TORONTO, Ontario – January 29, 2013 – Amorfix Life Sciences Ltd. announced today that the Company will collaborate with QPS Holdings, LLC, a leading global provider of discovery and development services for pharmaceutical, biotechnology and medical device companies, to further develop and validate its proprietary Alzheimer’s disease diagnostic EP-AD assay.
The companies will work together to obtain and analyze cerebral spinal fluid (CSF) samples from a variety of Alzheimer’s disease patients in various stages of disease. Amorfix and QPS will perform the studies necessary to validate and ultimately commercialize the EP-AD assay for use as both a biomarker to facilitate clinical development of new treatments for AD, and an FDA-approved early-stage diagnostic test for AD.
“We are looking forward to working with QPS to validate our EP-AD assay,” said Dr. Robert Gundel, Amorfix President and CEO. “Our studies using the EP-AD assay demonstrate that the EP-AD assay is able to identify early-stage patients with mild cognitive impairment (MCI) with a sensitivity of 94%, higher than the sensitivity achieved with other biomarkers used as comparators in the same study. AD is one of the most active areas of therapeutic development with more than 93 new treatments being evaluated in clinical studies. We believe that with QPS,we can bring the EP-AD assay to market quickly.”
“To promote successful drug development within this challenging indication, QPS aims to explore new biomarkers that will facilitate early diagnosis and enable meaningful evaluation of drug efficacy for neurodegenerative disorders,” said Ben Chien, CEO of QPS. “As a leading neuroscience CRO, we will work with our partner to develop a wide panel of new biomarkers for experimental and clinical use.”
Amorfix will also continue to provide the EP-AD assay for research use to pharmaceutical and biopharmaceutical companies on a fee for service basis.
About Alzheimer’s disease
More than 35 million people worldwide have Alzheimer’s disease or some other type of dementia. AD is most common, and accounts for an estimated 60–80 percent of cases. Barring a major medical breakthrough, as the world’s population ages, cases of dementia are predicted to nearly double every 20 years. By 2040, the number of cases around the world will have quadrupled to approximately 81 million people. A major stumbling block to the development of effective therapies is the absence of robust biomarkers for early detection, and monitoring during clinical trials. A diagnostic tool that can properly identify patients with early AD is needed in order for current therapeutics to show effectiveness, and for enrolment of such patients into clinical trials.
QPS is a GLP/GCP-compliant CRO that supports discovery, preclinical, and clinical drug development. We provide quality services in Neuropharmacology, DMPK, Toxicology, Bioanalysis, Translational Medicine, and Early Stage & Phase II – IV Clinical Research to clients worldwide. Our regional facilities and offices are located in the USA, China, Taiwan, Japan, India, Netherlands, Austria, Czech Republic, Lithuania, Ukraine, Romania, Poland, Croatia, Slovenia, Serbia, Bosnia, Hungary, Israel, France, Spain, Germany and the United Kingdom.
Business development offices are maintained throughout the US, Europe, and Asia. QPS employs more than 1000 professionals at ten sites in nine countries on four continents. In concert with its global expansion, the company is proud of and strives to maintain a friendly and caring company culture at all of its business sites.
QPS has years of experience in neuroscience, as well as global research resources and capabilities including early in vitro work, proprietary animal models, focus on CNS-specific DMPK issues such as BBB penetration, IND-enabling toxicology and clinical research. QPS provides important technologies for Phase I clinical trials, such as continuous CNS sampling, PET, MRI and sensitive cognitive testing methods, and is able to apply these techniques to highly complex Phase II/III trials, including CSF sampling and functional and structural imaging.
Global expertise in this field guarantees top-level scientific consultation and research services.
For more information, please visit www.qps.com.
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, ProMIS™, 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 Protection™ and AMFIA™, an ultra-sensitive dual-bead immunoassay. Use of these technologies has generated the EP-AD assay, a cerebrospinal fluid (CSF) screening test for Alzheimer’s disease (AD) and mild cognitive impairment (MCI), and the A4 assay, 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.