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:
Onyvax
Dr Anthony Walker / Robert Johnson
+44 (0)208 682 9494
Financial Dynamics
Julia Philips / Lucy Briggs
+44 (0)20 7831 3113
