IXICO Selected as Imaging Analysis Partner Within the EPAD Initiative
January 2015, IXICO plc (Ticker: IXI) (“IXICO” or the “Company”), the brain health company, announces today its selection as a partner within The European Prevention of Alzheimer’s dementia Initiative (EPAD), a novel collaboration between academic and private sectors to test innovative treatments for the secondary prevention of Alzheimer’s dementia.
The 5-year programme is part of the Innovative Medicines Initiative (IMI), a joint undertaking between the European Union and the European Federation of Pharmaceutical Industries and Associations, (EFPIA). EPAD will establish a European-wide register of 24,000 participants, of which 1,500 will be invited to participate in trials to test new treatments for prevention of Alzheimer’s dementia.
As part of this programme, IXICO will provide its TrialTracker™ platform to collect and manage imaging data in combination with its Assessa medical device to identify subjects who are most likely to benefit from treatment.
Background to the EPAD programme
Previous attempts to bring new drugs for Alzheimer’s disease to the market have been disappointing despite a high level of investment. However, the realisation that Alzheimer’s disease is a progressive disorder and that early intervention may be more effective has led to research efforts being focused on prevention. The goal of the initiative is the prevention of dementia in people with evidence of the disease (such as biomarker abnormalities as identified by specific tests), who still may have little or no complaints or clinical symptoms. New tools and methods now allow the identification of patients in the early stages of Alzheimer’s disease. This creates an opportunity to have new treatment options investigated in clinical studies early on. A difficulty however remains with the large number of patients and study sites needed to confirm a therapeutic effect within a limited span of time. In contrast to several pharmaceutical companies and academic institutions pursuing this in isolation, a joint effort clearly has advantages: the identification and referral of the concerned patients is accelerated and several treatment options can be tested rapidly within one same trial. Therefore, EPAD aims to develop a platform using existing information from national or regional patient cohorts or register studies, which have already identified potential patients. Through EPAD, the undertaking of better, adaptive, multi-arm proof of concept studies for early and accurate decisions on the ongoing development of drug candidates or drug combinations is facilitated. All data collected from the cohort and trial will become publically available for analysis to improve disease models in the pre-dementia phase of Alzheimer’s disease.
Professor Craig Ritchie, EPAD Co-coordinator and Professor of the Psychiatry of Ageing at the University of Edinburgh, said:
“EPAD is part of a global initiative that will make a fundamental difference to the understanding and management of Alzheimer’s disease in people with very early or no symptoms at all. This could be a game-changer. It is only possible because of the absolute commitment of academics, industry, policy makers and the public to work hand in hand to defeat this global threat.”
Jean Georges, Executive Director of Alzheimer Europe, said:
“Preventing the development of dementia in biomarker-positive people would be a fantastic step forward in our fight against Alzheimer’s disease. The EPAD and its novel trial concept will hopefully help speed up the drug discovery progress and bring us closer to this ambitious aim.”
Derek Hill, CEO of IXICO said:
“We are extremely pleased to join distinguished academic and industry specialists in this ground-breaking pan-European initiative and look forward to working with our colleagues to help improve the prevention, diagnosis and management of dementia.”
IXICO, the brain health company, uses its innovative and proprietary digital platform technologies to help those involved in researching and treating serious diseases to make rapid decisions and improve patient outcomes. Established since 2004, IXICO has significant experience in working with global pharmaceutical and biotechnology companies in dementia clinical studies and other neuro-degenerative disorders including Huntington’s disease and Multiple Sclerosis.
For more information about IXICO, please visit www.ixico.com.
The EPAD project is part of a global effort in the fight against Alzheimer’s disease, which also includes initiatives such as the Global Alzheimer Platform. The EPAD Project is a major European initiative to create a novel environment for testing numerous interventions targeted at the prevention of Alzheimer’s dementia defined as a delay in the onset of clinical symptoms among people with preclinical evidence for AD pathology (i.e. preclinical AD as per NIA-AA and similar definitions) and a delay in the onset of clinical dementia among people with such evidence who already show some clinical symptoms (i.e. MCI due to AD or prodromal AD and similar definitions).
EPAD is mainly sponsored by the European Commission and the European pharmaceutical industry (via EFPIA) under the auspices of the Innovative Medicines Initiative Joint Undertaking (IMI JU). The EPAD programme has an initial budget of €64M distributed across a total of 35 partners from the private and academic sectors:
The project is divided into eight Work Packages with four Scientific Advisory Groups. The trial will be delivered through approximately 30 study sites within six country/regional areas.
While the EPAD platform will be designed to help testing both pharmacological and non-pharmacological interventions, initially the focus will be on testing drugs and drug combinations to ensure a greater chance of success for clinical trials. The EPAD programme will initially run for five years.
For more information, contact firstname.lastname@example.org or visit www.ep-ad.org.
About the EPAD Platform/Register
EPAD aims to develop a platform using existing information. The EPAD platform will draw European participants, whose records are already part of existing national/regional cohort or register studies, into an EPAD register of approximately 24,000 people. From this group, 6,000 people will be asked to join a pan-European EPAD Cohort for consistent, longitudinal follow-up, and approximately 1,500 of them will eventually be invited to enter the EPAD Proof of Concept Trial. This approach aims to ensure EPAD has access to an at-risk population showing biomarker evidence of Alzheimer’s disease prior to the development of dementia.
About the Innovative Medicines Initiative
The Innovative Medicines Initiative (IMI) is Europe's largest public-private initiative aiming to speed up the development of better and safer medicines for patients. IMI supports collaborative research projects and builds networks of industrial and academic experts in order to boost pharmaceutical innovation in Europe. IMI is a joint undertaking between the European Union and the European Federation of Pharmaceutical Industries and Associations, EFPIA.
More information can be found at www.imi.europa.eu.
The research leading to these results has received support from the Innovative Medicines Initiative Joint Undertaking under grant agreement n° 115736, resources of which are composed of financial contribution from the European Union's Seventh Framework Programme (FP7/2007-2013) and EFPIA companies’ in kind contribution.
Derek Hill, CEO
Susan Lowther, Chief Financial Officer
Charles Spicer, VP Corporate Development
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