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Oxford BioMedica PLC (OXB.L) Announces Publication of Trovax(R) Phase III Analyses In Cancer Immunology, Immunotherapy


3/15/2011 9:19:34 AM

Oxford, UK – 15 March 2011: Oxford BioMedica plc (“Oxford BioMedica” or “the Company”) (LSE: OXB), a leading gene therapy company, today announces that further analyses of the TroVax® Renal Immunotherapy Survival Trial (“TRIST”), a randomised, double-blind, placebo-controlled Phase III study, have been accepted for publication in Cancer Immunology, Immunotherapy, the official journal of the Association for Cancer Immunotherapy.

The online publication of the article, entitled “MVA–5T4-induced immune responses are an early marker of efficacy in renal cancer patients”, can be accessed at: www.springerlink.com/content/b54126121tm63152. TroVax® (MVA-5T4) is a therapeutic cancer vaccine designed to stimulate the immune system to destroy cancerous cells expressing the 5T4 tumour antigen which is broadly distributed throughout a wide range of solid tumours.

The Phase III TRIST results, published in Clinical Cancer Research in November 2010, confirmed the association between a high 5T4 antibody response and enhanced survival in patients treated with TroVax®. Using data from the TRIST study, Oxford BioMedica identified an algorithm (the “Immune Response Surrogate”; IRS) for predicting the quantitative 5T4 antibody response induced by TroVax® in order to identify those patients who are most likely to mount a strong 5T4 antibody response before receiving TroVax®. The IRS is a combination of three baseline (pre-treatment) blood parameters which can be measured using a blood test; 5T4 antibody levels, haemoglobin and haematocrit (the proportion of blood volume occupied by red blood cells).

When applied to the TRIST results, the IRS showed a significant correlation between the 5T4 antibody response, induced following vaccination with TroVax®, and treatment benefit, i.e. patients with higher IRS values who were treated with TroVax® survived longer than patients in the placebo group with the same IRS values. Importantly, the IRS was also associated with 5T4 antibody response and survival when applied to an independent dataset derived from the nine historic Phase I and II studies of TroVax® in patients with renal, colorectal and prostate cancer, implying that the IRS could potentially be applied to multiple cancer types.

The IRS will be used in all future TroVax® clinical trials including the current Phase II study in hormone refractory prostate cancer, in addition to the planned sponsored Phase II studies in mesothelioma, colorectal and ovarian cancers expected to start in 2011. Based on the typical blood profiles of patients with these cancer indications, it is expected that the IRS will predict that the majority of these patient populations may benefit from TroVax®.

Stuart Naylor, Chief Scientific Officer of Oxford BioMedica, said: “Few immunotherapy treatments have demonstrated a direct link between the predicted mode of action and clinical benefit. TroVax® stands apart as a cancer vaccine that elicits a strong and readily definable immune response. The IRS will allow us to target a more responsive patient population and we are confident that this novel biomarker will be further validated by results from our current Phase II clinical development programme for TroVax®."

For further information, please contact:

Oxford BioMedica plc: Lara Mott, Head of Corporate Communications Tel: +44 (0)1865 783 000

Media Enquiries:

Emma Thompson/Amber Bielecka/Katja Toon M:Communications Tel: +44 (0)20 7920 2342

1. Oxford BioMedica®

Oxford BioMedica plc (LSE: OXB) is a biopharmaceutical company developing innovative gene-based medicines and therapeutic vaccines that aim to improve the lives of patients with high unmet medical needs. The Company’s technology platform includes a highly efficient LentiVector® gene delivery system, which has specific advantages for targeting diseases of the central nervous system and the eye; and a unique tumour antigen (5T4), which is an ideal target for anti-cancer therapy. Through in-house and collaborative research, Oxford BioMedica has a broad pipeline and its partners include sanofi-aventis, Sigma-Aldrich and Pfizer. Further information is available at www.oxfordbiomedica.co.uk.

2. TroVax®

TroVax® is Oxford BioMedica’s therapeutic cancer vaccine which is designed 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 Modified Vaccinia Ankara vector, 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 antigen.

3. Cancer Immunology, Immunotherapy

Cancer Immunology, Immunotherapy keeps readers informed of the latest research results in the fields of oncology and immunology. The scope of the journal has broadened to include more of the progress being made in the areas of biology concerned with biological response modifiers which keeps readers up to date on the latest advances in the understanding of tumour-host interactions. The journal publishes short editorials including "position papers," general reviews, original articles, and short communications, providing a forum for the most current experimental and clinical advances in tumour immunology. Cancer Immunology, Immunotherapy is the official journal of the Association for Cancer Immunotherapy.



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