Amorfix Life Sciences shows early success with biochemical test designed to more accurately test for Alzheimer’s in patients with dementia
Mississauga, Ontario – January 24, 2011 – Canadian researchers have taken the first step towards a major breakthrough in the early detection of Alzheimer’s disease.
Mississauga, Ontario-based Amorfix Life Sciences Ltd. has announced that it has developed a new diagnostic test that is able to measure clumped protein fragments, called aggregated beta amyloid, in human cerebral spinal fluid which may indicate the presence of Alzheimer’s disease and will make it easier to accurately diagnose the disease.
Currently, the only definitive diagnosis for Alzheimer’s is a post-mortem examination of brain tissue to identify the presence of the proteins that lead to plaque formation around neurons in the brain, believed to cause the symptoms of the disease. The Amorfix test is conducted on the cerebral spinal fluid from living patients, representing a significant step forward in early detection and subsequent treatment of the disease.
“Our hope is to one day be able to use this test on patients showing early signs of dementia in order to predict which patients may progress rapidly into the disease and which may not,” said Dr. Robert Gundel, Amorfix president and chief executive officer, noting that the early diagnosis of a disease typically means a better outcome.
“Being able to accurately determine who has the disease will also facilitate new research in the area and will greatly enhance the quality of clinical trials for new treatments being developed,” he said.
Preliminary results suggest that the company’s newly-developed biochemical test can detect the presence of the aggregated beta amyloid in the cerebral spinal fluid which is collected when investigating patients for Alzheimer’s. The next step is to optimize the test for commercialization by comparing hundreds of spinal fluid samples from patients with the disease to those from age-matched individuals without the disease.
The first application of the test will be in the area of research, where it could be used to more effectively screen patients who participate in clinical trials. The current methodology to test for Alzheimer’s includes cognitive testing of memory and can have as much as a 30 to 35 per cent false positive result, says Gundel.
“That means clinicians are potentially enrolling a significant number of subjects in their studies who don’t really have the disease they are trying to treat and that makes it very difficult to determine how well your drug is working,” he said. “An accurate diagnostic test like the one we’re developing can dramatically facilitate research and development efforts and hopefully get new treatments out on the market sooner at a lower cost.”
Alzheimer’s disease currently affects more than five million people across North America and that number is expected to grow as the population of baby boomers ages. The breakthrough by Amorfix represents an important milestone in furthering the early detection and subsequent treatment of the disease. The company is also working on a project to take the same biochemical test and adapt it to measure the same substance in a patient’s blood.
“That’s the holy grail,” said Gundel. “Because then it’s just a simple blood test which would totally revolutionize the way the disease is diagnosed and treated. We have already been able to measure aggregated beta amyloid in the plasma of a number of animal models used for Alzheimer’s disease preclinical research which helps pave the way for the development of a test for humans.
About Amorfix
Amorfix Life Sciences Ltd. is a product development company focused on diagnostics and therapeutics for misfolded protein diseases including Alzheimer’s disease, cancers and ALS. Amorfix applies its computational discovery platform, ProMIS™ to predict novel disease specific epitopes (DSEs) on the molecular surface of misfolded proteins. The company’s lead programs include therapeutics and companion diagnostics for cancers, antibodies and vaccines to DSEs in ALS and Alzheimer’s diagnostic tests. Its proprietary Epitope Protection™ technology also enables it to specifically identify very low levels of misfolded proteins in a biological sample. Amorfix’s diagnostic programs include an ultrasensitive method for the detection of aggregated beta-Amyloid in brain tissue, cerebral spinal fluid and blood from animal models of Alzheimer’s, months prior to observable amyloid formation and development of a human screening test. For more information about the company, visit www.amorfix.com.
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