Вы находитесь на странице: 1из 4

ExonHit Launches First Product in Alzheimer

PARIS--(BUSINESS WIRE)--Regulatory News:


ExonHit Therapeutics (Paris:ALEHT) is actually pleased to announce that AclarusDx(TM)
Alzheimer's test (formerly referred to become able to as EHT Dx21), its blood-based test for your
detection involving Alzheimer's disease (AD), is now available as a Analysis Use only (RUO) item for
pharmaceutical companies and leading academic centers conducting clinical trials inside
Alzheimer's disease.
"Alzheimer's disease can be a multi-factorial and a complex pathology. Currently, its diagnosis is
principally according to clinical criteria, i.e., relies about subjective measurements. Such As topics
that are certainly not correctly characterized could easily boost the particular price of a clinical
study and also potentially jeopardize its success," commented Loc Maurel, M.D., President in the
Management Board associated with ExonHit Therapeutics. "The use regarding AclarusDx(TM)
Alzheimer's test could probably be a new tremendous asset for the pharmaceutical industry since it
has the possible to spot populations regarding patients which may well benefit the most through
therapeutic advances in AD."
AclarusDx(TM) Alzheimer's test is a reproducible, objective, and non invasive test. The blood trial
will be just about all that is required from your patient, so which it can be implemented at virtually
any recruiting site. Unlike mind imaging techniques or even cerebrospinal fluid sampling, simply no
unique equipment as well as health-related facilities are required and furthermore the ease in the
procedure must enhance volunteers' willingness to always be able to be involved in trials. The idea
may also boost the recruitment speed and allow the actual clinical trial sponsor to incorporate
investigating centers other than the primary hospitals. Any time utilized in mixture using neurocognitive tests, AclarusDx(TM) Alzheimer's test could help pharmaceutical companies running
clinical trials to add patients fulfilling clinical criteria regarding AD and whom share the typical
transcriptional profile which has been correlated to AD. Hence, AclarusDx(TM) Alzheimer's test
could lower the actual trial's "background noise" and also potentially lead to a a lot better study
outcome by simply selecting a more homogeneous research population.
In 2008, 43 clinical trials involving approximately 10,700 patients had been initiated for you to test
new AD therapies. in 2009, 70 AD studies involving around 14,000 patients had been started (1).To
recruit 1 Alzheimer patient, three as well as four people possess being screened (2).
The launch of AclarusDx(TM) Alzheimer's test as a RUO method is the really first step in ExonHit's
commercial strategy in which trial sponsors sends individual blood biological materials pertaining to
analysis throughout ExonHit's GLP-compliant laboratories inside the US. Inside parallel, the
company can be preparing the particular launch associated with its item within the clinical in vitro
diagnostics (IVD) industry with partners. ExonHit is anticipating the CE marking throughout Q4
2010 for a European launch in Q1 regarding 2011. Concerning US marketing and also advertising
approval, discussions have been initiated using the FDA in order to define the precise regulatory
road to meet IVD requirements.
ExonHit Therapeutics features Condominium For Sale Annapolis MD a unique approach to
Alzheimer's disease using both therapeutic (EHT 0202, its lead candidate within Cycle II) and also

diagnostic applications (AclarusDx(TM) Alzheimer's test) inside clinical development. Pertaining To


