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Amorfix Life Sciences Announces World’s First Detection of Aggregated Beta-Amyloid in Blood Using the Alzheimer’s Diagnostic A4 Assay

TORONTO, ON –  Amorfix Life Sciences, a company focused on treatments and diagnostics for misfolded protein diseases such as Alzheimer’s disease (AD), announced today the detection of the AD-associated aggregated Beta-amyloid (ABeta), the hallmark of AD, in the blood from the most-frequently-used animal model of AD.  The assay detects both oligomeric and fibrillar aggregates of ABeta, which are generally considered to be the toxic forms and major contributors to brain dysfunction in AD.

“This milestone achievement represents the first time that aggregated ABeta has been measured in blood plasma from any animal model. This discovery provides an important new tool for understanding AD and will significantly accelerate the evaluation of novel treatments for the disease,” said Dr. Neil Cashman, Chief Scientific Officer of Amorfix. “Our detection of aggregated ABeta in blood plasma demonstrates the superior sensitivity and specificity of the A4 test and its utility for use with tissues and biofluids”.

Dr. George Adams, Chief Executive Officer of Amorfix added, “We already have a number of prestigious academic institutions and pharmaceutical companies utilizing our commercial A4 test for ABeta in brain, so the added capability of detecting ABeta in blood plasma will further entrench Amorfix as an emerging leader in preclinical AD diagnostics.”

The quantitative measurement of aggregated ABeta in blood plasma was obtained using the Amorfix A4 on samples from Tg2576 transgenic mice as early as 3 months of age. The Tg2576 mouse is the most commonly used transgenic model for preclinical evaluation of potential AD therapeutics. The aggregated peptide was detected in the blood from transgenic mice, but not in blood from non-transgenic age-matched control mice. Amorfix developed the A4 as an ultra-sensitive method for early detection of aggregated ΑBeta. The A4 assay will allow scientists to monitor levels of aggregated Abeta in the blood of individual AD mice as they age and to detect the impact of treatments with novel AD medications.

The company is continuing to develop an AD blood screening test for humans for early diagnosis and monitoring of disease progression.  There are over 400 million people in the world who would be checked regularly for AD if a screening test were available and this number is expected to double in the next 15 years.  Like cancer, people should be screened to determine when AD begins to enable early treatment leading to improved outcomes.  The detection of aggregated ABeta in animal models is encouraging as it suggests that aggregated ABeta may be present in the blood of AD patients.

The company continues to build its A4 testing business with the addition of senior researchers and pharmaceutical companies as customers.  Amorfix is also announcing the expansion of its A4 testing service to include the measurement of aggregated ABeta in blood to complement the existing brain testing services. Please contact Dr. Louise Scrocchi at louise.scrocchi@amorfix.com for further information.

About A4 Assay

The Amorfix A4 assay is an ultrasensitive method for the detection of aggregated ABeta that provides quantitative measurements of aggregates. The A4 can detect aggregates in plasma and tissue of standard animal models of AD several months before conventional microscopic procedures thereby accelerating the preclinical screening of new drugs for AD. The A4 is significantly more sensitive than current methods for detecting total Abeta and can be used in high-throughput applications designed to study the inhibition of amyloid formation.

About Amorfix

Amorfix Life Sciences Ltd. (TSX:AMF) is a theranostics company developing therapeutic products and diagnostic devices targeting misfolded protein diseases including ALS, cancer, Alzheimer’s Disease (AD) and variant Creutzfeldt-Jakob Disease (vCJD). Amorfix utilizes its computational discovery platform, ProMIS™, to predict novel Disease Specific Epitopes (“DSE”) on the molecular surface of misfolded proteins.  Amorfix’s lead therapeutic programs include antibodies and vaccines to DSEs in ALS, AD and cancer.  Amorfix’s proprietary Epitope Protection™ (EP) technology enables it to specifically identify very low levels of aggregated misfolded proteins (AMP) in a normal sample. The Company’s diagnostic programs include an ultrasensitive method for the detection of aggregated β-Amyloid in brain tissue and CSF of animal models of AD, months prior to observable amyloid formation, and a blood screening test for vCJD. For more information about Amorfix, visit www.amorfix.com <http://amorfixlifesciencesltd.cmail2.com/t/y/l/blyiij/jjuyijydk/y> .

Forward-Looking Information

This press 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.

For more information, please contact:

Dr. George Adams

President & Chief Executive Officer

Amorfix Life Sciences Ltd.

Tel: (416) 847-6959

Fax: (416) 847-6899

george.adams@amorfix.com

 

 James Parsons

Chief Financial Officer

Amorfix Life Sciences Ltd.

Tel: (416) 847-6929

Fax: (416) 847-6899

james.parsons@amorfix.com

 

OGI invested in Amorfix Life Sciences through its Pre-commercialization Business Development Fund in 2006 to support the development of a blood test for Alzheimer's disease.  For more information click here