18th Oct 2005 11:30
Oxford Biomedica PLC18 October 2005 FOR IMMEDIATE RELEASE 18 OCTOBER 2005 OXFORD BIOMEDICA ANNOUNCES PRESENTATION BY CLINICIAN OF PHASE II RESULTS WITH METXIA(R) IN PANCREATIC CANCER Oxford, UK: 18 October 2005 - Oxford BioMedica (LSE: OXB), the leading genetherapy company, announced today that a clinician at the Royal LiverpoolUniversity Hospital, UK, presented further data from the first stage of thePhase II trial of MetXia in pancreatic cancer at the 13th United EuropeanGastroenterology Week in Copenhagen, Denmark, on Tuesday, 18 October 2005. The presentation was made by Dr Paula Ghaneh, a consultant surgeon at the RoyalLiverpool University Hospital, specialising in upper gastrointestinal and liversurgery. Dr Ghaneh is one of the principal clinicians for the ongoing trial withMetXia. The presentation assessed and compared clinical data from trials withseveral gene-based therapies in pancreatic and gastrointestinal cancers. DrGhaneh concluded that in contrast with these studies, MetXia therapysuccessfully demonstrated gene transfer in the tumour by regional delivery. The two-stage Phase II trial is designed to evaluate MetXia and the chemotherapyprodrug cyclosphosphamide (CPA) in patients undergoing palliative surgery forpancreatic cancer. In the first stage of the trial, two dose levels of MetXiawere assessed in six patients in combination with a low dose of CPA. Thesepatients all had late stage localised or metastatic disease. Each patient hadtwo administrations of MetXia, prior and subsequent to surgery, followed by CPA. In August, the Company reported that the first stage of the trial had beensuccessfully completed. Both dose levels of MetXia were safe and well tolerated. MetXia comprises a highly engineered retrovirus that delivers the P450 gene totumour cells. The enzyme encoded by the P450 gene activates CPA to a form thatdestroys cells. With conventional oral and intravenous administration of CPA,the drug is activated in the liver by the P450 enzyme. This trial utilisescatheter-enabled local delivery of both MetXia and CPA to the pancreas, therebyfocusing gene delivery and activation of CPA in the target tissue. Thisminimises the side effects of liver toxicity and systemic dispersal of activatedCPA that are associated with oral administration of CPA. The route ofadministration represents a novel and potentially highly potent strategy foroptimising chemotherapy at the tumour site. Following the encouraging results in stage one of the trial, patient recruitmentis ongoing for the second stage with a fixed dose of MetXia and increasing dosesof CPA. Stage two will accrue up to 25 patients and will determine the optimaldose of CPA. The trial is being conducted at the Royal Liverpool UniversityHospital and also at the Hammersmith Hospital, UK. The second stage of the trialis designed to evaluate clinical benefit as well as safety. Preliminary efficacydata from the second stage is expected in early 2006. The 13th United European Gastroenterology Week in Copenhagen, Denmark, on 15-19October 2005 brings together the 15 professional Societies either as Founding orAssociate members. The scope of these Societies ranges from generalgastroenterological medicine and/or surgery to focused organ-oriented andspecial interest associations. The presentation of the MetXia data by Dr Ghanehwas given during a session titled "'Pancreatic Cancer from Gene to Therapy" onTuesday, 18 October 2005. The presentation can be accessed on line atwww.oxfordbiomedica.co.uk from 21 October 2005. The title of the presentation is"Phase II Trials in Gene and Antibody Therapy". Dr Ghaneh of the Royal Liverpool University Hospital said: "We are veryencouraged that MetXia has been well tolerated by patients to date and that wefind expression of the transgene in the tumour. We look forward to recruitingmore patients and evaluating the results from the second stage of the trial". Commenting on the presentation by Dr Ghaneh, Oxford BioMedica's Chief Executive,Professor Alan Kingsman said: "Dr Ghaneh's comparison of MetXia with other genebased therapies addresses the essence of Oxford BioMedica's core capabilities.We established the Company because we believed that we had gene deliverytechnology, the efficiency and safety of which would solve many of the problemsof gene therapy. Her conclusions vindicate that belief. We look forward to theanalysis of the next stage of the trial and hope that we can provide benefit topatients with this devastating disease". -Ends- For further information, please contact: Oxford BioMedica plc:Professor Alan Kingsman, Chief Executive Tel: +44 (0)1865 783 000 City/Financial Enquiries:Lisa Baderoon/ Mark Court/ Mary-Jane Johnson Buchanan Tel: +44 (0)20 7466 5000Communications Scientific/Trade Press Enquiries:Sue Charles/ Katja Stout/ Ashley Lilly Tel: +44 (0)20 7886 8150Northbank 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 the areas ofoncology and neurotherapy. The Company was established in 1995 as a spin outfrom Oxford University, 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 an immunotherapy and a gene therapy in multiple Phase II trials, and apreclinical targeted antibody therapy in collaboration with Wyeth. Inneurotherapy, the Company's lead product is a gene therapy for Parkinson'sdisease, which is expected to enter clinical trials in 2006, and four furtherpreclinical candidates. 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 65 split between its main facilities inOxford and its wholly owned subsidiary, BioMedica Inc, in San Diego, California.Oxford BioMedica has corporate collaborations with Wyeth, Intervet, Viragen,MolMed and Kiadis; and has licensed technology to a number of companiesincluding Merck & Co, Biogen Idec and Pfizer. Further information is available at http://www.oxfordbiomedica.co.uk 2. MetXia(R) and Pancreatic Cancer MetXia is Oxford BioMedica's lead gene-based cancer therapeutic. The productcomprises a highly engineered retrovirus that delivers a specific humancytochrome P450 gene to tumour cells. The enzyme encoded by the P450 geneactivates the commonly used cancer chemotherapy drug, cyclophosphamide (CPA), toa form that destroys cells. MetXia converts the tumour into a 'drug factory',enabling local production of the anti-tumour, cytotoxic derivative of CPA.MetXia is potentially useful in the treatment of all solid tumours and theirmetastases, particularly those where cyclophosphamide has proven efficacy. The initial indication for the development of MetXia is the treatment ofpancreatic cancer through direct administration of both MetXia and CPA to thetumour. Published data from trials with locally administered CPA andencapsulated cells carrying the P450 enzyme have validated the concept oftreating pancreatic cancer with this approach. MetXia uses Oxford BioMedica'sgene therapy technology to deliver the P450 gene efficiently to pancreatictumour cells. Pancreatic cancer is the fifth leading cause of cancer-related mortality in theUnited States with over 30,000 deaths attributable to this disease annually.Survival time is generally less than one year. Treatment options are limited,although chemotherapy is the mainstay for locally advanced, unresectabletumours. Since cancer of the pancreas has the shortest median survival time ofall cancer types, there is a critical unmet need for novel, safe and effectivetreatments. This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
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