Amorfix Alzheimer's Disease Diagnostic Test Allows Accurate Identification of Early Stages of Alzheimer's Disease

TORONTO, Aug. 15, 2012 /CNW/ - Amorfix Life Sciences Ltd today provided details of the results of its recent study presented at the July 2012 Alzheimer's Association International Conference (AAIC) in Vancouver, which demonstrate that it's EP-AD test is the most accurate biochemical diagnostic test today to identify patients with Mild Cognitive Impairment (MCI) characterizing the early stages of Alzheimer's disease (AD).

"There are more than 35 million people worldwide that have AD for which there is currently no effective treatment" said Amorfix President and CEO Dr. Robert Gundel.  "A significant stumbling block to the development of new therapeutics is the absence of a robust and accurate diagnostic assay to measure biomarkers for early detection of the disease and for monitoring the effectiveness of therapeutic interventions.  We believe that the use of our EP-AD diagnostic test provides a much needed  opportunity for the early detection of the onset of AD. We are now offering it as an important new tool to facilitate clinical development and help bring promising new therapeutics through clinical trials  to the patients".

The Amorfix EP-AD test is an ultra-sensitive assay for the detection of oligomeric Aß (aggregated Aß), a known biomarker for AD, in human cerebrospinal fluid (CSF). Oligomers are small aggregates and the building blocks that are toxic to neurons and eventually form plaques in the brains of AD patients.  The ability to detect and measure them at the early onset of AD symptoms in the form of Mild Cognitive Impairment would provide a therapeutic window to treat patients before irreversible brain damage occurs.  The results from the Company's latest study of almost 200 clinical CSF samples, including samples obtained from normal subjects, patients with MCI, and patients with AD, showed that both the MCI and AD patients have statistically significant higher levels of oligomeric Aß compared with the CSF from normal subjects.  The level of oligomeric Aß in CSF from MCI patients was significantly higher compared to AD patients and form part of the basis for the identification of early-stage disease before frank AD sets in.

The Amorfix study also included measurement of standard AD biomarkers including Aß42, Tau and phospho-Tau.  With a sensitivity of 94% for MCI individuals, the EP-AD test outperformed all other biochemical marker tests, the best having 54% sensitivity.  The combination of EP-AD and Aß42 measurements was the most sensitive for detecting AD (94%), again, considerably higher than Aß42/Tau ratios (82%) which are currently used by many investigators.  All biomarker tests had a specificity of 80%.

"Aggregated Aß is the superior biomarker for the identification, detection and monitoring of MCI individuals and presents an opportunity for researchers to identify early-stage AD patients for enrolment into clinical trials" said Amorfix founder and CSO Dr. Neil Cashman.  "These are the patients who are most likely to benefit from therapeutic intervention as late-stage patients have already experienced neural damage that may be irreversible."

These results firmly position Amorfix as the  leader in the AD diagnostic space since there is no other biochemical test available with comparable sensitivity and specificity.  As several important large clinical trials on AD have recently come to an end, it is clear that the best chance for a successful therapeutic outcome is to identify and enrol early-stage AD patients with MCI symptoms. Apparently, once the neurological damage is done, it is likely not reversible.  The use of the Amorfix EP-AD test will allow researchers to identify and treat patients at a much earlier stage of disease progression thereby improving the overall chance of successfully advancing new therapeutics through clinical trials to the market.

The Company's plan is to offer the EP-AD test to researchers and pharmaceutical companies as a tool to facilitate better clinical trials in early stages of AD by optimizing patient enrolment and enable them to follow the effects of treatment on aggregated Aß, one of the hallmarks of the disease. 

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

(AD) is predicted to increase significantly. Alzheimer's disease progresses through three defined phases: a stage characterized by amyloid (oligomeric Aß) 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 Aß leads to neuronal cell death and the onset of Alzheimer's disease symptoms.

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, unless required by law.

ProMIS™, Epitope Protection™ and AMFIA™ are trademarks of Amorfix Life Sciences Ltd.

SOURCE: Amorfix Life Sciences Ltd.

Dr. Robert Gundel
President and Chief Executive Officer
Amorfix Life Sciences Ltd.
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[email protected]

Janet Clennett
Chief Financial Officer
Amorfix Life Sciences Ltd.
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[email protected]