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A 3-year follow-up of cognitive functions in 1,200 aged and frail
individuals
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Search of blood biomarkers associated with early cognitive decline
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First participation of ExonHit in an external prospective study
Regulatory News:
ExonHit Therapeutics (Paris:ALEHT) together with Toulouse University
Hospital and l’Institut de Recherche Pierre Fabre (IRPF) will
participate in the Multidomain Alzheimer Preventive Trial (MAPT). The
study’s main objective is to assess the efficacy of a multidomain
(nutrition, physical exercise, cognitive stimulation) intervention
associated with an omega-3 treatment in preventing the decline of
cognitive functions in aged and frail individuals.
“We are going to apply our validated AclarusDx
TM
diagnostic platform to the study samples in order to identify early
blood biomarkers of Alzheimer’s disease,” commented Loïc Maurel,
M.D., President of the Management Board of ExonHit Therapeutics. He
added: “Access to such biomarkers would be a major asset for
developing new drugs against this disease.”
The clinical study, which includes several memory centers in France, is
lead by Professor Bruno Vellas, M.D., Head of the Alzheimer’s Disease
Clinical Research Center and of the Gérontopôle, Toulouse University
Hospital, France.
“Early detection of Alzheimer’s disease, before signs of dementia
appear and taking action at a very early stage is key to an improved
patient care,” stated Professor Vellas.
Over the course of 3 years, 1,200 frail individuals, of both genders and
aged 70 or more will be monitored. During this period, the status of
their cognitive functions and of their functional capacity will be
assessed in order to identify the ones who evolve towards dementia, in
particular one of an Alzheimer’s type, and to evaluate the preventive
measures that are tested.
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Annual blood samplings will allow for transcriptome analysis in
order to:
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(i)
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Develop a signature that will identify asymptomatic subjects at risk
of having an impairment of their cognitive functions, which could
evolve towards a dementia (Alzheimer’s or other) and
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(ii)
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Search for new biological markers for the diagnosis and prognosis of
cognitive diseases such as Alzheimer’s, with the long-term objective
of developing new, more effective treatments.
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Financial terms of the 3-party agreement were not disclosed.
About the MAPT study
The primary objective of the study is to assess the efficacy of adding
omega-3 fatty acids, or of a multidomain intervention, or of their
combination on the evolution of an aged and frail person’s cognitive
functions. A frail person is defined by one of the following criteria:
(i) a subjective cognitive complaint spontaneously declared to the
family doctor, or (ii) an inability to perform a key daily activity, or
(iii) a slow walk.
1,200 frail individuals of both genders and aged 70 or more, are
randomized in 4 groups: (i) group omega-3 fatty acids, (ii) group
multidomain intervention + placebo, (iii) group multidomain intervention
+ omega-3 fatty acids, (iv) placebo group. The primary objective is the
evaluation of the cognitive functions. Secondary objectives are: (i) the
evaluation of the efficacy of each intervention strategy on the
evolution of the functional capacities and on the prevention of
dependence, (ii) the safety evaluation and long-term tolerance of
omega-3 fatty acids, (iii) the study of compliance and aherence to the
multidomain intervention program (1).
Study completion is planned in 2013 and publication of results, in 2014.
About Alzheimer’s disease
Alzheimer’s disease is a progressive neurodegenerative condition that is
the most frequent cause of dementia in the aging population. An
estimated 26.6 million people worldwide had Alzheimer in 2006. This
number is anticipated to quadruple by 2050 to more than 100 million; 1
in 85 persons worldwide will be living with the disease (2). In France
alone, 800,000 people, or 18% of people above 75 years old, have
Alzheimer’s disease (3).
About ExonHit Therapeutics
ExonHit Therapeutics (Alternext: ALEHT) is a fast emerging healthcare
player active in both therapeutics and diagnostics. The Company is
applying its proprietary technology, based on the analysis of
alternative RNA splicing, to develop innovative molecular diagnostic
tests and therapeutics for neurodegenerative and cancer indications.
ExonHit has a balanced investment strategy with internal development
programs and strategic collaborations, in particular with bioMérieux and
Allergan.
ExonHit is headquartered in Paris, France and has U.S. offices in
Gaithersburg, Maryland. The Company is listed on Alternext of NYSE
Euronext Paris. For more information, please visit http://www.exonhit.com.
Disclaimer
This press release contains elements that are not historical facts
including, without limitation, certain statements on future expectations
and other forward-looking statements. Such statements are based on
management’s current views and assumptions and involve known and unknown
risks and uncertainties that could cause actual results, performance or
events to differ materially from those anticipated.
In addition, ExonHit Therapeutics, its shareholders, and its
affiliates, directors, officers, advisors and employees have not
verified the accuracy of, and make no representations or warranties in
relation to, statistical data or predictions contained in this press
release that were taken or derived from third party sources or industry
publications, and such statistical data and predictions are used in this
press release for information purposes only.
Finally, this press release may be drafted in the French and English
languages. In an event of differences between the texts, the French
language version shall prevail.
References
(1) Gillette-Guyonnet S, Andrieu S, Dantoine T, Dartigues JF, Touchon J,
Vellas B; MAPT STUDY GROUP. Commentary on a roadmap for the prevention
of dementia II. Leon Thal Symposium 2008. “The Multidomain Alzheimer
Preventive Trial (MAPT): a new approach to the prevention of Alzheimer’s
disease. Dement. 2009 Mar; 5 (2): 114-21
(2) Brookmeyer R, Johnson
E, Ziegler-Graham K, MH Arrighi (July 2007). "Forecasting
the global burden of Alzheimer’s disease". Alzheimer's and Dementia
3 (3): 186–91
(3) Plan Maladie d’Alzheimer 2004-2007- Ministère des
solidarités, de la santé et de la famille
ExonHit Therapeutics
Media
Corinne Hoff, +33 1
58 05 47 04
corinne.hoff@exonhit.com
or
ALIZE
RP
Caroline Carmagnol, + 33 6 64 18 99 59
caroline@alizerp.com
or
Investors
Loïc
Maurel, +33 1 53 94 77 00
loic.maurel@exonhit.com
