Amorfix Completes Optimization of Alzheimer's Disease Diagnostic and Seeks Strategic Partner for Development and Commercialization of the Assay

TSX: AMF

TORONTO, April 8, 2015 /CNW/ - Amorfix Life Sciences Ltd., a biotechnology company focused on diagnostics and therapeutics for misfolded protein diseases, in particular neurodegenerative diseases, today announced that it has completed the optimization of the EP-AD Alzheimer's disease diagnostic and will seek a strategic partner for further development and commercialization of the assay. 

"We believe our assay to be the 'best in class' diagnostic that can accurately identify patients with early-stage disease, said Dr. Robert Gundel, Amorfix President and CEO.  "In addition, our test has the unique capability to accurately measure levels of aggregated Ab 40 and Ab 42 separately which will be an important tool for continued scientific investigations into the pathogenesis of Alzheimer's disease as well as a means of evaluating the mechanism of action of experimental therapeutics for treatment of this devastating disease." 

The Company entered into a research agreement with a global pharmaceutical company in January 2014 to further refine and optimize the Alzheimer's disease assay.  This work has now been completed resulting in a significant  improvement in the sensitivity of 10 and 30 fold increase  for measurements of Ab 40 and Ab 42, respectively, compared to the previous assay test specifications.  In addition, as part of this collaboration, studies were designed to improve the ability to accurately and separately measure these two important oligomer species.  The research collaboration officially ended March 5, 2015.  The Company is seeking a partner to finalize development and commercialization of the assay. 

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% of cases. As the population around the world ages, the incidence of Alzheimer's disease is predicted to increase significantly. Alzheimer's disease progresses through three defined phases: a stage characterized by amyloid (oligomeric Ab) build-up in the brain without any symptoms of the disease, MCI predominantly affecting memory function, and full-blown Alzheimer's disease. However, loss of memory is very common in normal aging, and does not necessarily indicate Alzheimer's disease. The predominant theory is that a build up of plaques in the brain caused by the clumping and accumulation of Ab leads to neuronal cell death and the onset of Alzheimer's disease symptoms.  The Company has developed a diagnostic that can identify patients with MCI who are destine to develop Alzheimer's disease with 95% sensitivity by measuring the levels of aggregated Ab42 and aggregated Ab40 in patient cerebrospinal fluid (CSF). The ability to separately measure Ab42 and Ab40 is unique to the Amorfix EP-AD diagnostic and allows a greater understanding of the role of aggregated Ab proteins in Alzheimer's disease. 

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 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.

Dr. Robert Gundel, President and Chief Executive Officer, Amorfix Life Sciences Ltd., Tel: [phone], Fax: [phone], [email protected]; Warren Whitehead, Chief Financial Officer, Amorfix Life Sciences Ltd., Tel: [phone], Fax: [phone], [email protected]