Completion of Alzheimer's Plasma Biomarker Study

RNS Number : 2019A

Proteome Sciences PLC

28 March 2012

 



Proteome Sciences plc

("Proteome Sciences")

PRESS RELEASE

Completion of Alzheimer's Plasma Biomarker Study

Data Demonstrates Significant Diagnostic and Prognostic Utilities

28 March 2012, London, UK -  Proteome Sciences, in collaboration with the National Institute for Health Research (NIHR) Biomedical Research Centre for Mental Health and Merck Millipore, today announces the completion of the large, 1,000 sample Alzheimer's Disease (AD) biomarker validation study.  Preliminary results indicate that these biomarkers have significant potential diagnostic and prognostic utility that could form the basis of a series of simple blood tests for the diagnosis and management of this debilitating disease.

Three biomarker panels in blood, each containing between 11 and 16 proteins, have been identified which can discriminate between mild cognitive impairment (a syndrome often preceding AD), AD and control groups respectively. Proteome Sciences is filing further intellectual property around these panels which include and combine markers covered by existing patents with additional newly validated biomarkers. 

It is currently estimated that 60% of people with AD have not been properly diagnosed and therefore are not being given vital drugs and care. The capability to distinguish between the levels and progression of the disease will enable drug developers to substantially improve patient care and people with mild cognitive impairment are likely to benefit the most from such disease-modifying drugs.

Currently AD biomarker and diagnostic development involves either cerebrospinal fluid (CSF) measurements, which requires invasive lumbar punctures or brain imaging via magnetic resonance imaging.  Neither of these approaches are well-suited for use outside clinical trials.  In contrast, commercialisation of a diagnostic based on plasma biomarkers would provide a screening approach for the disease.

Presenting the data at RASAD 2012 (Research & Standardisation in Alzheimer's Disease Conference) in Melbourne, Australia, Professor Simon Lovestone, Director of the NIHR BRC for Mental Health and Director of Research King's Health Partners Academic Health Sciences Centre, London, commented: 

"These results represent the largest study of plasma biomarkers to date, that we are aware of, and confirm our earlier findings that there are valuable diagnostic and prognostic signals in plasma.  As new treatments for Alzheimer's disease are being developed, there is an increasing need for accurate and accessible markers of disease severity and progression.  We will move quickly to support the development of clinical tests based on these biomarker panels."

Dr Simon Ridley, Head of Research from Alzheimer's Research UK commented: 

"There is an acute need for reliable diagnostic tools for Alzheimer's disease, and this research on blood biomarkers is making good progress. These diagnostic tests have a way to go, but we look forward to seeing the approach develop towards clinical tests to harness these biomarkers."

Dr. Linda Meeh, Director of Marketing for Immunoassays and Multiplexing, from Merck Millipore noted:

"There is a need for assay tools that enable greater insight into the biochemical changes in key proteins in neurodegenerative disease research. The panels of biomarkers are part of the MILLIPLEX^® map portfolio, based on Luminex^® xMAP^® technology.  These assays provide a high-throughput, multiplexed method that is more specific and sensitive than traditional single analyte methods, and provide the advantage of generating more data with less sample."

Christopher Pearce, CEO of Proteome Sciences, said: 

"This study is a major step towards a series of simple blood tests that would facilitate the early diagnosis and management of Alzheimer's. Such tests will address a major unmet need and will have widespread application and commercial value.  Our analysis of the data from this large study provides individual markers and defined marker panels that have good diagnostic and prognostic utility.  Given the complexity of the data, we expect that the full analysis will introduce further biomarkers to the three panels announced today over the coming months and we are hopeful that collectively these will benefit patients and families suffering from the devastating effects of Alzheimer's."

ENDS

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Notes to Editors:

About Alzheimer's Plasma Biomarker Study

The study focused on the analysis of over 40 protein biomarkers in a group of 1,000 individuals comprising patients with a clinical diagnosis of mild to moderate Alzheimer's disease or Mild Cognitive Impairment and appropriate age- and sex-matched controls. For each individual a single sample of blood plasma was tested. The levels of each blood protein were compared with over 200 different clinical parameters to determine those proteins most effective at making an early diagnosis of AD, predicting the current duration of disease and predicting the likely future course of cognitive decline. To ensure that the data obtained was free of bias all samples were randomised before testing and the testers had no knowledge of the health status of any of the patients prior to un-blinding of the study. Combinations of statistical methods were applied to interpret the >100,000 individual datapoints and generate the optimum protein panels for each indicated use.

