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News for 'AMBS' - (Amarantus Outlines LymPro Alzheimer's Diagnostic Development Strategy)
SUNNYVALE, Calif., Apr 08, 2013 (BUSINESS WIRE) -- Amarantus BioScience
Holdings, Inc. (OTCQB: AMBS), a biotechnology company discovering and developing
treatments and diagnostics for diseases associated with neurodegeneration and
apoptosis, today announced a development timeline for its LymPro Blood Test for
Alzheimer's disease
("LymPro"). LymPro is
designed to diagnose Alzheimer's disease by
identifying immune-based biomarkers in the blood of
Alzheimer's patients, allowing physicians to
definitively differentiate Alzheimer's disease from
other forms of dementia, a key unmet medical need in the management of
Alzheimer's patients. Human clinical studies for
LymPro with over 160 patients have been completed to date, showing high
sensitivity and specificity for Alzheimer's disease
diagnosis.
"The LymPro assay represents a blood-based peripheral
means to assess the integrity of the regulatory function of the cellular
machinery within the Central Nervous System," said
Amarantus corporate advisor Adam J. Simon, Ph.D.
"Although we all experience various triggers and
assaults on our brain as we age, why do some people succumb to
Alzheimer's while others show cognitive resilience?
The LymPro test can potentially tell us who is susceptible to abnormal
cell-cycle re-entry and who has sufficiently strong regulatory function in their
neurons to arrest cell-cycle re-entry due to triggers such as age, diet, viral
infection, stress, or brain injury that could eventually lead to
Alzheimer's disease."
After establishing the analytical performance of the assay in an outsourced GLP
laboratory, Amarantus plans to conduct a small clinical performance study at an
independent laboratory in the second quarter of 2013 to verify the previously
published findings. During the third quarter of 2013, the Company expects to
initiate a pivotal diagnostic accuracy study (Phase 2) at the same independent
laboratory to generate sufficient data to validate the clinical performance
(sensitivity / specificity) that would support a CLIA launch, with data
available in the first half of 2014. As part of that pivotal study, LymPro will
be evaluated as an "aid to the diagnosis of
Alzheimer's disease." The
Company intends to initiate commercial worldwide sales following assessment of
the validation study data. Thereafter, the Company intends to gain U.S.
clearance or approval for the test through the Food and Drug
Administration's de-novo Pre-market notification
510(k) or Premarket Approval (PMA) process, which would represent a 3-month to
2-year process. Ultimately, the Company believes LymPro could be approved by the
FDA as a companion diagnostic product in combination with one or more
therapeutic products.
"We are excited with the progress and upcoming
activities related to our LymPro Alzheimer's test,
which addresses a market opportunity in excess of $500 million
annually," said Gerald E. Commissiong, President and
Chief Executive Officer of Amarantus. "The FDA has
stated the importance of identifying Alzheimer's at
the earliest stage, as that is where new treatments appear to have the greatest
benefit to patients. We believe LymPro fits well within this overall strategy
and will likely have the dual benefit of improving overall diagnosis paradigms
and accuracy, while also potentially reducing overall healthcare costs if
combined with an appropriate therapeutic product as a companion
diagnostic."
The field of diagnostics for Alzheimer's disease has
been significantly bolstered in recent months with FDA guidance for drug
developers to target experimental therapies of
Alzheimer's disease towards earlier-stage patients,
as well as guidance reducing the burden of proof for drug developers to gain an
approval. In 2010 Eli Lilly & Co. acquired
Alzheimer's diagnostic developer Avid
Radiopharmaceuticals for $800 million, including $300 million up-front,
following Avid's application for marketing approval
to the FDA for florbetapir, a chemical agent used in the diagnosis of
Alzheimer's disease during a PET imaging process.
Amarantus believes that LymPro may have certain advantages over florbetapir,
including the likely cost-effectiveness of LymPro as a simple blood test in
comparison to more expensive neuro imaging techniques.
About Amarantus
Amarantus is a development-stage biotechnology company founded in January 2008.
The Company is focused on developing unique products and proprietary
technologies for the potential treatment and/or diagnosis of Parkinson's
disease, Traumatic Brain Injury, Ischemic Heart Disease and other human
diseases. The Company owns the intellectual property rights to
Mesencephalic-Astrocyte-derived Neurotrophic Factor ("MANF") and is developing
MANF-based products as treatments for neurological disorders where there is a
significant unmet medical need. The Company also is a Founding Member of the
Coalition for Concussion Treatment (#C4CT), a movement initiated in
collaboration with Brewer Sports International seeking to raise awareness of new
treatments in development for concussions and related nervous-system disorders.
For further information please visit www.Amarantus.com.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995. Such statements include, but
are not limited to, statements about the possible progress of the MANF
technology in testing for Parkinson's disease,
statements about expectations, plans and prospects of the development of
Amarantus' diagnostic product candidates for
Alzheimer's and
Parkinson's disease, and the potential market size
for the LymPro test for Alzheimer's disease. These
forward-looking statements are subject to a number of risks, uncertainties and
assumptions, including the risks associated with development of therapeutic drug
candidates, as well as the risks, uncertainties and assumptions relating to the
development of Amarantus' new product candidates, including those identified
under "Risk Factors" in Amarantus' most recently filed Annual Report on Form
10-K and Quarterly Report on Form 10-Q and in other filings Amarantus
periodically makes with the SEC. Actual results may differ materially from those
contemplated by these forward-looking statements Amarantus does not undertake to
update any of these forward-looking statements to reflect a change in its views
or events or circumstances that occur after the date of this presentation.
http://cts.businesswire.com/ct/...05612r1&sid=cmtx4&distro=nx
SOURCE: Amarantus BioScience Holdings, Inc.
CONTACT:
Investor/Media Contact
LHA
Don Markley, Senior Vice President
310.691.7100
dmarkley@lhai.com
Copyright Business Wire 2013
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