TORONTO, Jan. 29, 2013 /CNW/ - Amorfix Life Sciences Ltd. announced today that
the Company will collaborate with QPS Holdings, LLC, a leading global provider
of discovery and development services for pharmaceutical, biotechnology and
medical device companies, to further develop and validate its proprietary
Alzheimer's disease diagnostic EP-AD assay.
The companies will work together to obtain and analyze cerebral spinal fluid
(CSF) samples from a variety of Alzheimer's disease patients in various stages
of disease. Amorfix and QPS will perform the studies necessary to validate and
ultimately commercialize the EP-AD assay for use as both a biomarker to
facilitate clinical development of new treatments for AD, and an FDA-approved
early-stage diagnostic test for AD.
"We are looking forward to working with QPS to validate our EP-AD assay," said
Dr. Robert Gundel, Amorfix President and CEO. "Our studies using the EP-AD
assay demonstrate that the EP-AD assay is able to identify early-stage
patients with mild cognitive impairment (MCI) with a sensitivity of 94%,
higher than the sensitivity achieved with other biomarkers used as comparators
in the same study. AD is one of the most active areas of therapeutic
development with more than 93 new treatments being evaluated in clinical
studies. We believe that with QPS, we can bring the EP-AD assay to market
"To promote successful drug development within this challenging indication,
QPS aims to explore new biomarkers that will facilitate early diagnosis and
enable meaningful evaluation of drug efficacy for neurodegenerative
disorders," said Ben Chien, CEO of QPS. "As a leading neuroscience CRO, we
will work with our partner to develop a wide panel of new biomarkers for
experimental and clinical use."
Amorfix will also continue to provide the EP-AD assay for research use to
pharmaceutical and biopharmaceutical companies on a fee for service basis.
About Alzheimer's disease
More than 35 million people worldwide have Alzheimer's disease or some other
type of dementia. AD is most common, and accounts for an estimated 60-80
percent of cases. Barring a major medical breakthrough, as the world's
population ages, cases of dementia are predicted to nearly double every 20
years. By 2040, the number of cases around the world will have quadrupled to
approximately 81 million people. A major stumbling block to the development of
effective therapies is the absence of robust biomarkers for early detection,
and monitoring during clinical trials. A diagnostic tool that can properly
identify patients with early AD is needed in order for current therapeutics to
show effectiveness, and for enrolment of such patients into clinical trials.
QPS is a GLP/GCP-compliant CRO that supports discovery, preclinical, and
clinical drug development. We provide quality services in Neuropharmacology,
DMPK, Toxicology, Bioanalysis, Translational Medicine, and Early Stage & Phase
II - IV Clinical Research to clients worldwide. Our regional facilities and
offices are located in the USA, China, Taiwan, Japan, India, Netherlands,
Austria, Czech Republic, Lithuania, Ukraine, Romania, Poland, Croatia,
Slovenia, Serbia, Bosnia, Hungary, Israel, France, Spain, Germany and the
United Kingdom. Business development offices are maintained throughout the US,
Europe, and Asia. QPS employs more than 1000 professionals at ten sites in
nine countries on four continents. In concert with its global expansion, the
company is proud of and strives to maintain a friendly and caring company
culture at all of its business sites.
QPS has years of experience in neuroscience, as well as global research
resources and capabilities including early in vitro work, proprietary animal
models, focus on CNS-specific DMPK issues such as BBB penetration,
IND-enabling toxicology and clinical research. QPS provides important
technologies for Phase I clinical trials, such as continuous CNS sampling,
PET, MRI and sensitive cognitive testing methods, and is able to apply these
techniques to highly complex Phase II/III trials, including CSF sampling and
functional and structural imaging. Global expertise in this field guarantees
top-level scientific consultation and research services.
For more information, please visit www.qps.com.
Amorfix Life Sciences Ltd. (TSX:AMF) is an early-stage product development
company developing therapeutic antibodies and diagnostics targeting misfolded
protein diseases. Amorfix utilizes its computational discovery platform,
ProMIS™, to predict novel Disease Specific Epitopes (DSEs) on the molecular
surface of misfolded proteins. Using this technology, Amorfix is developing
novel antibody therapeutics and companion diagnostics for cancer and
amyotrophic lateral sclerosis (ALS). In addition, Amorfix has developed two
proprietary technologies to specifically identify very low levels of misfolded
proteins in a biological sample: Epitope Protection™ and AMFIA™, an
ultra-sensitive dual-bead immunoassay. Use of these technologies has generated
the EP-AD assay, a cerebrospinal fluid (CSF) screening test for Alzheimer's
disease (AD) and mild cognitive impairment (MCI), and the A4 assay, an
ultrasensitive method for detecting the hallmark of AD, aggregated
beta-Amyloid, in brain tissue, CSF and blood from animal models of AD. For
more information about Amorfix, visit www.amorfix.com.
The TSX has not reviewed and does not accept responsibility for the adequacy
or accuracy of this release. This information release may contain certain
forward-looking information. Such information involves known and unknown
risks, uncertainties and other factors that may cause actual results,
performance or achievements to be materially different from those implied by
statements herein, and therefore these statements should not be read as
guarantees of future performance or results. All forward-looking statements
are based on the Company's current beliefs as well as assumptions made by and
information currently available to it as well as other factors. Readers are
cautioned not to place undue reliance on these forward-looking statements,
which speak only as of the date of this press release. Due to risks and
uncertainties, including the risks and uncertainties identified by the Company
in its public securities filings, actual events may differ materially from
current expectations. The Company disclaims any intention or obligation to
update or revise any forward-looking statements, whether as a result of new
information, future events or otherwise, unless required by law.
ProMIS™, Epitope Protection™ and AMFIA™ are trademarks of Amorfix Life
Dr. Robert Gundel President and Chief Executive Officer Amorfix Life Sciences
Ltd. Tel: (416) 847-6957 Fax: (416) 847-6899 email@example.com Janet
Clennett Chief Financial Officer Amorfix Life Sciences Ltd. Tel: (416)
847-6926 Fax: (416) 847-6899 firstname.lastname@example.org
SOURCE: Amorfix Life Sciences Ltd.
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