Adeona Pharmaceuticals, Inc. (AMEX: AEN), a specialty
pharmaceutical company dedicated to the awareness, diagnosis,
prevention and treatment of zinc deficiency and chronic copper
toxicity in the mature population, today announced that it
presented results of a 90 subject prospective, blinded,
observational clinical study to evaluate copper and zinc status in
Alzheimer's disease, Parkinson 's disease and normal subjects. The
results were presented at the 2009 International Conference on
Alzheimer's Disease (ICAD) in Vienna, Austria. Two separate sets of
study results were presented, titled respectively, "Alzheimer's
Patients Exhibit Defective Serum Ceruloplasmin Associated with
Defective Copper Binding" and "Sub-Clinical Zinc Deficiency Found
in Alzheimer's Disease."
During 2007 and 2008, Adeona sponsored and conducted an
IRB-approved, prospective, observational, blinded clinical trial
enrolling 90 subjects, 30 with Alzheimer's disease (AD), 30 with
Parkinson's disease (PD) and 30 age-matched normal subjects at the
Alzheimer's Center at Albany Medical Center, led by principal
investigator Earl A. Zimmerman, M.D., Director of the Alzheimer's
Center and Director of Clinical Research for the Neurosciences
Institute at Albany Medical Center. The purpose of the study was to
evaluate serum markers of copper status, compare these results
across the three groups of patients and confirm the findings of
other research groups finding evidence of serum copper
dyshomeostasis in AD.(1)
After IRB approval, normal subjects were recruited by referral
and media. AD patients not taking zinc or copper supplements were
recruited from the Albany Medical Center's clinical practice by
standard tests and NINDS-ADRDA criteria. AD patients and normals
provided morning blood draw after overnight fast.
The results showed that AD and normal patients had comparable
serum ceruloplasmin levels. The ceruloplasmin of AD patients,
however, had significantly lower enzymatic activity (p=0.0017) and
was also associated with a lower copper to ceruloplasmin ratio
(p=0.000086), indicating less copper bound per unit of
ceruloplasmin. Averaging these respective ceruloplasmin defects
yielded a p value of p=0.0000015. The estimated percent of serum
copper not bound to ceruloplasmin (i.e., "free serum copper") was
elevated by 28.9% in AD patients compared to normals (p=0.045), as
did Parkinson's disease patients compared to normals (26.5%
increase in percent free serum copper; p=0.041).
These data find a significant percentage of defective serum
ceruloplasmin in AD patients and that such defect is associated
with ceruloplasmin lacking bound copper. Defective ceruloplasmin in
AD patients may imply reduced capacity to protect from chronic
soluble inorganic copper exposure. Chronic soluble inorganic copper
exposure and its attendant toxicity have been implicated in the
progression of AD.
"The results of this study confirm and extend the findings of
other researchers of a significant copper handling defect that is
evident in the serum of AD patients. More than just a biomarker,
the availability of a quantitative serum copper status panel to be
offered to physicians through Adeona's CLIA-certified HartLab
clinical laboratory subsidiary, opens up the possibility for a new
paradigm in the treatment planning and monitoring of AD patients,"
stated David A. Newsome, M.D., who presented the results at ICAD
2009.
Adeona also exhibited and introduced HartLab to the 4,000+
international clinician and researcher attendees of ICAD. Strong
interest in HartLab's specialty copper status profile was expressed
by clinicians worldwide.
The study also found, for the first time, a statistically
significant sub-clinical zinc deficiency in AD subjects. AD
subjects had 13% lower zinc concentrations as a group compared to
normals (69.3 �g/dL vs. 79.5 �g/dL; p=0.013), as well as compared
to PD subjects (74.9 �g/dL; p= 0.046).
"This first time finding carries particular excitement since, as
with the finding of zinc deficiency in age-related macular
degeneration (AMD), it strongly supports the use of zinc therapy in
AD," commented David A. Newsome, M.D., President of Adeona's
HeathMine subsidiary and discoverer and pioneer of oral zinc
therapy for AMD, another common chronic neurodegenerative disease
of the mature population.
