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Amorfix enters into agreement with a major global pharmaceutical company for Alzheimer’s disease diagnostic

January 22, 2014

TSX: AMF

TORONTO, Jan. 22, 2014 /CNW/ – Amorfix Life Sciences Ltd. announced
today that the Company has signed an agreement with a major global
pharmaceutical company to use the human Alzheimer’s disease diagnostic
assay in phase 1 clinical studies.

Amorfix has granted its collaborator access to its proprietary EP-AD
assay technology and the Company will complete assay optimization and
validation prior to using the assay as part of a clinical trial to
investigate the effects of a novel therapeutic for the treatment of
Alzheimer’s disease. The terms of the agreement have not been
disclosed.

“We are very excited to be working with a world-class pharmaceutical
company with the resources and expertise to assist in the further
development our human Alzheimer’s disease diagnostic assay technology.
The Company has worked very hard to create a diagnostic test that can
identify patients with early-stage disease and we are gratified to have
the opportunity to assist in the clinical development of new
therapeutics that may offer improved treatment options for Alzheimer’s
disease patients” said Dr. Robert Gundel, Amorfix President and CEO.
“In addition, this agreement is an example of our business plan to
establish effective partnerships and strategic alliances with companies
that have the resources and expertise to help advance our products to
clinical development and commercialization”.

The EP-AD diagnostic assay is capable of identifying early-stage
Alzheimer’s disease patients and patients with mild cognitive
impairment (MCI) who are at high risk of developing Alzheimer’s
disease. The EP-AD assay measures levels of Abeta aggregates, a known
biomarker of Alzheimer’s disease, and can also be used to monitor the
effects of Alzheimer’s disease treatments on Abeta aggregates, the
building blocks of plaques that form in the brains of people with
Alzheimer’s disease.

About the EP-AD Assay

The EP-AD Assay detects levels of aggregated Abeta in cerebrospinal
fluid (CSF) samples. Results with the assay show that there is a
significant increase in aggregated Abeta levels in CSF samples from
Alzheimer’s disease patients and patients with mild cognitive
impairment (MCI) compared to age-matched control subjects. Studies with
nearly 200 CSF samples 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. In addition, there is
a statistically significant correlation between aggregated Abeta levels
and mini-mental state examination (MMSE) scores in normal aged
individuals suggesting that the EP-AD test may be able to capture the
transition from normal aging to MCI.

About Alzheimer’s Disease

More than 35 million people worldwide have Alzheimer’s disease or other
types of dementia. Alzheimer’s Disease is the most common type of
dementia and accounts for an estimated 60-80 percent of cases. As the
population around the world ages, the incidence of Alzheimer’s disease
is predicted to increase significantly. Barring a significant medical
breakthrough, predictions are that cases of dementia will nearly double
every 20 years, and by 2040 the number of cases around the world will
quadruple to approximately 81 million people. A major stumbling block
to the development of effective therapies is the absence of robust
biomarkers that can be used for early detection and monitoring during
clinical trials. There is an obvious need for a diagnostic tool that
can properly identify patients with Alzheimer’s disease in order for
current therapeutics to be effective, and for enrolment into clinical
trials designed to target these biomarker proteins.

About Amorfix

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(TM), 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(TM) and
AMFIA(TM), an ultra-sensitive dual-bead immunoassay. Use of these
technologies has generated a cerebrospinal fluid (CSF) screening test
for both Alzheimer’s disease (AD) and mild cognitive impairment (MCI),
and 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.

SOURCE Amorfix Life Sciences Ltd.


Source: PR Newswire



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