SOURCE: Oxford Biomedica Plc

August 01, 2005 02:01 ET

Oxford Biomedica Plc announces Completion of Clinical Trial

OXFORD, UK -- (MARKET WIRE) -- August 1, 2005 --

FOR IMMEDIATE RELEASE                                      1 AUGUST 2005

Oxford, UK: 1 August 2005 - Oxford BioMedica (LSE: OXB), the leading gene therapy company, announced today that the first stage of its Phase II trial in pancreatic cancer with MetXia, the Company's gene targeted prodrug activation product, has been successfully completed. The objectives were to assess the safety of administering MetXia locally to the pancreatic tumour, to confirm gene transfer at the tumour site following local delivery and to identify an optimal dose for the second stage of the trial.

The two-stage Phase II trial is designed to evaluate MetXia and the chemotherapy prodrug cyclosphosphamide (CPA) in patients undergoing palliative surgery for pancreatic cancer. The trial is being conducted at the Royal Liverpool University Hospital. In the first stage of the trial, two dose levels of MetXia were assessed in six patients in combination with a low dose of CPA. Each patient 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 P450 gene, delivered by MetXia, was observed in tumour biopsies taken at surgery.

MetXia comprises a highly engineered retrovirus that delivers the P450 gene to tumour cells. The enzyme encoded by the P450 gene activates CPA to a form that destroys cells. With conventional oral and intravenous administration of CPA, the drug is activated in the liver by the P450 enzyme. This trial utilises catheter-enabled local delivery of both MetXia and CPA to the pancreas, thereby focusing gene delivery and activation of CPA in the target tissue. This minimises the side effects of liver toxicity and systemic dispersal of activated CPA that are associated with oral administration of CPA. The route of administration represents a novel and potentially highly potent strategy for optimising chemotherapy at the tumour site.

Following the encouraging results in stage one of the trial, patient recruitment is commencing for the second stage with a fixed dose of MetXia and increasing doses of CPA. Stage two will accrue up to 25 patients and will determine the optimal dose of CPA. This second stage of the trial is designed to evaluate clinical benefit as well as safety. An additional clinical trial site in London is 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, Professor Alan Kingsman said: "It is very encouraging that MetXia has achieved its endpoints of safety and gene transfer with this novel route of delivery. We look forward to evaluating clinical benefit in the next stage of the trial. There is a clear unmet need for effective therapies for pancreatic cancer, which MetXia has the potential to address. "


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 5000
Buchanan Communications

Scientific/Trade Press Enquiries:
Sue Charles/ Katja Stout/ Ashley Lilly          Tel: +44 (0)20 7886 8150
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 the areas of 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 an immunotherapy and a gene therapy in multiple Phase II trials, and a preclinical targeted antibody therapy in collaboration with Wyeth. In neurotherapy, the Company's lead product is a gene therapy for Parkinson's disease, which is expected to enter clinical trials in 2006, and four further preclinical 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 in Oxford 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 companies including Merck & Co, Biogen Idec and Pfizer.

Further information is available at

2. MetXia® and Pancreatic Cancer

MetXia is Oxford BioMedica's lead gene-based cancer therapeutic. The product comprises a highly engineered retrovirus that delivers a specific human cytochrome P450 gene to tumour cells. The enzyme encoded by the P450 gene activates the commonly used cancer chemotherapy drug, cyclophosphamide (CPA), to a 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 their metastases, particularly those where cyclophosphamide has proven efficacy.

The initial indication for the development of MetXia is the treatment of pancreatic cancer through direct administration of both MetXia and CPA to the tumour. Published data from trials with locally administered CPA and encapsulated cells carrying the P450 enzyme have validated the concept of treating pancreatic cancer with this approach. MetXia uses Oxford BioMedica's gene therapy technology to deliver the P450 gene efficiently to pancreatic tumour cells.

Pancreatic cancer is the fifth leading cause of cancer-related mortality in the United 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, unresectable tumours. Since cancer of the pancreas has the shortest median survival time of all cancer types, there is a critical unmet need for novel, safe and effective treatments.

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