Amorfix provides update on ALS diagnostic program

TSX: AMF

TORONTO, Jan. 22, 2013 /CNW/ - Amorfix Life Sciences Ltd. announced that it has completed initial steps in the generation of a blood test for the diagnosis of ALS. Using a proprietary antibody in a simple ELISA assay, the Company is able to detect and measure misfolded superoxide dismutase 1 (SOD1) added into human plasma. Misfolded SOD1 is thought to have an important role in the pathogenesis of both familial and sporadic ALS.

The Company initiated this project based on results from a ground breaking scientific study conducted by Amorfix Chief Scientific Officer Dr. Neil Cashman and colleagues at UBC demonstrating that misfolded SOD1 is present in the blood of ALS patients. The initial scientific discovery was achieved using a technique that is not amenable for use as a screening test, but clearly established the proof of concept for the presence of misfolded SOD1 in the blood of ALS patients. The Company has now taken important first steps towards developing a test that can be easily used by clinicians to rule in or out a diagnosis of ALS.

There is a high unmet medical need for such a test. At the present time, clinicians must rely on a combination of clinical findings and indirect testing to confirm a diagnosis of ALS, as there is no diagnostic test or biomarker at their disposal. The Company believes that the availability of a reliable blood test would represent an important advancement in the management of this devastating disease, allowing clinicians to diagnose the disease earlier and provide better treatment. The projected market for such a diagnostic test is approximately $250M. 

"We are fully exploiting our dominant intellectual property position for misfolded SOD1" said Dr. Robert Gundel, Amorfix President and Chief Executive Officer. "We are using our proprietary antibodies for the development of therapeutic antibodies, through a license agreement with Biogen-Idec, for the development of therapeutic vaccines, through a license agreement with PREVENT, and for the development of a blood test for the early diagnosis and treatment of ALS. The recent data for the ALS blood test represent a significant advancement in the development of a valuable asset for the company."

About ALS

ALS is a common neuromuscular disease, affecting an estimated 120,000 people of all races and ethnic backgrounds worldwide. According to the ALS Association, more than 5,600 people in the U.S. are diagnosed with ALS annually and an estimated 30,000 Americans have ALS at any given time.

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.
Tel: [phone]
Fax: [phone]
[email protected]

Janet Clennett
Acting Chief Financial Officer
Amorfix Life Sciences Ltd.
Tel: [phone]
Fax: [phone]
[email protected]