Adeona has filed utility patent applications covering various
aspects of its findings and is planning to initiate a clinical
trial of its patent pending modified release oral zinc therapy for
AD in the near future.
About Adeona Pharmaceuticals, Inc.
Adeona Pharmaceuticals, Inc. (AMEX: AEN) is a specialty
pharmaceutical company dedicated to the awareness, diagnosis,
prevention and treatment of subclinical zinc deficiency and chronic
copper toxicity in the mature population. Adeona believes that such
conditions may contribute to the progression of debilitating
degenerative diseases, including, Dry Age-Related Macular
Degeneration (Dry AMD), Alzheimer's disease (AD) and mild cognitive
impairment (MCI) in susceptible persons. Adeona is also developing
a number of late-stage clinical drug candidates for the treatment
of rheumatoid arthritis and multiple sclerosis. For further
information, please visit www.adeonapharma.com.
About HealthMine, Inc.
HealthMine, Inc., a subsidiary of Adeona Pharmaceuticals Inc.,
is a health education communication and information resource
company dedicated to raising awareness of subclinical zinc
deficiency and the risks of chronic copper toxicity in the mature
population. HeathMine currently hosts two Web 2.0 websites,
www.healthmine.com and the recently launched www.copperproof.com, a
new informational website dedicated to increasing awareness of the
potential health effects of chronic copper toxicity, especially in
the mature population. By visiting www.copperproof.com, users can
view a brief informational video, review relevant literature,
obtain a sensitive test card to test their tap water for copper
and, should they wish to participate in HealthMine's CopperProof
National Tap Water Survey, share their levels of copper in tap
water and geographically compare such levels to those of others.
Since 2003, an increasing body of research continues to implicate
chronic copper exposure as a potential factor that may contribute
to the progression of diseases of the mature population, especially
Alzheimer's disease.
This release includes forward-looking statements on Adeona's
current expectations and projections about future events. In some
cases forward-looking statements can be identified by terminology
such as "may," "should," "potential," "continue," "expects,"
"anticipates," "intends," "plans," "believes," "estimates," and
similar expressions. These statements are based upon current
beliefs, expectations and assumptions and are subject to a number
of risks and uncertainties, many of which are difficult to predict
and include statements regarding designing additional clinical
trials for oral dnaJP1, Zinthionein, flupirtine, or Trimesta.
Adeona is at an early stage of development and may not ever have
any products that generate significant revenue. Important factors
that could cause actual results to differ materially from those
reflected in Adeona's forward-looking statements include, among
others, a failure of Adeona's product candidates to be demonstrably
safe and effective, a failure to obtain regulatory approval for the
company's products or to comply with ongoing regulatory
requirements, regulatory limitations relating to the company's
ability to promote or commercialize its products for awareness,
prevention, diagnosis or treatment of subclinical zinc deficiency
and chronic copper toxicity, a lack of acceptance of Adeona's
product candidates in the marketplace, a failure of the company to
become or remain profitable, that we will continue to meet the
continued listing requirements of the American Stock Exchange
(which, unlike other exchanges, does not require us to maintain any
minimum bid price with respect our stock but does require us to
maintain a minimum of $4 million in stockholders' equity during the
current year, for example), our inability to obtain the capital
necessary to fund the company's research and development
activities, a loss of any of the company's key scientists or
management personnel, and other factors described in Adeona's
report on Form 10-K for the year ended December 31, 2008, Form 10-Q
for the quarter ending March 31, 2009 and any other filings with
the SEC. No forward-looking statements can be guaranteed and actual
results may differ materially from such statements. The information
in this release is provided only as of the date of this release,
and Adeona undertakes no obligation to update any forward-looking
statements contained in this release on account of new information,
future events, or otherwise, except as required by law.
(1) See, for example, Squitti R, Bressi F, Pasqualetti C et.
al., Longitudinal prognostic value of serum "free" copper in
patients with Alzheimer's disease, Neurology, 2009 72:50-55.
For Further Information Contact: Max Lyon CEO and President
Adeona Pharmaceuticals, Inc. (734) 332-7800
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