ROCKVILLE, Md., Jan. 24 /PRNewswire/ -- Adlyfe, a private company developing novel diagnostic testing technologies for early targets of amyloid diseases, announced today that the United States Patent and Trademark Office (PTO) issued patent number 7,166,471, entitled, "Misfolded Protein Sensor Method in Body Fluids." This patent covers a novel and highly effective method for rapid diagnostic testing of blood and other bodily fluids for the early detection of more than 40 amyloid diseases such as Alzheimer's disease (AD), Creutzfeldt-Jakob disease (the human variant of "Mad Cow" disease), Parkinson's disease, Huntington's disease, systemic amyloidosis, diabetes and other diseases.
Chief Executive Officer Alan S. Rudolph, Ph.D., said, "This patent is a significant milestone for our Company and our investors as it anchors our existing IP portfolio and provides us with the foundation to offer a novel, fast, highly sensitive and accurate diagnostic test for the detection of Alzheimer's disease and other amyloid misfolded protein diseases. Early and accurate diagnosis may accelerate and improve treatment and other intervention options for patients. In addition, diagnostic testing may also play an important role in future clinical trials of therapeutic candidates for these diseases by quantifying the presence or absence of misfolded amyloid proteins and potentially evaluating drug efficacy and dosing.
"Our primary goal is to commercialize a diagnostic test for Alzheimer's within the next two to three years," said Rudolph.
Cindy Orser, Ph.D., Adlyfe's Vice President of Research and Development, and one of the three inventors, said, "Unlike most diseases, amyloid diseases such as Alzheimer's have long lacked a readily available, fast and accurate detection method to aid diagnosis. By combining detection and amplification, our first-in-class method provides highly accurate test results derived from low concentrations of target proteins within bodily fluids such as blood and cerebrospinal fluid. This novel approach delivers superior performance compared to antibody-based molecular binding or genomics-based diagnostics."
This catalytic detection method screens for very low concentrations of misfolded proteinaceous particles, such as proteins in serum or blood, which may identify asymptomatic patients. Currently, there is no easily administered test to diagnose AD; definitive diagnosis of Alzheimer's disease relies on examination of the brain, usually at autopsy.
"An early diagnostic test for Alzheimer's is greatly needed, particularly one that reflects the underlying amyloid pathology," said Paul Aisen, M.D., Professor, Georgetown University Medical Center Department of Neurology. "Such a test may allow classification of patients with early symptoms and may provide important guidance for the development and use of anti-amyloid treatments."
"As the number of potential cases grows, it becomes even more important that early detection be followed by access to community services," said Anthony K. Sudler, President & CEO, National Capital Area, Alzheimer's Association. "Diagnostic tests that provide early indication of Alzheimer's will enable better care for those suffering and in need of better medicine and available services."
About U.S. Patent 7,166,471
The inventors of the discovery are Cindy Orser, Ph.D., Anne Grosset, Ph.D., and Eugene A. Davidson, Ph.D. Dr. Orser serves as Adlyfe's Vice President of Research and Development and has over 20 years in biotechnology industry. Dr. Davidson serves as Professor of Biochemistry and Molecular Biology at Georgetown University School of Medicine. Dr. Grosset is Head of Polymer Chemistry for SICPA in Basel, Switzerland.
The abstract for U.S. Patent 7,166,471 describes the invention as follows:
"A catalytic conformational sensor method for detecting abnormal proteins and proteinaceous particles. The method is based on the interaction of a peptide fragment or probe with an abnormal proteinaceous particle. The interaction catalyzes transformation of the probe to a predominantly beta sheet conformation and allows the probe to bind to the abnormal proteinaceous particle. This in turn, catalyzes propogation of a signal associated with the test sample-bound probe. As a result signals can be propogated even from samples containing very low concentrations of abnormal proteinaceous particles as is the case in many body-fluid derived samples."
A full copy of the issued patent can be found here: http://patft.uspto.gov/netacgi/nph- Parser?Sect1=PTO2&Sect2=HITOFF&p=1&u=%2Fnetahtml%2FPTO%2Fsearch- bool.html&r=1&f=G&l=50&co1=AND&d=PTXT&s1=7,166,471&OS=7,166,471&RS=7,166,471 or searched for here: http://patft.uspto.gov/netahtml/PTO/search-bool.html with the search term 7,166,471.
About Alzheimer's disease
Alzheimer's disease (AD) is a neurodegenerative disease characterized by progressive cognitive deterioration together with declining activities of daily living and neuropsychiatric symptoms or behavioral changes. It is the most common type of dementia. As the disorder progresses, cognitive impairment extends to the domains of language, skilled movements, recognition, and those functions closely related to the frontal and temporal lobes of the brain. This pathological process consists principally of neuronal loss or atrophy, principally in the temporoparietal cortex but also in the frontal cortex, together with an inflammatory response to the deposition of amyloid plaques and neurofibrillary tangles. According to the NIH's National Institute on Aging, as many as 4.5 million Americans presently suffer from Alzheimer's disease.
Adlyfe, a privately-held corporation, was initially funded by the Defense Advanced Research Projects Agency (DARPA), the central research and development organization for the Department of Defense, with more than $7 million raised from Government agencies including DARPA, the U.S. Army Medical Research and Materiel Command, the National Heart, Lung and Blood Institute, and Britain's Department for Environment, Food and Rural Affairs. More recently, Adlyfe raised an additional $3.3 million in a Series A round of funding with venture capital firms Canaan Venture Partners and Burrill Associates.
Adlyfe Inc. was established early in 2003 to develop novel technologies for blood testing for early targets of amyloid diseases. Adlyfe is developing a novel test for the detection and amplification of amyloid proteins as early biomarkers of fatal brain and amyloid diseases such as Alzheimer's disease, Parkinson's disease, Creutzfeldt-Jacob disease, Huntington's disease, systemic amyloidosis, diabetes and other diseases.
The Company's novel technology is based on the synthesis of small peptide, or PronucleonTM ligands, that are amino acid sequence matched to target amyloids of interest. Ligand sequences are selected based on regions of the target protein known to undergo conformational changes (structural changes in shape) associated with amyloid aggregation (and eventual amyloid plaque formation). These aggregates are associated with disease state progression in a number of brain-wasting and amyloid diseases.
This unique and novel diagnostic method for the early detection of malformed proteins associated with brain-wasting and amyloid diseases in both humans and other mammals has significant positive potential ramifications for human health, early disease detection, and use in clinical trials of potential drug candidates for the treatment of these serious diseases. Internet Website: http://www.adlyfe.com