|[January 03, 2013]
Cognoptix Drug/Device Test Identifies Alzheimer's Disease via Beta Amyloid Signature in the Eyes in a 10-Subject Proof-of-Concept Clinical Trial
ACTON, Mass. --(Business Wire)--
an emerging medical device company announced today that its SAPPHIRE
II eye test identified Alzheimer's disease patients via a beta
amyloid ("Ab") signature in their eyes in a 10-subject
proof-of-concept clinical trial. By detecting a specific fluorescent
signature of ligand-marked beta-amyloid in the supranucleus region of
the human lens, SAPPHIRE II achieved a two-fold differentiation
factor between a group of five healthy volunteers and a group of five
patients diagnosed with probable Alzheimer's disease.
Cognoptix has exclusively licensed groundbreaking technology from the
University of California at San Diego ("UC San Diego"), which Cognoptix
has developed into an innovative, non-invasive eye-scanning test,
SAPPHIRE II, for the early detection and diagnosis of Alzheimer's
disease ("AD") pathology. The UC San Diego technology is the subject of
paper recently published in the peer-reviewed Journal of the
American Chemical Society ("Aminonaphthalene 2-Cyanoacrylate [ANCA]
Probes Fluorescently Discriminate between Amyloid-ß and Prion Plaques in
"Presently, there is a major effort investigating the role of beta
amyloid neuritic plaques in the brains of adult patients with cognitive
impairment and possible Alzheimer's disease," said Carl Sadowsky, M.D.,
F.A.A.N., Medical Director at Premiere Research Institute in West Palm
Beach Fla., and a principal investigator in the SAPPHIRE clinical study.
"Positron Emission Tomography (PET) imaging has been recently approved
to enable detection of beta amyloid neuritic plaques in living AD
patients. Howeve, there is a clear need for a low cost, non-invasive
technology capable of improving the differential diagnosis of dementia
which is practical for widespread use at point-of-care."
"Currently there is no early-stage non-invasive diagnostic for
Alzheimer's disease in the market," added Paul Hartung, President
and CEO of Cognoptix. "Unfortunately, patients often incur up to 50%
neuronal loss and a delay of up to two years before demonstrating severe
enough symptoms to achieve diagnosis by the current gold standard: a
'process of elimination' of other possible diagnoses such as stroke,
trauma, Parkinson's disease, dementia, etc., through extensive cognitive
and physical testing. New therapeutic drugs to slow or stop the progress
of AD are expected to reach the market soon. Cognoptix is developing a
method of early-stage diagnosis to allow treatment before
significant neuronal loss and irreversible brain damage occurs."
The Cognoptix SAPPHIRE II system consists of a laser-based reading
device and consumable ophthalmic ointment. The eye exam can be given by
a general practitioner and only takes a few minutes to achieve a result.
The Cognoptix drug/device combination is an entirely novel, early-stage
diagnostic for Alzheimer's disease designed to allow treatment before
significant neuronal loss and irreversible brain damage occurs.
Cognoptix has a strong and comprehensive patent portfolio covering
diagnosis of beta amyloid-based diseases via ophthalmic imaging. The
patent portfolio includes issued "method" and "device" patents, as well
as pending "composition of matter" patents. In addition to UC San Diego,
exclusive licenses have been acquired from Massachusetts General
Hospital and Brigham and Women's Hospital Boston.
Five (5) AD subjects (2 females, 3 males) ranging from 65 to 83 years
old met the accepted standards for Probable Alzheimer's Disease,
including an MRI brain scan ruling out stroke and/or generalized
cerebrovascular disease. Control subjects (5 males) ages 31 to 77 years
old had no evidence of cognitive impairment, and had an MRI brain scan
that was judged as "normal" (age appropriate).
There are more than 100 new Alzheimer's drugs that are in various stages
of research and development. The ability of the Cognoptix drug/device
combination to easily identify and qualify patients for clinical study
inclusion, as well as accurately and inexpensively track patient disease
progression, may provide pharmaceutical companies with a significant
competitive advantage in securing new Alzheimer's drug approvals. It may
also help identify and document differentiating pharmaceutical product
performance attributes in Phase 4 studies.
About SAPPHIRE II
Cognoptix has developed an in-office, drug/device diagnostic system
designed as an aid in the early detection of Alzheimer's Disease (AD)
pathology. A ligand or contrast agent (drug) and software-controlled
optical instrument (device) allows for noninvasive detection and
assessment of AD by measuring the hallmark of AD, beta amyloid, in the
supranuclear region of the lens of the eye. The ligand is easily
administered to the eye as an ophthalmic ointment and a proprietary
Fluorescent Ligand Scanning (FLS) instrument, provides an objective and
quantitative measurement of beta amyloid in the patient's lens.
Significantly faster and an order of magnitude less expensive than brain
imaging, the test and diagnosis can be quickly completed in any
physician's office, including general practitioners. The technology is
currently in clinical trials.
Cognoptix, a privately held medical technology company headquartered in
Acton, Mass., is focused on developing and commercializing an in-office,
drug/device diagnostic system as an aid in the early detection of
Alzheimer's Disease (AD). Its investors include Inventages Venture
Capital, one of the world's largest life sciences-, nutrition- and
wellness-focused venture capital firms; and Launchpad Venture Group,
a Boston-based angel investment firm that provides funding to
NOTE: The SAPPHIRE II system is approved for investigational use only in
the United States.
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