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November 17, 2004

Onyvax Discovers Clinical Responses To Prostate Cancer Vaccine Correlate With Immunological Data Analysis

London, UK, 18 November 2004: Onyvax Limited, the biotechnology company developing novel cancer therapies, today announced at the American Association of Cancer Research meeting focussed on ‘Basic, Translational and Clinical Advances In Prostate Cancer’, that it has discovered a signature immunological profile which can potentially predict the clinical responses seen in its Onyvax-P Phase II clinical trial in prostate cancer patients.

The search for immunological markers that are clearly linked to clinical events in cancer vaccine trials has proven to be one of the key challenges facing researchers. The traditional approach of comparing data ‘snapshots’ before and after treatment or following a single parameter over time has yielded few insights and no reliable markers. As a result, the analysis of many cancer vaccine trials has been difficult. Onyvax scientists, in collaboration with Dr Graham Balls, BioInformatician at Loreus Ltd and the School of Biomedical and Natural Sciences at Nottingham Trent University (UK), reasoned that standard, linear data analysis would be inadequate to model the complexity of the diverse immune responses in patients receiving Onyvax-P vaccine therapy.

Instead, the data were subjected to non-linear statistical analysis and advanced pattern recognition using an Artificial Neural Network (ANN) approach. Blood samples taken throughout the clinical trial were subjected to a battery of immunological assays, including cell surface marker expression, T-cell proliferation and cytokine analysis. The ANN was constructed using a custom set of algorithms designed by the Nottingham group and a model was developed capable of determining clinical responders and non-responders. Sensitivity analysis revealed that the most predictive measurements were interferon gamma (IFN-gamma), tumour necrosis factor alpha (TNF-alpha) and interleukin 2 (IL-2), three immune factors indicative tumour killing through cellular immune activity.

Dr Mike Whelan, Head of Research at Onyvax, said: “There is a clear unmet need for surrogate markers of clinical efficacy that can be used to determine the outcome of novel therapies. Sophisticated techniques such as ANN are required when analysing patients’ immunological responses to Cell Vaccines which contain hundreds of tumour antigens. This work will prove invaluable for future trials of Onyvax-P and other Cell Vaccines in the company’s pipeline.”

Onyvax is planning to conduct final stage clinical trials of Onyvax-P in advanced prostate cancer patients in 2005.

For further information, please contact:

Dr Anthony Walker / Robert Johnson
+44 (0)208 682 9494

Financial Dynamics
Julia Philips / Lucy Briggs
+44 (0)20 7831 3113


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