TORONTO, Oct. 27 /CNW/ - Amorfix Life Sciences, a company focused on treatments and diagnostics for misfolded protein diseases, announced today it has detected prions in blood from non-human primates that were orally-infected with BSE and developed a primate version of vCJD.
"Amorfix was able to obtain only a limited number of these very rare primate samples. Considering the small number of samples tested, these results are promising," said Dr. Neil Cashman, Chief Scientific Officer of Amorfix. "Given these results and the similarity of this primate model to humans, it is important to now test human vCJD blood samples."
Blood samples were obtained from a European-sponsored vCJD primate study. Amorfix previously reported detecting endogenous prions in blood from sheep with prion disease (scrapie), but biochemical detection of vCJD endogenous prions in cynomolgus primates has never before been reported. It is known that the blood from primates with vCJD is infectious as transfusion of the blood resulted in transmission of the disease. The Company made minor modifications to its EP-vCJD(TM) blood screening assay in order to test the primate samples.
The results of the study demonstrated a trend in the measure of prion detection. The highest signals were detected in blood from two non-human primates, one of which was clinically symptomatic and one which was presymptomatic (See Figure 1 in press release on Amorfix web site at www.amorfix.com). Blood samples from two other pre-symptomatic animals were found to have intermediate results. Each sample was tested on two separate days in blinded panels that included control plasma samples. These rare primate samples were the only ones available at this time from the European study which is ongoing. The Company is seeking additional samples to determine the variability in clinical and preclinical levels in primates infected with BSE that come down with the primate equivalent of vCJD.
The Company is continuing in the UK National Institute for Biological Standards and Control process to access blood samples collected from vCJD patients and expects to test these samples in the next few months. The UK Government has calculated the required sensitivity to detect an infectious dose of prions in human blood is 1:100,000 of homogenized brain diluted in blood plasma. The Amorfix EP-vCJD(TM) test has been verified to detect prions at a 1:1,000,000 dilution of brain homogenates and hence is ten times more sensitive than required based on the UK expectation for prions in blood. The concentration of endogenous prions in vCJD patient blood is unknown.
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 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.
This press 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.
SOURCE Amorfix Life Sciences Ltd.
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; Dr. Neil Cashman, Chief Scientific Officer, Amorfix Life Sciences Ltd., Tel: (778) 994-2626, Fax: (416) 847-6899, email@example.com