Amorfix Begins Offering EP-AD Diagnostic for Alzheimer's Disease Drug Development
TORONTO, Ontario - November 21, 2012 - In response to interest from the drug development industry, Amorfix Life Sciences Ltd. announced today that it is offering the EP-AD assay service to customers and that a number of pharmaceutical companies are currently evaluating the test in several pilot studies.
Amorfix previously announced that the EP-AD test has shown a significant increase in aggregated Abeta levels in CSF samples from AD patients and patients with mild cognitive impairment (MCI) compared to age-matched control subjects. More recently, the Company announced that it has found a statistically significant correlation between aggregated Abeta levels and minimental state examination (MMSE) scores in normal aged individuals suggesting that the EP-AD test may be able to capture the transition from normal aging to MCI. In a study conducted by the Company, the ED-AD CSF test was more sensitive at identifying individuals with MCI (94% sensitivity) than current biomarkers (monomeric Abeta 42 and phospho-tau). The Amorfix diagnostic offers several distinct advantages over the other tests. It measures small aggregates of Abeta (called oligomers) which are thought to be responsible for the major part of Abeta toxicity, and are regarded as the most relevant molecule in disease pathogenesis. In addition, the ED-AD CSF test can identify early-stage patients before they progress into frank AD.
Alzheimers disease progresses through three defined phases: a stage characterized by amyloid buildup in the brain without any symptoms of the disease, MCI predominantly affecting memory function, and full-blown Alzheimers disease. Loss of memory is common in normal aging. Diagnostic tools are needed to differentiate between mere age related loss of memory and early onset of AD.
Dr. Robert Gundel, President and CEO of Amorfix said, "We are very excited to launch this new service that will provide greatly needed information on the identification of early-stage AD and assist in the development of novel compounds for the treatment of this devastating disease. The results of recent AD trials have indicated that the best chance of slowing down the disease process is to treat patients with early-stage disease. The EP-AD assay has excellent sensitivity for early-stage diagnosis and enrolment into clinical trials. In addition, this assay has the potential for use as a biomarker to track the effectiveness of treatment to reduce or prevent plaque formation over time".
Amorfix is currently providing the diagnostic assay technology to a number of pharmaceutical and biotech companies on a fee-for-service basis. The data generated by these studies will expand the database and experience with the assay and help to validate its use as a general diagnostic for AD.
About Alzheimer's disease
More than 35 million people worldwide have Alzheimer's disease or other types of dementia. Alzheimer's disease is the most common type of dementia and accounts for an estimated 60-80 percent of cases. As the population around the world ages, the incidence of Alzheimer's disease is predicted to increase significantly. Barring a significant medical breakthrough, predictions are that cases of dementia will nearly double every 20 years, and by 2040, the number of cases around the world will quadruple to approximately 81 million people. A major stumbling block to the development of effective therapies is the absence of robust biomarkers that can be used for early detection and clinical monitoring during clinical trials. There is an obvious need for a diagnostic tool that can properly identify patients with AD in order for current therapeutics to be effective, and for enrollment into clinical trials designed to target these biomarker proteins.
Amorfix Life Sciences Ltd. (TSX:AMF) is an early-stage product development company developing therapeutic antibodies and diagnostics targeting misfolded protein diseases. Amorfix utilizes its computational discovery platform, ProMISTM, to predict novel Disease Specific Epitopes (DSEs) on the molecular surface of misfolded proteins. Using this technology, Amorfix is developing novel antibody therapeutics and companion diagnostics for cancer and amyotrophic lateral sclerosis (ALS). In addition, Amorfix has developed two proprietary technologies to specifically identify very low levels of misfolded proteins in a biological sample: Epitope ProtectionTM and AMFIATM, an ultra-sensitive dual-bead immunoassay. Use of these technologies has generated a cerebrospinal fluid (CSF) screening test for Alzheimer's disease, and an ultrasensitive method for detecting the hallmark of AD, aggregated beta-Amyloid, in brain tissue, CSF and blood from animal models of AD. For more information about Amorfix, visit www.amorfix.com.
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, unless required by law.
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ProMISTM, Epitope ProtectionTM and AMFIATM are trademarks of Amorfix Life Sciences Ltd.