Amorfix Begins Offering EP-AD Diagnostic for Alzheimer's Disease Drug Development

Amorfix Begins Offering EP-AD Diagnostic for Alzheimer's Disease Drug 
TORONTO, Nov. 21, 2012 /CNW/ - In response to interest from the drug 
development industry, Amorfix Life Sciences Ltd. announced today that it is 
offering the EP-AD assay service to customers and that a number of 
pharmaceutical companies are currently evaluating the test in several pilot 
Amorfix previously announced that the EP-AD test has shown a significant 
increase in aggregated Abeta levels in CSF samples from AD patients and 
patients with mild cognitive impairment (MCI) compared to age-matched control 
subjects. More recently, the Company announced that it has found 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. In a study conducted by the Company, the ED-AD CSF test 
was more sensitive at identifying individuals with MCI (94% sensitivity) than 
current biomarkers (monomeric Abeta 42 and phospho-tau). The Amorfix 
diagnostic offers several distinct advantages over the other tests. It 
measures small aggregates of Abeta (called oligomers) which are thought to be 
responsible for the major part of Abeta toxicity, and are regarded as the most 
relevant molecule in disease pathogenesis. In addition, the ED-AD CSF test 
can identify early-stage patients before they progress into frank AD. 
Alzheimer's disease progresses through three defined phases: a stage 
characterized by amyloid buildup in the brain without any symptoms of the 
disease, MCI predominantly affecting memory function, and full-blown 
Alzheimer's disease. Loss of memory is common in normal aging. Diagnostic 
tools are needed to differentiate between mere age related loss of memory and 
early onset of AD. 
Dr. Robert Gundel, President and CEO of Amorfix said, "We are very excited to 
launch this new service that will provide greatly needed information on the 
identification of early-stage AD and assist in the development of novel 
compounds for the treatment of this devastating disease. The results of 
recent AD trials have indicated that the best chance of slowing down the 
disease process is to treat patients with early-stage disease. The EP-AD 
assay has excellent sensitivity for early-stage diagnosis and enrolment into 
clinical trials. In addition, this assay has the potential for use as a 
biomarker to track the effectiveness of treatment to reduce or prevent plaque 
formation over time". 
Amorfix is currently providing the diagnostic assay technology to a number of 
pharmaceutical and biotech companies on a fee-for-service basis. The data 
generated by these studies will expand the database and experience with the 
assay and help to validate its use as a general diagnostic for AD. 
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 
clinical monitoring during clinical trials. There is an obvious need for a 
diagnostic tool that can properly identify patients with AD in order for 
current therapeutics to be effective, and for enrollment 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™, 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 
a cerebrospinal fluid (CSF) screening test for Alzheimer's disease, 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 
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update or revise any forward-looking statements, whether as a result of new 
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ProMIS™, Epitope Protection™ and AMFIA™ are trademarks of Amorfix Life 
Sciences Ltd.  
Dr. Robert Gundel President and Chief Executive Officer Amorfix Life Sciences 
Ltd. Tel: (416) 847-6957 Fax: (416) 847-6899 
Janet Clennett Chief Financial Officer Amorfix Life Sciences Ltd. Tel: (416) 
847-6926 Fax: (416) 847-6899 
SOURCE: Amorfix Life Sciences Ltd. 
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