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Amorfix Is First Company In World To Show Preclinical Efficacy Using Monoclonal Antibodies Targeting Misfolded Regions Of Disease-Causing Proteins

Mon. October 20, 2008; Posted: 07:00 AM
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TORONTO, Oct. 20, 2008 (Canada NewsWire via COMTEX) -- AMF | Quote | Chart | News | PowerRating -- - Amorfix Also Achieves Second Milestone Under Biogen Idec Agreement -

TSX: AMF

TORONTO, Oct. 20 /CNW/ - Amorfix Life Sciences, a company focused on treatments and diagnostics for brain wasting diseases, announced today that its Disease Specific Epitope (DSE) monoclonal antibody treatments demonstrated statistically significant improvement in survival over controls in a mouse model of Amyotrophic Lateral Sclerosis (ALS).

"The potential for Amorfix's novel DSE approach to treating misfolded protein diseases has now taken a huge leap forward with these results," said Dr. Neil Cashman, Chief Scientific Officer of Amorfix. "There are no effective treatments to arrest ALS progression and we believed a new approach was needed. Amorfix's preclinical results give us new hope that we are on the right track to combating this devastating disease."

With these results, Amorfix has achieved the second milestone under the 2006 research, investment and option agreement with Biogen Idec (Nasdaq:BIIB), by demonstrating effectiveness with the antibody treatments. Amorfix achieved the first milestone in July 2007 with the development of monoclonal antibodies that specifically recognize regions on the misfolded superoxide dismutase-1 (SOD1) protein that is widely believed to cause the toxic effects on neurons.

Biogen Idec has an option to license the Amorfix technology for ALS and would be responsible for completing preclinical and clinical development, regulatory approvals, manufacturing and commercialization. If the option is exercised, Amorfix will receive an upfront payment and potential milestone payments in excess of US$25 million under the license agreement. Amorfix will also receive royalties on commercial product sales. With the achievement of this second milestone, Biogen Idec must invest a further US$150,000 in Amorfix to maintain its rights to license the antibodies for use in ALS.

"Our company was founded on a belief that antibodies could be used to both diagnose and treat diseases where misfolded proteins were present and it is a major validation to show DSE monoclonal antibodies are therapeutic in preclinical models of ALS," said Dr. George Adams, Chief Executive Officer of Amorfix. "We have initiated our preclinical program for the treatment of Alzheimer's disease using the same DSE approach and are considering other diseases where we can apply our technology and expertise."

One in a thousand people are afflicted with ALS, which belongs to a family of fatal neurodegenerative diseases, which includes Alzheimer's and Parkinson's diseases. These diseases have aggregated misfolded proteins which are thought to be a major pathway in the progressive killing of nerve cells. In ALS, motor neurons are attacked causing neurodegeneration of the brain and spinal chord. Amorfix's therapeutic approach is based on the premise that the misfolding and aggregation of SOD1 is a principal agent in the death of motor neurons in all types of ALS disease. Amorfix believes its antibodies recognize and neutralize the misfolded SOD1 prior to aggregation and thereby inhibit the progression of the disease, while leaving normally-folded SOD1 to perform its anti-oxidant protective function in the body.

About Amorfix

Amorfix Life Sciences Ltd. (TSX:AMF) is a theranostics company developing therapeutic products and diagnostic devices targeting brain-wasting diseases including ALS, Alzheimer's Disease, Parkinson's Disease and variant Creutzfeldt-Jakob Disease (vCJD). Amorfix's proprietary Epitope Protection(TM) (EP) technology enables it to specifically identify very low levels of aggregated misfolded proteins (AMP) in a sample of normal protein. Aggregated misfolded proteins are a common element of many brain wasting diseases and the ability to identify AMPs and understand their structure and mechanism of folding are the first steps to developing new treatments for these devastating diseases. Amorfix's lead programs are a diagnostic blood screening test for vCJD and a therapy for ALS.

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.

%SEDAR: 00022789E

SOURCE: Amorfix Life Sciences Ltd.

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

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