License Agreement

Oxford Biomedica PLC 17 September 2004 FOR IMMEDIATE RELEASE SEPTEMBER 2004 OXFORD BIOMEDICA SIGNS LICENSE AGREEMENT WITH MASSACHUSETTS GENERAL HOSPITAL, BOSTON UNIVERSITY AND DANA-FARBER CANCER INSTITUTE Oxford, UK - 16 September 2004: Oxford BioMedica (LSE: OXB), the cancer and neurobiological gene therapy company, announced today that it has signed an agreement with Massachusetts General Hospital, Boston University and Dana-Farber Cancer Institute extending the field of Oxford BioMedica's exclusive access to the family of cytochrome P450 enzymes in cancer gene therapy. The P450 enzyme is used in Oxford BioMedica's novel cancer gene therapy product, MetXia(R). The extension of the license covers the development of MetXia as a treatment for pancreatic cancer. Under a separate agreement also signed today, Massachusetts General Hospital, Boston University and Dana-Farber Cancer Institute have subscribed for a total of 352,887 ordinary shares of 1p each at 15.78 pence per share. The P450 enzyme is naturally expressed in the liver and activates the chemotherapeutic drug cyclophosphamide. By delivering a specific P450 gene, MetXia promotes activation of cyclophosphamide directly in the tumour and thereby enhances its potency as an anti-tumour treatment. Oxford BioMedica licensed the rights to the P450 enzyme for cancer gene therapy from Massachusetts General Hospital, Boston University and Dana-Farber Cancer Institute in 1997 and extended the agreement previously in 2000. Oxford BioMedica has demonstrated proof of concept with MetXia in two Phase I/II trials in patients with accessible tumours, primarily in breast cancer. In April 2004, the Company reported that recruitment had started in a Phase I trial, rolling into a Phase II trial in patients with pancreatic cancer. The safety stage of this trial is on-track to complete by the end of the year. -Ends- For further information, please contact: Oxford BioMedica plc: ------------------------ Professor Alan Kingsman, Chief Executive Tel: +44 (0)1865 783 000 Nick Woolf, SVP Corporate Strategy City/Financial Enquiries: --------------------------- Lisa Baderoon/ Mark Court/ Mary-Jane Johnson: Buchanan Communications Tel: +44 (0) 7466 5000 Scientific/Trade Press Enquiries: ----------------------------------- Sue Charles, Katja Stout: Northbank Communications Tel: +44 (0)20 7886 8150 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. In addition to its technical expertise in gene delivery, Oxford BioMedica has in-house clinical, regulatory and manufacturing know-how. The development pipeline includes two novel anti-cancer products in clinical trials; two neurotherapy products in advanced preclinical development for Parkinson's disease and retinopathy; and three further preclinical neurotherapy products. The Company is underpinned by an extensive preclinical and research portfolio and about 70 patent families, which represents one of the broadest patent estates in the field. The Company has a staff of approx. 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, Merck & Co, Amersham, Viragen and Kiadis. Further information is available at www.oxfordbiomedica.co.uk. 2. MetXia(R) gene therapy for cancer A common strategy for the treatment of cancer is to administer cytotoxic (or cell killing) drugs in an attempt to destroy the tumour. Cyclophosphamide is one of a group of drugs that is taken by the patient in the form of an inactive prodrug. The prodrug travels through the body to the liver where enzymes convert it to the active, cytotoxic form. This approach affects the whole body and leads to the familiar adverse side effects of cancer chemotherapy because the cytotoxic drug destroys normal cells on its way from the liver to the tumour. In addition, because the activating enzymes are present only in the liver, high doses of prodrug must be given to achieve therapeutic levels of the cytotoxic drug at the tumour site. Often the therapeutic effect is compromised by the toxicity. Oxford BioMedica's MetXia addresses these problems by delivering a specific human cytochrome P450 gene (CYP2B6) directly to the tumour using a highly engineered retrovirus gene delivery system. Once incorporated into the genetic material of the tumour cells, this gene produces the liver enzyme that converts the cyclophosphamide prodrug to its active form within the tumour. The aim is to achieve high concentrations of activated cyclophosphamide locally in the tumour while minimising circulating levels of the drug. This could increase the sensitivity of the tumour to the drug and reduce the dose of cyclophosphamide, thereby reducing adverse side effects. Two Phase I/II trials have been completed in patients with accessible tumours, principally breast cancer. MetXia was safe, well tolerated and there was observable clinical benefit. In addition to local effects on tumour nodules that had been treated with MetXia, there was evidence of induction of systemic anti-tumour immune responses. The current clinical trial of MetXia in pancreatic cancer is a Phase I trial rolling into a Phase II trial. Recruitment commenced in April 2004. This trial is designed for direct administration of the both MetXia and cyclophosphamide to the tumour via arterial infusion. 3. Massachusetts General Hospital Founded in 1811, the Massachusetts General Hospital (MGH) is the third oldest general hospital in the US and the oldest and largest in New England. The 895-bed world-renowned medical centre offers sophisticated diagnostic and therapeutic care in virtually every specialty and subspecialty of medicine and surgery. The MGH conducts the largest hospital-based research programme in the US, with an annual research budget of more than $400 million. It is the oldest and largest teaching hospital of Harvard Medical School, and nearly all of the hospital's active staff physicians are on the Harvard Medical School faculty. MGH is part of Dana-Farber/Partners CancerCare, a collaborative programme for adult oncology that also involves Dana-Farber Cancer Institute and Brigham and Women's Hospital. 4. Dana-Farber Cancer Institute Dana-Farber Cancer Institute is a principal teaching affiliate of the Harvard Medical School and is among the leading cancer research and care centers in the United States. It is a founding member of the Dana-Farber/Harvard Cancer Center (DF/HCC), and is designated as a comprehensive cancer centre by the National Cancer Institute. This information is provided by RNS The company news service from the London Stock Exchange
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