Oxford, UK: 16 November 2005 – Oxford BioMedica (LSE: OXB), a gene therapy company, announced today that the first patient has been treated in a second Phase II trial with TroVax in combination with interleukin-2 (IL-2) in patients with metastatic renal cell carcinoma (RCC). There are now five Phase II trials ongoing with TroVax in RCC and colorectal cancer.

The first patient was treated in a second Phase II trial in RCC at the Methodist Hospital in Texas, US, on 14 November 2005. This open label trial is expected to recruit up to 25 patients. The Principal Investigator for the trial is Dr Robert Amato, who is an internationally recognised opinion leader in the treatment of RCC. The trial is designed to evaluate the safety and immunogenicity of TroVax in conjunction with low dose IL-2, which is commonly used in the treatment of RCC. Initial data from this trial are expected in the first half of 2006.

The Company is targeting RCC as a lead indication for the development of TroVax, in addition to colorectal cancer. As reported on 2 November 2005, the Company believes that RCC is an indication where TroVax might achieve a rapid route to product registration. The Company aims to initiate a Phase III trial of TroVax in RCC in 2006 and is targeting product registration in 2009. In parallel, the Company is conducting negotiations with potential partners for TroVax. The current treatment market for RCC is approximately US$600 million according to Datamonitor.

Commenting on the news, Oxford BioMedica’s Chief Medical Officer, Dr Mike McDonald, said: “We are delighted to have Dr Amato’s support for the TroVax programme as we also prepare to begin a large randomised Phase III registration trial in mid 2006. The Phase III trial will assess the impact of TroVax in prolonging survival of patients with this rapidly progressive disease.”
 

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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 70 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, Sigma-Aldrich, 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 www.oxfordbiomedica.co.uk

2. TroVax^® cancer immunotherapy

TroVax is Oxford BioMedica’s leading cancer immunotherapy product. It is designed specifically to stimulate an anti-cancer immune response and has potential application in most solid tumour types. TroVax targets the tumour antigen 5T4, which is broadly distributed throughout a wide range of solid tumours. The presence of 5T4 is correlated with poor prognosis. The product consists of a poxvirus (MVA) gene transfer system, which delivers the gene for 5T4 and stimulates a patient’s body to produce an anti-5T4 immune response. This immune response destroys tumour cells carrying the 5T4 protein.

TroVax is currently in five Phase II trials, including an investigator initiated trial sponsored by Cancer Research UK. Over 85 patients have been treated with TroVax (collectively over 350 doses) in five clinical trials in colorectal cancer and renal cell carcinoma. Clinical results have shown that the product is safe and stimulates an anti-tumour immune response against 5T4 in the majority of patients. Data from the completed Phase I/II trial and ongoing Phase II trials suggest that the magnitude of the immune response induced by TroVax correlates with clinical benefit including tumour responses and time to disease progression, both of which have exceeded expectation based on published historical data. A Phase III trial in renal cell carcinoma is planned to start in 2006.

3. Renal Cell Carcinoma

Renal cell carcinoma (RCC) is the most common form of kidney cancer and the tenth most common cancer in the United States. More than 150,000 people are newly diagnosed with RCC worldwide each year. Prognosis is very poor. If RCC has metastasised to other organs at the time of first diagnosis, the five-year survival rate is less than five per cent. In the United States and Europe, RCC accounts for more than 33,000 deaths each year.

There are no approved treatments to date that prolong the survival of metastatic RCC patients. Commonly used treatments for patients with metastatic RCC include cytokines such as interferon-alpha, which has limited efficacy, and interleukin-2, which is associated with side effects. About 40 per cent of patients with RCC develop metastases after surgery.