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Amorfix Life Sciences Ltd. Expands Diagnostic and Therapeutic Focus to Include Misfolded Protein Diseases Including Cancer

4/20/2009 6:40:46 AM

TORONTO, April 20 /CNW/ - Amorfix Life Sciences (TSX:AMF - News), a company focused on treatments and diagnostics for misfolded protein diseases wishes to outline its six (6) product development programs.

"Our vCJD test is being used in feasibility testing by the national blood transfusion service in France and our antibodies and vaccines for ALS have shown prolongation of life in preclinical studies," said Dr. George Adams, CEO of Amorfix. "With this success, it is time to expand our focus and apply our expertise to more misfolded protein diseases."


Blood test for variant Creutzfeldt-Jakob Disease (vCJD): Based upon its patent pending Epitope Protection technology, Amorfix has developed the most sensitive (100% at 1:1,000,000 dilution of brain homogenates spiked into blood samples) and specific (99.9% based on 10,000 normal samples) test (EP-vCJD(TM)) for vCJD prions ever reported. This exceptional performance of the vCJD test has been verified in collaboration with the National Institute for Biological Standards and Control (NIBSC) in the United Kingdom. Further, the blood transfusion service in France is conducting large-scale testing of blood donations to demonstrate the feasibility of routine testing of blood donations for vCJD in Strasbourg and is enabling a second blood transfusion centre in Montpellier. The results from the Strasburg study will be presented at le Congrès 2009 de la Société Française de Transfusion Sanguine in Strasbourg, June 22-25, 2009.

Amorfix is the leading company in the NIBSC process to further validate the EP-vCJD(TM) by testing rare blood samples from vCJD patients to demonstrate the test can detect human blood prions, as well as human brain and spleen prions. Amorfix has been informed that it will be required to test additional prion-infected animal samples, supplied by NIBSC, prior to being granted access to the vCJD blood samples. Amorfix expects to carry out this additional animal testing in the next few weeks at the NIBSC laboratories. Testing the human patient samples may also be a requirement prior to initiating prevalence testing in the UK. On March 18, 2009, the UK National Health Service published a tender to supply blood test kits for a 10,000 sample assessment panel, a 50,000 sample prevalence study, and unlimited kits for routine testing.

Tissue test for Abeta amyloid in Alzheimer's disease (A4): The company received an IRAP grant to develop a test for Alzheimer's disease. To date, the test has been shown to detect Abeta amyloid in human and animal brain tissue. The validation results for the A4 test will be presented at the International Congress on AD this summer and the company will be offering the A4 test as a service to drug discovery companies and academic researchers working to discover new treatments for AD. Since the A4 test is able to detect amyloid build up in animals much earlier than conventional methods, the A4 test will accelerate the development and evaluation of new treatments for AD.

Blood test for sheep scrapie: The company has developed a prototype blood test for scrapie in live sheep and shown it can detect infected lambs. An analysis of the market opportunity suggests scrapie must be recognized as a public health issue (that is newer strains of scrapie are shown to cause vCJD) before it would be widely used to eliminate scrapie-infected sheep. Accordingly, the company has suspended further development until testing of the newer strains of scrapie has been reported.

New blood tests for misfolded proteins: The excellent results with the vCJD testing platform have given the company an opportunity to expand its menu of diagnostic tests. Amorfix has identified companies and academic groups with established biomarkers that can be developed into screening tests. Announcements will be made as each project is initiated.


ALS (Lou Gehrig's disease): The company has shown its antibodies and vaccines to misfolded SOD1 can prolong life in an animal model of ALS. It is seeking to partner with a biotechnology company to humanize the antibodies and initiate clinical trials. A special Committee of the Board of Directors has been formed to oversee the process. Because vaccines have different development timelines and require special expertise compared to the antibodies, Amorfix is seeking other partners to develop the vaccines. It is hoped these partnerships will be established before the end of the calendar year.

Alzheimer's disease: The company has identified misfolded SOD1 co-located with the Abeta amyloid in the brains of people with AD. Since misfolded SOD1 is known to be toxic for nerve cells, the company has initiated preclinical animal studies with its antibodies and vaccines to determine their therapeutic potential for AD. A CIHR-POP II grant was awarded to conduct these studies which should have first results by the end of the calendar year.

New misfolded protein therapeutics: The company is the world leader in demonstrating antibodies and vaccines to misfolded proteins are therapeutic in neurodegenerative diseases. The process of identifying novel disease-specific epitopes (DSE) on misfolded proteins is extremely complex and represents a unique core expertise of the company and its CSO. The company plans to target proteins which may be misfolded in diseases where cells are under stress and more likely to produce misfolded proteins like cancer. Once a protein has been identified, antibodies and vaccines can be developed as previously shown. The company is establishing strategic alliances to expand its capabilities to develop immunotherapeutics to numerous proteins. These alliances will be announced as they are formed.

About Amorfix

Amorfix Life Sciences Ltd. (TSX:AMF - News) is a theranostics company developing therapeutic products and diagnostic devices targeting misfolded diseases including neurodegenerative diseases and cancer. It has specific programs in vCJD, ALS and Alzheimer's Disease. Amorfix's proprietary Epitope Protection(TM) (EP) technology enables it to specifically identify very low levels of aggregated misfolded proteins (AMP) in a sample containing normal protein. Aggregated misfolded proteins are a common element of many brain wasting diseases and cancer. Amorfix has shown antibodies and vaccines to misfolded proteins are therapeutic in preclinical animal models. 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.

For further information

Dr. George Adams, President & Chief Executive Officer, Amorfix Life Sciences Ltd., Tel: (416) 847-6959, Fax: (416) 847-6899, James Parsons, Chief Financial Officer, Amorfix Life Sciences Ltd., Tel: (416) 847-6929, Fax: (416) 847-6899,

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