Adeona Pharmaceuticals, Inc. (AMEX: AEN), a specialty
pharmaceutical company dedicated to the awareness, prevention and
treatment of subclinical zinc deficiency and chronic copper
toxicity in the mature population, today announced that it has
appointed David A. Newsome, M.D., President of Adeona's subsidiary,
HealthMine, Inc. ("HealthMine").
While serving as the Section Chief of Retina and Ocular
Connective Tissue Diseases at the National Eye Institute (NEI), Dr.
Newsome discovered the link between subclinical zinc deficiency and
Dry Age-Related Macular Degeneration (Dry AMD). Dry AMD is a
chronic degenerative disease that affects approximately 17 million
mature adults in the U.S. and is the leading cause of blindness in
mature adults.
Dr. Newsome conducted and published the first clinical trial to
test the potential utility of oral high dose zinc supplementation
for Dry AMD, which proved to be highly successful and made oral
high dose zinc the current standard of care for Dry AMD. Dr.
Newsome's results were later reproduced in the NEI's landmark 6,000
patient Age Related Eye Disease Study (AREDS), finding both reduced
vision loss and reduced mortality among dry-AMD patients treated
with oral high dose zinc.
Dr. Newsome is also the inventor of Adeona's exclusively
licensed zinc-monocysteine complex, a patented complex of zinc and
the amino acid cysteine, which Dr. Newsome and Adeona believe may
have improved properties compared to forms of zinc currently used.
In a six month, randomized, double-masked, placebo controlled trial
of zinc-monocysteine in 80 mature adults with Dry AMD,
zinc-monocysteine demonstrated highly statistically significant
improvements in global parameters of central retinal function,
including visual acuity, contrast sensitivity and photorecovery
times, the results of which were published in the peer-reviewed
journal, Current Eye Research, in July 2008.
Dr. Newsome has lectured extensively to raise awareness and
educate physicians on the subject of subclinical zinc deficiency in
the mature population, particularly Dry AMD, and was a driving
force behind making oral high dose zinc supplementation the
standard of care for Dry AMD. Oral high dose zinc supplements
utilized for the dietary management of Dry AMD currently sell
approximately $300 million annually and include twice-daily brands,
such as PreserVision and Ocuvite, marketed by Bausch & Lomb, as
well as iCaps, marketed by Alcon.
In his new capacity as President of HealthMine, Dr. Newsome will
oversee all aspects of HealthMine's health education communication
and information resources dedicated to raising awareness of
subclinical zinc deficiency and the risks of chronic copper
toxicity in the mature population. This will include the management
and growth of HealthMine's future media and communication plans,
including the growth of its initial websites, healthmine.com and
the recently launched copperproof.com.
Dr. David Newsome commented, "Having reviewed the results of
Adeona's recently completed clinical study, I find evidence of
subclinical zinc deficiency in Alzheimer's disease to be highly
reminiscent of my early findings of subclinical zinc deficiency in
Dry AMD. Given the 20 years of proven clinical benefit of oral high
dose zinc for Dry AMD, which is now the standard of care for Dry
AMD and used by millions of Americans every day, I look forward to
sharing my experience and raising awareness of subclinical zinc
deficiency and the risks of chronic copper toxicity with physicians
responsible for the care of the 20 million Americans with
Alzheimer's disease and mild cognitive impairment (MCI)."
Dr. Newsome served as Chief Scientific Officer of Adeona during
2007 and 2008 and has remained a consultant to Adeona. Prior to
joining Adeona in October 2007, Dr. Newsome practiced as a Retina
Specialist and Retino-vitreal Surgeon in the Tampa Bay area, after
serving 14 years as President of the Retinal Institute of
Louisiana, as well as serving as Clinical Professor of
Ophthalmology at the Tulane University School of Medicine, and
Professor of Ophthalmology at the Louisiana State University
Medical Center. In addition to active clinical practice, Dr.
Newsome continued to pursue laboratory and clinical research. He
also held positions as Associate Professor of Ophthalmology at
Johns Hopkins University. From the late '70s to early '80s he was
the Section Chief of Retina and Ocular Connective Tissue Diseases
at the National Eye Institute (NEI). Dr. Newsome has authored over
150 peer-reviewed scientific publications, lectured extensively and
has contributed greatly to the increased awareness and treatment of
subclinical zinc deficiency among mature persons having Dry
AMD.
Dr. Newsome earned a B.A. from Duke University and an M.D. from
Columbia University.
About HealthMine
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.
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
(Normals). The purpose of the study was to evaluate serum markers
of copper status and compare these results across the three groups
of patients. The results of our study indicate highly statistically
significant differences in serum markers of copper status between
AD and normal subjects. We believe that the differences observed
suggest that Alzheimer's patients have impaired protection from
chronic copper toxicity, which may contribute to the progression of
their disease. The results from this study also appear to indicate
a subclinical zinc deficiency in AD subjects. Adeona and HeathMine
intend to publish these results in the future.
About Adeona Pharmaceuticals, Inc.
Adeona Pharmaceuticals, Inc. (AMEX: AEN) is a specialty
pharmaceutical company dedicated to the awareness, 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.
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 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. PreserVision and Ocuvite are registered trademarks
of Bausch & Lomb and iCaps is a registered trademark of Alcon,
Inc.
For Further Information Contact: Steve H. Kanzer, CPA, JD
Chairman and CEO Adeona Pharmaceuticals, Inc. (734) 332-7800 x39
David A. Newsome, M.D. President HealthMine, Inc. (734) 332-7800
x10
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