TSX: AMF
"We have created a broad development pipeline of 3 diagnostic products and 3 therapeutic products and have demonstrated our leadership in the misfolded protein space," said
Development and Corporate Highlights vCJD ---- - In December 2009, the Company announced that NIBSC provided three plasma samples from three different vCJD patients which the Company tested using the first generation of the EP-vCJD(TM) test. The samples tested negative and the UK authorities have concluded that the first generation test is not sufficiently sensitive to detect infected human blood samples. The Company continues development activities to improve the sensitivity of its EP-vCJD(TM) blood screening test and the 2nd generation test 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 may provide a third generation blood test with even greater sensitivity. NIBSC has agreed to enter an improved EP-vCJD(TM) test into the program to test clinical-stage vCJD samples when validated using infected animal samples and shown to meet the NIBSC requirement for specificity. ALS/Alzheimer's Disease (AD) --------------------------- - In December 2009, the Company announced that it is conducting pilot studies with its A4 assay 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 reduce amyloid formation in animal models of AD. - In December 2009, the Company recorded its first revenues for its A4 AD assay. The Company is aggressively marketing this service to AD researchers worldwide. - The SOD1 antibody and vaccine preclinical treatment studies in AD continue on schedule with the first series of experiments expected to be complete in the first quarter of calendar 2010. - The Company is engaged in discussions with partners for its antibodies and vaccines to misfolded SOD1 for use in ALS disease. Cancer ------ - The Company has selected four proteins for study and using ProMIS(TM) has determined a total of 39 Disease Specific Epitopes (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. 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. - Amorfix has completed the development of a prototype test for early detection of hepatocellular carcinoma or primary liver cancer and will now start testing clinical samples to determine sensitivity and specificity.
Financial Results
For the three months ended
The Company recorded its first service revenue from the A4 test and also recorded revenue related to a third party research agreement totalling
Research and development expenditures for the three months ended
General and administration costs for the three months ended
Cash burn (cash used in operating activities) for the three months ended
As at
As at
Outlook
The Company's fiscal 2010 diagnostic priorities are to: - increasing the sensitivity of the EP-vCJD(TM) assay in second and third generation versions, while maintaining acceptable specificity; - obtaining vCJD patient samples, samples from high-risk groups, and infected animal samples; - form collaborations to further validate the benefits of the A4 amyloid assay and to grow the service business providing this assay for testing preclinical samples; and - complete development of the screening test for liver cancer in collaboration with BioMosaics and Sunnybrook Research Institute. The company's 2010 therapeutic priorities are to: - advance the ALS vaccine and antibody DSE programs through partnerships; - complete proof-of-concept preclinical studies for Alzheimer's Disease targeting misfolded SOD1; - leverage the company's core capability of identifying misfolded protein targets using our ProMIS(TM) technology, generate antibodies, and initiate development and/or partnerships with novel therapeutic and diagnostic antibodies.
Additional information about the Company, including the MD&A and financial results may be found on SEDAR at www.sedar.com.
About Amorfix
Amorfix Life Sciences Ltd. (TSX:AMF) is a theranostics company developing therapeutic products and diagnostic devices targeting misfolded protein 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 diagnosis of vCJD and 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.
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.
%SEDAR: 00022789E
For further information: Dr. George Adams, President & Chief Executive Officer, Amorfix Life Sciences Ltd., Tel: (416) 847-6959, Fax: (416) 847-6899, [email protected]; James Parsons, Chief Financial Officer, Amorfix Life Sciences Ltd., Tel: (416) 847-6929, Fax: (416) 847-6899, [email protected]
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