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Oxford Biomedica Reports Further Encouraging Phase Ii Results With Trovax In Renal And Prostate Cancer

10 Nov 2006

Presentations at the 18th EORTC-NCI-AACR Symposium, 7-10 November 2006 in Prague, Czech Republic

OXFORD, UK | Nov 09, 2006 | Oxford BioMedica (LSE: OXB), a leading gene therapy company, announced today that Dr. Robert

Amato has presented further encouraging data from three Phase II trials of TroVax, the Company’s lead cancer immunotherapy product, in renal cell carcinoma and prostate cancer at the 18th EORTC-NCI-AACR Symposium on "Molecular Targets and Cancer Therapeutics", which is being held on 7-10 November 2006 in Prague, Czech Republic. http://www.fecs.be/emc.asp?pageId=973&Type=P

Dr. Amato of the Genitourinary Oncology Centre, the Methodist Hospital in Houston, USA, is the Principal Investigator for two ongoing Phase II trials of TroVax in renal cell carcinoma (RCC) and a Phase II trial of TroVax in prostate cancer.

The RCC trials are designed to evaluate the safety, immunogenicity and effectiveness of TroVax as a single agent and in combination with standard therapy of interleukin-2 (IL-2) or interferon-a (IFN). The regimen comprises seven intramuscular injections of TroVax over 41 weeks. To date, the two trials have enrolled 33 patients with progressive metastatic RCC and 18 patients are currently receiving therapy. All patients were heavily pre-treated before entering the trials. Dr. Amato presented data showing that TroVax was well tolerated and has shown promising anti-tumour activity in this patient group. One patient had a complete response (tumour eradication) and two patients developed a partial response (tumour shrinkage). A further 15 patients showed disease stabilisation for periods exceeding three months, including one patient that has been stable for more than 46 weeks. Overall survival in the two studies is too early to assess and has yet to reach a median. The immunological analysis is ongoing but a preliminary assessment has shown that TroVax induced 5T4-specific antibody responses in more than 90% of evaluable patients. Importantly, in patients with clear cell RCC, there was a statistically significant correlation (p=0.028) between the immune response to 5T4 and clinical benefit based on changes in patients’ tumour burden. This is particularly encouraging since it supports the rationale that the 5T4-specific immune response induced by TroVax has therapeutic benefit. Clear cell RCC is the most common subtype of renal cancer and is the patient group for the Phase III TRIST study.

The Phase II trial in prostate cancer is similarly designed to evaluate the safety and immunogenicity of TroVax as a single agent and in combination with standard therapy of GM-CSF. The regimen comprises ten intramuscular injections of TroVax over 45 weeks. The trial has enrolled 27 patients with hormone-refractory prostate cancer and eight patients continue to receive therapy. TroVax was well tolerated and all patients developed a strong 5T4-specific antibody response whether or not they received GM-CSF. Analysis of cytotoxic T-cell immune responses stimulated by TroVax in the renal and prostate cancer trials is ongoing.

Dr Mike McDonald, Oxford BioMedica’s Chief Medical Officer, commented on the new data: “We are very encouraged by the data emerging form these Phase II trials. The data provide further evidence that TroVax can be administered safely and that it induces consistent antibody responses to the target tumour antigen 5T4. The correlation between immune and clinical responses supports our Phase III development strategy of TroVax in renal cancer”.

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Notes
1. Oxford BioMedica plc

Oxford BioMedica (LSE: OXB) is a biopharmaceutical company specialising in the development of novel gene-based therapeutics with a focus on 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 two clinical candidates and a preclinical targeted antibody therapy, which is being developed in collaboration with Wyeth. The Company has started Phase III development of its lead cancer immunotherapy product, TroVax, in renal cancer and multiple Phase II trials in various cancer settings are ongoing or planned. In neurotherapy, the Company’s lead product, ProSavin, is expected to enter clinical trials in Parkinson’s disease in 2007. The preclinical pipeline includes gene-based products for vision loss, motor neuron disease and nerve repair.

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, Virxsys 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®

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. The Company is targeting colorectal cancer and renal cell carcinoma as lead indications for the development of TroVax. Renal cell carcinoma is an indication where TroVax might achieve a rapid route to product registration. Oxford BioMedica has started a Phase III trial (TRIST – TroVax Renal Immunotherapy Survival Trial) in 700 patients with advanced renal cell carcinoma. The TRIST study received a Special Protocol Assessment from the US Food and Drug Administration in May 2006. A Phase II trial in prostate cancer is ongoing and a trial in breast cancer is due to start under the auspices of the US Southwest Oncology Group. To date, over 150 patients with colorectal, renal or prostate cancer (collectively over 500 doses) have been treated with TroVax. The product has attracted support from Cancer Research UK, the US National Cancer Institute, and the UK clinical trials network, QUASAR. These organisations are already conducting or plan to conduct clinical trials with TroVax.

SOURCE: Oxford BioMedica

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