TORONTO , Dec. 29 /CNW/ - Amorfix Life Sciences (TSX:AMF), a company focused on treatments and diagnostics for misfolded protein diseases provides a corporate update on its six (6) product development programs.
"We continue to advance 3 diagnostic projects and 3 therapeutic projects while limiting our cash consumption by accessing government grants for research and personnel," said Dr. George Adams , CEO of Amorfix. "We have first sales for our Alzheimer's-related amyloid testing service and our monoclonal antibodies which are distributed through Cedarlane Laboratories."
Blood Test for variant Creutzfeldt-Jakob Disease (vCJD): The Company continues in the UK National Institute for Biological Standards and Control (NIBSC) process to obtain and test retained blood samples from clinical-stage patients who have died and been verified to have vCJD. The NIBSC provided three plasma samples from three different patients which the Company tested using the first generation of the EP-vCJD(TM) test. The samples tested negative and NIBSC has concluded that the first generation test is not sufficiently sensitive to detect infected human blood samples.
"As the first company ever to be given access to human blood from vCJD patients, we understood the level of prions in patients' blood was unknown and recognized that a higher sensitivity assay may be required," said Dr. Neil Cashman , CSO for Amorfix.
The Company has continued development activities to improve the sensitivity of its EP-vCJD(TM) blood screening test and in a second-generation test it has already attained a five-fold improvement in the level of sensitivity so it is now able to detect a 1:5,000,000 dilution of vCJD infected brain spiked into blood samples. This level of sensitivity is fifty times the minimum analytical sensitivity required by the UK authorities to continue evaluation of the assay.
A recent modification shows promise of providing a third generation blood test with a 1:10,000,000 sensitivity. This, if confirmed, would be twice as sensitive as the second generation EP-vCJD(TM) blood test and ten times the sensitivity of the first generation blood test used on the three samples in the initial phase of the NIBSC process.
The NIBSC has agreed to enter the improved EP-vCJD(TM) test(s) into the program to test clinical-stage vCJD samples when validated using infected animal samples and shown to meet the NIBSC requirement for specificity.
In addition, the Company is attempting to obtain additional vCJD samples from other countries, and also from individuals with the disease.
Amorfix Test for Abeta Amyloid in Alzheimer's Disease (A(4)): At the International Conference on Alzheimer's Disease (ICAD2009), Amorfix launched its Alzheimer's-related Abeta amyloid test for tissue samples, A(4) assay, which can detect Abeta amyloid accumulation in the brain of animal models of AD several months before conventional procedures. The Company is conducting pilot studies with several pharmaceutical companies engaged in developing new treatments for AD and one company has publicly announced their results verifying their novel drug's ability to reduced amyloid formation in animal models of AD. The Company has recorded its first sales for this service and expects additional customers to order the test as the pilot series are completed and the test is integrated into their standard practice to accelerate the development and evaluation of new treatments for Alzheimer's disease. The Company estimates the market for this service to be 50,000 tests per year.
In September, the Company received a second grant from the National Research Council Canada Industrial Research Assistance Program (NRC-IRAP) of $50,000 to continue development of an assay to measure Alzheimer's-related amyloid in blood. The assay has increased sensitivity and we are ready to determine if it can detect amyloid in AD blood. The Company will first test blood from animal models which is readily available. There continues to be a need for a simple screening test for AD to identify patients, conduct clinical trials of new treatments, and to monitor disease progression.
Test for Liver Cancer: Amorfix has completed the development of a prototype test for early detection of hepatocellular carcinoma (HCC) or primary liver cancer and will now start testing clinical samples to determine sensitivity and specificity. A key issue is the differentiation between cirrhosis, hepatitis and HCC. This is a joint project with BioMosaics Inc. and is funded by an "Intellectual Property Development and Commercialization Program" investment of $280,000 from the Ontario Institute for Cancer Research to the Sunnybrook Research Institute.
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. Amorfix has strong interest from potential partners for both the antibodies and vaccines and it is hoped these discussions will lead to definitive agreements in the first half of 2010.
Alzheimer's Disease (AD): 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 support these studies and the first results should be available by the end of the first quarter 2010.
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. The Company has licensed the exclusive rights to the ProMIS(TM) target identification technology and has begun to analyze selected proteins from the 57,000 protein structures currently available in public databases.
The Company has selected four proteins for study and using ProMIS(TM) has determined a total of 39 DSE sites on these four protein targets. Recent studies with a monoclonal antibody to an undisclosed DSE site on one of the four selected proteins confirmed that the misfolded protein is present on lymphomas and melanoma cells but not on normal cells of the same type. The antibody targets a specific DSE region of the misfolded protein that is not present on the normally folded protein. This new finding indicates that the antibody has potential to be developed for both diagnostic uses and therapeutic treatments for several cancers.
"This first evidence of a misfolded protein on cancer cells validates our novel approach of targeting misfolded proteins," said Dr. George Adams , CEO of Amorfix. "The Company has a commanding lead in the field of identifying misfolded proteins through its ProMIS(TM) discovery platform."
"Our next goal is to demonstrate the efficacy of the DSE antibody in appropriate animal models for key cancer indications," said Dr. Neil Cashman .
Amorfix is also exploring partnerships with other companies to accelerate their programs for misfolded proteins.
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, variant Creutzfeldt-Jakob Disease (vCJD) and Cancer. 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 utilizes its computational discovery platform, ProMIS(TM), to predict novel Disease Specific Epitopes ("DSE") on the molecular surface of misfolded proteins. ProMIS(TM) is an "in silico" rational selection approach that can be applied to any protein where the normal folding structure is at least partially known. Amorfix's lead therapeutic programs include antibodies and vaccines to DSEs in ALS, Alzheimer's disease and Cancer. The Company's diagnostic programs include a blood screening test for vCJD and the A(4) test, an ultrasensitive method for the detection of aggregated Beta-Amyloid in brain tissue of animal models of Alzheimer's disease, months prior to plaque formation.
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: For further information: Dr. George Adams, President & Chief Executive Officer, Amorfix Life Sciences Ltd., Tel: (416) 847-6959, Fax: (416) 847-6899, firstname.lastname@example.org; James Parsons, Chief Financial Officer, Amorfix Life Sciences Ltd., Tel: (416) 847-6929, Fax: (416) 847-6899, email@example.com