its study along with development operate in AD diagnostics and more not too long ago therapeutics,
ExonHit can be counseled by simply experts through each factors of the Atlantic: Jeffrey Cummings,
M.D., Serge Gauthier, M.D., Zaven Khachaturian, Ph.D., Peter Snyder, Ph.D. and also Bruno Vellas,
M.D..
About ExonHit's Alzheimer Scientific Advisory Board
The Board advises the Organization on the development of novel therapies and additionally the
clinical progression of molecular diagnostics for that research community, your pharmaceutical
sector as well as the healthcare neighborhood in particular having a particular emphasis about
strategies for disease prevention.
Jeffrey Cummings, M.D., will always be the Augustus Rose Professor associated with Neurology,
Director in the Mary S. Easton center pertaining to Alzheimer's Disease Research, as well as
Director of the Deane F. Johnson center with regard to Neurotherapeutics in the David Geffen
University involving Medicine in UCLA (Los Angeles, CA). He is the 2008 people receiving your
National Alzheimer's Association's Ronald and Nancy Reagan Study Award. Professor Cummings
provides authored nearly 1,000 articles, chapters, as well as abstracts upon Alzheimer's disease as
well as other mind diseases.
Serge Gauthier, M.D., can be a Professor within the Departments of Psychiatry, Neurology &
Neurosurgery, and also Medicine at McGill university (Montral, Canada). He can in addition be
Director in the Alzheimer's Disease as well as related Disorders Unit in the McGill center for
Scientific studies inside Aging, Douglas Mental Well Being School Institute. Within 2006, he
received the particular "Prix Ambassadeur" in the Montral Palais des Congrs and in 2007 has
been elected as among the actual Very Best Doctors in North America.
Zaven Khachaturian, Ph.D., can be a Senior Associate regarding Khachaturian and Associates
(Potomac, MD). He was formerly President as well as CEO of the Lou Ruvo brain Institute (Las
Vegas, NV) that is devoted for you to obtaining cures regarding memory, mood and movement
disorders related with dementia diseases (including Alzheimer's). Also, for nearly a couple of
decades, Dr. Khachaturian led the Alzheimer's disease analysis department in the U.S National
Institutes regarding Health. Inside 1984, Dr. Khachaturian posited the unifying theory of mind
aging, which may be now referred in order to because the "Calcium Hypothesis involving brain
Aging". Zaven Khachaturian is actually a former part of the particular FDA's Peripheral along with
Central nervous System Advisory Committee as well as remains as advertisement hoc consultant.
Peter Snyder, Ph.D., can be Vice President regarding Study for the Lifespan Hospital System
(including Rhode Island Hospital) and Professor of Neurology in the Alpert medical Institution
involving Brown School (Providence, RI). Earlier within his career, Dr. Snyder was an Early Clinical
Leader along with Director in Pfizer Pharmaceutical's Global Analysis & Development laboratories
throughout Groton (Connecticut, USA). Inside 2008, he ended up being honored like a FultonCushing Lecturer within the Department of Neurosurgery at the Yale University Or College school of
Medicine. Dr. Snyder may always be the Associate Editor associated with brain and Cognition, and
he maintains an energetic research program in Alzheimer's disease.
Bruno Vellas, M.D., is really a Professor associated with Internal Medicine & Geriatrics along with
heads the actual Alzheimer's Disease Clinical Study Middle as well as the Gerontopole in Toulouse
College medical center (Toulouse, France). He is a Principal investigator inside your European
Alzheimer's Disease Consortium and also co-leads the actual Epidemiology and Sociology involving

Aging analysis group from Inserm Unit 558.


About Alzheimer's disease
Alzheimer's disease is truly a progressive neurodegenerative issue that is probably the particular
most frequent cause associated with dementia in the elderly. Worldwide, an estimated 26.6 million
folks had Alzheimer's disease in 2006. This range is set to quadruple by 2050 to more than 100
million; 1 in 85 folks worldwide will be living with the disease (3). Throughout France alone, 800,000
people, or perhaps 18% involving the populace over-75, have got Alzheimer's disease (4).
Note: AclarusDx(TM) Alzheimer's test is available as becoming a research Use Just product. The idea
can end up being a study device and should not necessarily become accustomed to diagnose patients
in the clinical diagnostic environment until its registration as an IVD product within Europe and also
inside the US
About ExonHit Therapeutics
ExonHit Therapeutics (Alternext: ALEHT) is really a fast-emerging healthcare player active
throughout each therapeutics along with diagnostics. the organization is actually applying its
proprietary technology, based about the analysis of alternative RNA splicing, for you to develop
innovative molecular diagnostic tests as well as therapeutics regarding neurodegenerative and
cancer indications. ExonHit features a well balanced investment strategy along with internal
development applications as well as strategic collaborations, particularly along with bioMrieux
along with Allergan.
ExonHit will be headquartered within Paris, France and has U.S. offices in Gaithersburg, Maryland.
the organization is outlined upon Alternext of NYSE Euronext Paris. With Regard To much more
information, please visit http://www.exonhit.com.
Disclaimer
This press release contains elements that are not historical facts including, without limitation,
specific statements in long term expectations as well as other forward-looking statements. Such
statements are based on management's existing views along with assumptions and also involve
recognized and unidentified risks as well as uncertainties in which could trigger actual results,
performance as well as events to always be able to differ materially through those anticipated.
In addition, ExonHit Therapeutics, its shareholders, and also its affiliates, directors, officers,
advisors and also employees have got certainly not verified your accuracy of, and also make no
representations or perhaps warranties throughout relation to, statistical information as well as
predictions contained within this press release that get been taken or even derived coming from 3rd
party sources as well as sector publications, as well as such statistical information along with
predictions are employed within this press launch with regard to details purposes only.

Lastly, this press launch may become drafted within the


French and English languages. Inside an event of
differences involving the texts, the particular French
language version shall prevail.
References
(1) www.clinicaltrial.gov
(2) CRO Marketplace Surveillance statement - IMS
Wellness Global, March 2006 (Pharmaceutical/Biotech Industry as well as Clinical Development)
(3) Brookmeyer R, Johnson E, Ziegler-Graham K, MH Arrighi (July 2007). "Forecasting the particular
global burden associated with Alzheimer's disease". Alzheimer's and Dementia 3 (3): 186-91
(4) plan Maladie d'Alzheimer 2004-2007- Ministre des solidarits, de la sant et de la famille
Photos/Multimedia Gallery Available:
http://www.businesswire.com/cgi-bin/mmg.cgi?eid=6112197&lang=en

Вам также может понравиться