About Alzheimer's Disease

Alzheimer's disease is the most common cause of dementia, accounting for around two thirds of cases in the elderly. Typical symptoms of Alzheimer's include memory problems including regularly forgetting recent events, names and faces. Alzheimer's typically causes confusion and disorientation, language difficulties, reduced judgement, and mood, behavioural or personality change. As a progressive disease, the symptoms of Alzheimer's become worse over time and can lead to dependence on round-the-clock care. The economic impact of dementia is greater than those of heart disease and cancer combined.

About the NIHR

The National Institute for Health Research provides the framework through which the research staff and research infrastructure of the NHS in England is positioned, maintained

and managed as a national research facility.  The NIHR provides the NHS with the support and infrastructure it needs to conduct first class research funded by the Government and its partners alongside high-quality patient  care, education and training. Its aim is to support outstanding individuals (both leaders and collaborators), working in world class facilities (both NHS and university), conducting leading edge research focused on the needs of patients. www.nihr.ac.uk

About the NIHR Biomedical Research Centre for Mental Health

The National Institute for Health Research (NIHR), Biomedical Research Centre for Mental Health at the South London and Maudsley NHS Foundation Trust and the Institute of Psychiatry, King's College London, is one of 12 national biomedical research centres created through the partnership of a leading NHS provider and an outstanding university.  The Centres are funded by the UK's Department of Health through the National Institute for Health Research. The BRC for Mental Health was selected through open competition by an international expert selection panel and is distinguished as a leader in scientific translation. Its purpose is to accelerate the translation of fundamental biomedical research into clinical practice for patient benefit. One way it will achieve this is through the early adoption of new insights in technologies, techniques and treatments for health improvement.  It is the only biomedical research centre specializing in mental health in the UK.

About King's College London

King's College London is one of the top 30 universities in the world (2011/12 QS international world rankings), and was The Sunday Times 'University of the Year 2010/11', and the fourth oldest in England. A research-led university based in the heart of London, King's has nearly 23,500 students (of whom more than 9,000 are graduate students) from nearly 140 countries, and some 6,000 employees. King's is in the second phase of a £1 billion redevelopment programme which is transforming its estate. King's has an outstanding reputation for providing world-class teaching and cutting-edge research. For more information, visit: http://www.kcl.ac.uk 

King's College London and Guy's and St Thomas', King's College Hospital and South London and Maudsley NHS Foundation Trusts are part of King's Health Partners. King's Health Partners Academic Health Sciences Centre (AHSC) is a pioneering global collaboration between one of the world's leading research-led universities and three of London's most successful NHS Foundation Trusts, including leading teaching hospitals and comprehensive mental health services. For more information, visit: www.kingshealthpartners.org. 

About Proteome Sciences

Proteome Sciences is a global leader in applied proteomics and peptidomics offering high sensitivity, proprietary technologies for protein and peptide biomarker discovery, validation and assay development.

Its PS Biomarker Services™ uses isobaric and isotopic Tandem Mass Tag^® (TMT^®) workflows developed on the latest Orbitrap Velos and TSQ Vantage mass spectrometers to deliver rapid, robust and reproducible biomarker assay development for customers in the pharmaceutical, diagnostic and biotechnology sectors. Services are provided from its ISO 9001: 2008 accredited facilities in Frankfurt, Germany. By combining Selected Reaction Monitoring (SRM) and TMT workflows highly multiplexed assays can be developed rapidly and are suitable for screening hundreds of candidate biomarkers in larger validation studies and can be transferred for immunoassay development. The Company's own research has discovered a large number of novel protein biomarkers in key human diseases and is focused mainly in neurological/neurodegenerative conditions and in cancer. It has discovered and patented blood biomarkers, including Alzheimer's disease, stroke, brain damage and lung cancer for diagnostic and treatment applications that are available for license or are already outlicensed. Proteome Sciences, based in Cobham, UK, with facilities in London and Frankfurt, delivers outsourced proteomics services and proprietary biomarkers/biomarker assays to pharmaceutical, biotechnology and diagnostics companies.

Visit:  http://www.proteomics.com.

About Merck Millipore

Merck  Millipore  is the Life Science division of Merck KGaA of Germany and offers  a  broad  range  of  innovative, performance products, services and business  relationships  that  enable  our  customers' success in research, development  and  production  of biotech and pharmaceutical drug therapies.  Through dedicated collaboration on new scientific and engineering insights, and  as  one  of  the  top  three  R&D  investors in the Life Science Tools industry,  Merck  Millipore  serves as a strategic partner to customers and helps advance the promise of life science.

Headquartered  in  Billerica, Massachusetts, the division has around 10,000 employees, operations in 67 countries and 2010 revenues of EUR 1.7 million.  Merck Millipore operates as EMD Millipore in the U.S. and Canada.

Note: Merck KGaA or Merck shall mean Merck KGaA, Darmstadt, Germany

 

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