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December 23, 2005
Amorfix achieves first technical milestone and begins assay validation with human vCJD blood samples
"TORONTO (22 Dec. 2005)- Amorfix (AMF) Life Sciences announced today that it has successfully completed its first research and development milestone to develop a test for the detection of prions in blood from laboratory animals. The company is now ready to verify that its EP-vCJD(TM) assay can be an ante-mortem blood test for the human form of "mad cow disease" known as variant Creutzfeldt-Jakob Disease or vCJD. A test is urgently needed to screen human blood for transfusion as it is now known that vCJD is transmitted by blood transfusions.
Dr. George Adams, Amorfix's CEO said, "I am very pleased to report that we have reached this milestone. It marks a turning point for the company as we move from experiments in model systems to the detection of vCJD prions in human blood".
As a next step, the assay will be optimized for human samples. The National vCJD Surveillance Unit (NCJDSU) and the British National Institute for Biological Standards and Controls (NIBSC) have recently issued a series of rigorous assessments that vCJD blood diagnostic tests must pass through in order to be accepted. Amorfix has been approved to start this validation process and will be given access to human CJD samples. Dr. Neil Cashman, Amorfix's CSO said, "We have learned all we can from animal blood and it is time to begin testing human blood for infectious prions to secure the blood transfusion systems worldwide."
The company has upgraded its laboratory and has received regulatory approval from the Public Health Agency of Canada to work with vCJD material. This is the first commercial laboratory in Canada approved to work with tissue and blood samples containing vCJD prions.
The NCJDSU has blood and tissue samples from approximately 150 people who have been diagnosed with vCJD and subsequently died. The process to access these samples and validate a blood test for vCJD has recently been revised and now has 3 steps which culminate in a test panel containing peripheral blood or plasma samples from patients with variant CJD, patients with sporadic CJD, patients with other neurological conditions and "normal controls" from blood donors. At the completion of each step the British Department of Health, Tissue Management Group will review the data and approve the continuation of the process and the release of the next series of samples. This tissue bank is the only way to verify vCJD can be detected in blood. Since no company, academic or research group has completed this validation process before, it is uncertain exactly how long it will take. The company expects to complete the process in 3 to 6 months.
About Amorfix: Amorfix is an emerging theranostics company focused on the diagnosis and treatment of neurodegenerative diseases, where aggregated misfolded proteins (AMPs) are prevalent. These include aggregated misfolded prion protein which makes up "prions," the infectious agents of the Transmissible Spongiform Encephalopathies (TSE), such as Bovine Spongiform Encephalopathy (BSE or "mad cow disease") and the human form, variant Creutzfeldt-Jakob Disease (vCJD), as well as degenerative diseases such as Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS) and Parkinson's Disease (PD). Amorfix was formed to commercialize epitope protection (EP) technologies and related discoveries to become the world leader on AMP diseases. The company will use this new knowledge to develop diagnostic kits, therapeutics and prophylactics for AMP diseases.
The TSX Venture Exchange 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. Actual future results may differ materially from those contemplated. The risks, uncertainties and other factors that could influence the actual results are described in documents filed with regulatory authorities.
For further information: visit the website at www.amorfix.com or contact: Dr. George Adams, President and CEO, Amorfix Life Sciences Ltd., (416) 557-4647, george.adams@amorfix.com; James Parsons, CFO, Amorfix Life Sciences Ltd., (416) 705-5686, james.parsons@amorfix.com
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Dr. George Adams, Amorfix's CEO said, "I am very pleased to report that we have reached this milestone. It marks a turning point for the company as we move from experiments in model systems to the detection of vCJD prions in human blood".
As a next step, the assay will be optimized for human samples. The National vCJD Surveillance Unit (NCJDSU) and the British National Institute for Biological Standards and Controls (NIBSC) have recently issued a series of rigorous assessments that vCJD blood diagnostic tests must pass through in order to be accepted. Amorfix has been approved to start this validation process and will be given access to human CJD samples. Dr. Neil Cashman, Amorfix's CSO said, "We have learned all we can from animal blood and it is time to begin testing human blood for infectious prions to secure the blood transfusion systems worldwide."
The company has upgraded its laboratory and has received regulatory approval from the Public Health Agency of Canada to work with vCJD material. This is the first commercial laboratory in Canada approved to work with tissue and blood samples containing vCJD prions.
The NCJDSU has blood and tissue samples from approximately 150 people who have been diagnosed with vCJD and subsequently died. The process to access these samples and validate a blood test for vCJD has recently been revised and now has 3 steps which culminate in a test panel containing peripheral blood or plasma samples from patients with variant CJD, patients with sporadic CJD, patients with other neurological conditions and "normal controls" from blood donors. At the completion of each step the British Department of Health, Tissue Management Group will review the data and approve the continuation of the process and the release of the next series of samples. This tissue bank is the only way to verify vCJD can be detected in blood. Since no company, academic or research group has completed this validation process before, it is uncertain exactly how long it will take. The company expects to complete the process in 3 to 6 months.
About Amorfix: Amorfix is an emerging theranostics company focused on the diagnosis and treatment of neurodegenerative diseases, where aggregated misfolded proteins (AMPs) are prevalent. These include aggregated misfolded prion protein which makes up "prions," the infectious agents of the Transmissible Spongiform Encephalopathies (TSE), such as Bovine Spongiform Encephalopathy (BSE or "mad cow disease") and the human form, variant Creutzfeldt-Jakob Disease (vCJD), as well as degenerative diseases such as Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS) and Parkinson's Disease (PD). Amorfix was formed to commercialize epitope protection (EP) technologies and related discoveries to become the world leader on AMP diseases. The company will use this new knowledge to develop diagnostic kits, therapeutics and prophylactics for AMP diseases.
The TSX Venture Exchange 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. Actual future results may differ materially from those contemplated. The risks, uncertainties and other factors that could influence the actual results are described in documents filed with regulatory authorities.
For further information: visit the website at www.amorfix.com or contact: Dr. George Adams, President and CEO, Amorfix Life Sciences Ltd., (416) 557-4647, george.adams@amorfix.com; James Parsons, CFO, Amorfix Life Sciences Ltd., (416) 705-5686, james.parsons@amorfix.com
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posted by Dr. Koudinov @ 23.12.05
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