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- Principal Investigator for TroVax Phase II trials to present at Cancer Immunotherapuetics & Vaccines meeting on 22-23 August 2006 - Oxford, UK – 21 August 2006: Oxford BioMedica (LSE: OXB), a leading gene therapy company, announces that Dr. Robert Amato of the Genitourinary Oncology Centre, the Methodist Hospital in Houston, USA, will make a presentation on TroVax at the third annual Cancer Immunotherapeutics & Vaccines meeting in Cambridge, Massachusetts, USA on 22 August 2006 at 14:45 EST (http://www.healthtech.com/2006/cvc/index.ASP). The presentation will include previously reported data from a Phase II trial of TroVax in renal cell carcinoma. Dr Amato will present, in detail, the design of the study and preliminary safety, immunological and efficacy data. Dr Amato is the Principal Investigator for an ongoing Phase II trial of TroVax in renal cell carcinoma (RCC) in approximately 25 patients. The trial is designed to evaluate the safety and immunogenicity of TroVax in conjunction with low dose interleukin-2, which is commonly used in the treatment of RCC. Initial results from this Phase II trial were presented at the American Society of Clinical Oncology meeting in June 2006, confirming that TroVax is safe and well tolerated with early indications of significant tumour responses. Dr. Amato is an internationally recognised opinion leader in the treatment of RCC. He is the Principal Investigator for three of the five ongoing Phase II trials of TroVax in RCC and also the Phase II trial of TroVax in prostate cancer. Oxford BioMedica expects to commence patient recruitment in its Phase III trial in RCC, designated as TRIST (TroVax Renal Immunotherapy Survival Trial), during the second half of 2006. Oxford BioMedica has a Special Protocol Assessment agreement from the US Food and Drug Administration for the TRIST study. Further trials are also planned in colorectal cancer and other cancer types. -Ends-
Notes to editors1. Oxford BioMedica 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 candidates in multiple Phase II trials, and a preclinical targeted antibody therapy in collaboration with Wyeth. A Phase III trial in renal cancer with TroVax, the lead cancer immunotherapy candidate, is expected to start in the second half of 2006. In neurotherapy, the Company’s lead product is a gene therapy for Parkinson’s disease, which is expected to enter clinical development 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, 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. TroVax has attracted external support from Cancer Research UK and the US National Cancer Institute. Over 120 patients have now been treated with TroVax in eight clinical trials (collectively over 450 doses). 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. A clinical trial in prostate cancer is also underway and a trial in breast cancer is planned. 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 5%. In the United States and Europe, RCC accounts for more than 33,000 deaths each year. About 40% of patients with RCC develop metastases after surgery. Analyses of sample tissues from patients with RCC have shown that the 5T4 tumour antigen is present at high levels on approximately 90% of tumours. Hence, RCC is a logical target for a 5T4-targeted immunotherapeutic.
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