Cambridge Cog Regulatory News (COG)

3 June 2014

Cambridge Cognition Holdings Plc

('Cambridge Cognition' or the 'Company')

Launch of the first two products on the new Cantab Connect platform

Cambridge Cognition Holdings plc, (AIM: COG), which specialises in computerised neuropsychological tests including those enabling the early detection of dementia, announces the launch of the first two iPad-based products on its new Cantab Connect digital platform, for use in clinical trials. Both of these products address the market need to assess the safety of new drugs in development, an addressable market which the Company estimates to be in excess of £60m.

The Clinical Trials Information System Adverse Effects (CTIS-AE) product enables fast, sensitive and reproducible measurement of cognitive impairment in Phase I trials. This enables early informed decisions to be made about the cognitive safety of new drugs, reducing the risk of costly late-stage failure in clinical development. Furthermore, CTIS-AE complies with FDA reviewer guidance which states that data submissions that include special studies intended to identify adverse events, such as decreased cognitive function, will be given more credence than those which do not. CTIS-AE should therefore provide a valuable tool to the numerous companies developing drugs belonging to classes that have a known cognitive safety risk.

The CTIS-Abuse Liability (CTIS-AL) product is a computerised patient-report system enabling rapid, accurate and paperless measurement of the abuse potential for investigational drugs in clinical trials. It enables companies to comply with FDA guidance which states that drug products with the potential for abuse should be assessed for liability. Current practice in abuse liability trials relies largely on pen and paper questionnaires which have inherent inaccuracies. CTIS-AL provides a digital solution, with automated administration and data collection, reducing trial workloads and costs and improving data quality. This product will meet the increasing demand for abuse liability studies to assess the addictive qualities of drugs.

Both products (CTIS-AE and CTIS-AL) are designed for GCP-compliant studies. The products comply with the European Clinical Trials Directive 2001/20/EC and meet FDA regulations for computerised systems used in clinical trials and 21 CFR Part II.

Andy Blackwell, Chief Scientific Officer, comments: "Sensitive, intuitive and fast, Cantab Connect products provide clinical trial professionals with the first digital platform for all aspects of cognitive assessment. As well as significantly reducing errors and the labour-intensity of such work, touchscreen assessment and electronic data capture will accelerate decision making. Our first two new products on the new platform are focused on areas of particular concern to drug developers; adverse effects and abuse liability. CTIS-AE is designed to enable early informed decisions in Phase I trials on the cognitive safety of compounds, reducing the risk of costly late stage failure. Similarly, CTIS-AL will facilitate compliance with regulatory guidance, which calls for all drug products with the potential for abuse to be assessed."

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About Cambridge Cognition

Cambridge Cognition is a world leading provider of computerised cognitive assessment products. The company's range of touch-screen CANTAB™ neuropsychological tests, highly validated over one thousand peer-reviewed publications, are used by both academic scientists in their research, and clinical researchers in the pharmaceutical industry, to maximise knowledge of cognitive function. In addition, the company is committed to broadening the access to this technology and is developing clinical healthcare products under the Cantab mobile brand, to improve the monitoring, management and maintenance of cognitive health and wellbeing. Using these assessments, clinicians can identify and stratify patients so that patient referrals are accurate and efficient, enabling health and social care providers to deliver more effective advice, treatments and care - leading to better outcomes for patients and their families.