1st Aug 2005 07:00
Oxford Biomedica PLC01 August 2005 FOR IMMEDIATE RELEASE 1 AUGUST 2005 OXFORD BIOMEDICA SUCCESSFULLY COMPLETES STAGE ONE OF THE PHASE II TRIAL WITH METXIA(R) IN PANCREATIC CANCER Oxford, UK: 1 August 2005 - Oxford BioMedica (LSE: OXB), the leading genetherapy company, announced today that the first stage of its Phase II trial inpancreatic cancer with MetXia, the Company's gene targeted prodrug activationproduct, has been successfully completed. The objectives were to assess thesafety of administering MetXia locally to the pancreatic tumour, to confirm genetransfer at the tumour site following local delivery and to identify an optimaldose for the second stage of the trial. The two-stage Phase II trial is designed to evaluate MetXia and the chemotherapyprodrug cyclosphosphamide (CPA) in patients undergoing palliative surgery forpancreatic cancer. The trial is being conducted at the Royal LiverpoolUniversity Hospital. In the first stage of the trial, two dose levels of MetXiawere assessed in six patients in combination with a low dose of CPA. Eachpatient had two administrations of MetXia, prior and subsequent to surgery,followed by CPA. Both dose levels of MetXia were safe and well tolerated.Importantly, dose dependent expression of the specific human cytochrome P450gene, delivered by MetXia, was observed in tumour biopsies taken at surgery. 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 commencing for the second stage with a fixed dose of MetXia and increasingdoses of CPA. Stage two will accrue up to 25 patients and will determine theoptimal dose of CPA. This second stage of the trial is designed to evaluateclinical benefit as well as safety. An additional clinical trial site in Londonis expected to open for part two of the trial, which will boost patient accrual.Preliminary efficacy data is expected in early 2006. Commenting on the MetXia results, Oxford BioMedica's Chief Executive, ProfessorAlan Kingsman said: "It is very encouraging that MetXia has achieved itsendpoints of safety and gene transfer with this novel route of delivery. We lookforward to evaluating clinical benefit in the next stage of the trial. There isa clear unmet need for effective therapies for pancreatic cancer, which MetXiahas the potential to address. " -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 Tel: +44 (0)20 7466 5000Buchanan Communications 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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