdopamine. These genes are able to reprogram the cells that they enter, enablingthese cells to manufacture and secrete dopamine. The treated brain regionbecomes a new endogenous source of dopamine, replacing the patient's own lostsource of the neurotransmitter. Sustained expression of the genes is a keyrequirement for the product to be clinically successful. Dr Palfi, Head of Neurosurgery at Henri Mondor Hospital, Creteil is theprincipal researcher conducting the preclinical in vivo evaluation of ProSavin.At the ESGT meeting, Dr Palfi presented a comparison of ProSavin with L-DOPA inan industry standard model of Parkinson's disease. In the early stages oftreatment, ProSavin gave high levels of efficacy when evaluated by a series ofclinically relevant parameters. In addition, the benefit of a singleadministration of ProSavin was maintained after a prolonged period, whereas thebenefit of continuous L-DOPA therapy waned significantly. Dr. Palfi reportedthat ProSavin has been effective to the most recent time point of 15 months. The higher efficacy of ProSavin combined with the absence of side effectssuggest that ProSavin could be used to replace current standard therapy withL-DOPA in late-stage Parkinson's disease. These new data add to the extensivepreclinical data package that supports advancement of the product into humantrials. Oxford BioMedica is planning to start a European Phase I/II trial of ProSavin in2007 in patients with late-stage Parkinson's disease and has proposed a clinicalplan 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, couldcommence 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 impressivepreclinical data set for ProSavin and confirm its potential as a treatment forParkinson's disease, particularly when other therapies fail. Its duration ofaction and lack of side effects are particularly promising. We are now workingtowards the start of human trials and have been encouraged by discussions withthe regulatory agencies." -Ends- For further information, please contact: Oxford BioMedica plc: Tel: +44 (0)1865 783 000Professor 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 7555Gemma Bradley/ Susan Yu/ Katja StoutNorthbank Communications Notes to editors 1. Oxford BioMedica Oxford BioMedica (LSE: OXB) is a biopharmaceutical company specialising in thedevelopment of novel gene-based therapeutics with a focus on oncology andneurotherapy. The Company was established in 1995 as a spin out from OxfordUniversity, and is listed on the London Stock Exchange. Oxford BioMedica has core expertise in gene delivery, as well as in-houseclinical, regulatory and manufacturing know-how. In oncology, the pipelineincludes two clinical candidates and a preclinical targeted antibody therapy,which is being developed in collaboration with Wyeth. The Company has startedPhase III development of its lead cancer immunotherapy product, TroVax, in renalcancer and multiple Phase II trials in various cancer settings are ongoing orplanned. In neurotherapy, the Company's lead product, ProSavin, is expected toenter clinical trials in Parkinson's disease in 2007. The preclinical pipelineincludes gene-based products for vision loss, motor neuron disease and nerverepair. The Company is underpinned by over 80 patent families, which represent one ofthe broadest patent estates in the field. The Company has a staff ofapproximately 70 split between its main facilities in Oxford and its whollyowned subsidiary, BioMedica Inc, in San Diego, California. Oxford BioMedica hascorporate collaborations with Wyeth, Intervet, Sigma-Aldrich, Viragen, MolMed,Virxsys and Kiadis; and has licensed technology to a number of companiesincluding 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 thetreatment of Parkinson's disease. ProSavin uses a LentiVector(R) system todeliver the genes for three enzymes that are required for the synthesis ofdopamine. The three genes are AADC (aromatic amino acid dopa decarboxylase), TH(tyrosine hydroxylase) and CH1 (GTP-cyclohydrolase 1). The product isadministered locally to the striatum, where these genes are able to reprogramtransduced cells to manufacture and secrete dopamine. Gene expression issustained over several months, a key requirement for the product to beclinically successful. This new endogenous source of the neurotransmitterreplaces the patient's own lost source of dopamine. The Company had demonstrated preclinical efficacy with ProSavin in an industrystandard in vivo model of Parkinson's disease. The preclinical studies suggestthat a single treatment with ProSavin has a therapeutic effect after two weeks,and restores almost normal movement after five to eight weeks, which is thenmaintained. This effect is seldom achieved in this model according to theliterature. The clinical manufacturing process has been finalised and theCompany has commenced regulatory consultation for the start of clinical trialsof 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 ina region of the brain called the substantia nigra. Dopamine is required forcoordination of movement, and the symptoms of the disease include tremor(shaking), slowness of movement, rigidity (stiffness), and difficulty withbalance. Patients with Parkinson's often require care over a period of 10-15years. The current worldwide market for Parkinson's disease products is aboutUS$2 billion. None of the currently available products provide long-term relieffrom symptoms. This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
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