NextGen files for intellectual property on dementia biomarkers
· Intention to pursue IP across multiple dementia areas
· Further studies planned to expand patent portfolio
March 13 2012
NextGen Group Plc (AIM: NGG), an AIM listed company providing biomarker discovery services and diagnostic assay development, announces that its subsidiary, NextGen Sciences Dx (NGSDx), has filed for intellectual property (IP) on a combination of protein biomarkers with the potential for diagnosing changes in cognition for patients with early-stage dementia.
Barry McAleer, PhD, CEO of NextGen Sciences Inc and NextGen Sciences Dx, says: "The biomarkers we have identified in cerebrospinal fluid (CSF) have the potential to aid decision-making on how to treat patients who have early-stage dementia (i.e. mild-moderate cognitive impairment), to assist in patient selection for clinical trials and to monitor the effectiveness of drugs in development. It gives us an immediate foothold in a critical healthcare market."
Dementia affects an estimated 36 million people globally in 2010. The number affected is projected to grow to 65 million by 2030 (Source: ADI 2009). The number suffering from cognitive impairments, which are not severe enough to be classified as dementia, is significantly higher.
Biomarkers can be used to identify the existence and/or progression of a disease. They are also commonly used in clinical trials to aid in patient selection and to evaluate the effectiveness of a drug. There is a significant need for biomarkers to monitor and diagnose CNS disorders both within the patient care and drug development industries.
There are currently almost 500 active dementia/cognitive clinical trials globally (Source: www.clinicaltrials.gov), a number that is likely to continue to rise given the increasing prevalence of these disorders. Over 90 pharma/biotech companies are conducting clinical trials in relation to diseases with a dementia element (Source: Medtrack).
Adds Barry McAleer: "It is clear to us all, that real progress is needed to address the suffering and distress for the millions people affected by dementias. NextGen Sciences Dx was established to help achieve this mission by exploiting the technological capabilities of its sister company, NextGen Sciences Inc. Filing for IP signals the start of our ongoing plans to secure maximum commercial returns on the discoveries we make."
The protein markers were identified using the high precision csfdiscovery43 assay developed by NextGen Sciences Inc. An assay is the procedure for testing the effects of a chemical in an organism. For example, assays are used to test the efficiency of a drug on a sample of patients in a clinical trial.
Barry McAleer comments: "These markers have been identified through collaborations with several US-based academic and clinical centres that bring high quality patient samples and comprehensive clinical data into juxtaposition with our precise assays. Not only will we continue to develop and expand our IP position in cognitive impairment with our current collaborators, but we are actively seeking new collaborations to investigate other dementia areas."
"We continue to build partnerships in other CNS disease/disorder areas as we evaluate the clinical and commercial needs in these areas e.g. Parkinson's disease, Multiple Sclerosis and Traumatic Brain Injury."
Klaus Rosenau, Chairman of NextGen Group PLC, explains: "We are now starting to reap the benefits of the investments we have made in our technology and in the operational restructures we undertook in 2010/2011. The dementia biomarkers project is the first in a number of projects we have in progress as evidence of our vision to create a diagnostics project engine. This engine will continually evaluate, both commercially and scientifically, new opportunities to discover biomarkers and develop products that can enable clinicians and pharmaceutical companies to address disorders of the CNS. Importantly, it provides our investors with a unique and exciting opportunity to access a reduced risk strategy in a market with clear demand and in which successful companies will generate significant returns on investment. Looking to the future, we will continue to build value in our business through establishing a robust IP portfolio, through sale/licencing of biomarkers and assays and through diagnostic/clinical trial testing."
NextGen uses mass spectrometry (a technique for specifically identifying and quantifying biomarkers in samples) as its core technology to discover highly specific protein biomarkers that can be used for diagnostic purposes.
NextGen has already launched a number of "discovery" assays in the Central Nervous System field that measure the presence of proteins that might be impacted by Alzheimer's, Multiple Sclerosis and Parkinson's diseases. These assays provide a platform for the discovery of highly specific and accurate biomarkers that can address critical questions in CNS diseases. The company continues to develop further assays that will enable the discovery of further unique biomarkers for CNS diseases.
In 2010, the total global market for biomarkers was an estimated $13.5 billion and is expected to grow to nearly $33.3 billion by the end of 2015 (BCC Research).
Notes to Editors:
NextGen Group Plc (AIM: NGG) is a provider of biomarker services for pharmaceutical and biotech companies globally through its USA-based subsidiary, NextGen Sciences Inc and a developer of diagnostic markers and assays through its second US-based subsidiary, NextGen Sciences Dx. Using advanced techniques, such as Multiple Reaction Monitoring (MRM) mass spectrometry analysis, the Company is developing a portfolio of robust assays for testing clinical samples for drug safety and efficacy, and the development of personalized treatment for patients.
NextGen Sciences Inc is a wholly owned, operational subsidiary of NextGen Group Plc and is headquartered in Ann Arbor, Michigan, USA. NextGen Sciences' range of services, which include biomarker discovery, assay development, validation and testing are employed by its customers as a key part of the biomarker-based drug and diagnostic development process.
NextGen Sciences Dx is a wholly owned, operational subsidiary of NextGen Group Plc and is headquartered in Boston, Massachusetts, USA. NextGen Sciences Dx utilises the expertise of NextGen Sciences Inc to discover biomarkers and develop assays for point-of-care diagnostics, to assist in patient treatment, for selection of patients for clinical trials and to aid decision-making on efficacy determination for therapeutic development.
For further details please contact:
CEO & Chairman
Tel: +49 (0)160 5516756
Barry McAleer PhD
NextGen Sciences Inc and NextGen Sciences Dx
Tel: +44 (0)7825 413 110
Tel: + 44 (0)20 7107 8000
Seymour Pierce Limited