ANN ARBOR, MI -- 11/09/09 --
Adeona Pharmaceuticals, Inc. (AMEX: AEN)
announced today that it has initiated the U.S. launch of its high precision
diagnostic test panel for the comprehensive evaluation of zinc and copper
status in patients with Alzheimer's disease (AD) and mild cognitive
impairment (MCI). The CopperProof Test Panel(TM) will be offered through
the company's HartLab LLC clinical laboratory subsidiary and will provide a
comprehensive look at the metabolic serum copper and zinc status of AD and
MCI patients, which status has been shown to be impaired in this patient
population. Defects in copper metabolism and high free copper levels are
increasingly being recognized as significant factors in the progression of
neurodegenerative diseases, including AD and MCI. A clinical zinc
deficiency in AD patients has also been recognized for the first time in a
recent Adeona-sponsored clinical study.
Adeona has hired a specialty sales force to bring the CopperProof Test
Panel to neurologists, psychiatrists, gerontologists, nursing homes and
other physicians that regularly treat patients with AD and MCI in selected
key U.S. markets. The company will continue to build its specialty sales
force with individuals having extensive experience calling on these
physician practices and will expand its sales efforts to eventually cover
the entire U.S. market. It is estimated that 25 million Americans suffer
from Alzheimer's disease or cognitive impairment. The Alzheimer's
Association estimates that $148 billion is spent each year caring for AD
patients. Therapeutic products for AD and MCI represent an existing
multi-billion dollar U.S. market. Current treatment solutions generally
provide only symptomatic relief and are inadequate to halt the progression
and devastating effects of AD and MCI, creating a significant market
opportunity for new, potentially disease modifying solutions.
A teleconference call has been scheduled for 1:00p.m. EST today to discuss
the product launch. Participants may join the teleconference by dialing
888-471-3841 just prior to 1:00p.m. EST. The passcode is 4751078. A replay
of the teleconference will be available on Adeona's website for at least 15
days following the call.
On July 9, 2009 Adeona completed the acquisition of HartLab LLC, a
CLIA-certified clinical reference laboratory located in Bolingbrook,
Illinois. On July 15, 2009, Adeona presented the results of the CopperProof
1 Study, a prospective observational study comparing serum parameters of
copper and zinc status in patients with Alzheimer's disease, Parkinson's
disease and normal subjects, at the 2009 International Conference on
Alzheimer's Disease (ICAD) in Vienna, Austria. This study showed a strong
correlation between Alzheimer's disease and impaired serum copper binding
as well as elevated percent free (non-ceruloplasmin bound) serum copper
levels in AD patients. The study also reported, for the first time,
clinical and subclinical zinc deficiency in AD patients.
The CopperProof Test Panel, developed at HartLab, will potentially identify
patients with defective serum ceruloplasmin, elevated percentages of serum
free copper level as well as zinc deficiency. Adeona believes that defects
in copper metabolism and elevated percentages of serum free copper
(non-ceruloplasmin bound) predisposes certain persons to enhanced
susceptibility to the neurotoxic effects of copper, which include the
aggregation, and reduced clearance, of oxidative copper in the beta amyloid
plaques and neurofibrillary tangles, the hallmark brain pathologies of
Alzheimer's disease (1-5). To learn more about the CopperProof Test Panel
and HartLab, please visit www.hartlab.com.
On November 2, 2009, Adeona announced that it had received Institutional
Review Board (IRB) approval to initiate a 60 patient, randomized,
double-blind, placebo-controlled clinical trial of its patent pending
Zinthionein(TM) ZC in an AD and MCI patient group. The clinical trial,
titled "CopperProof 2" will test, for the first time, the effects of a
novel gastro-retentive, sustained release zinc/cysteine combination tablet
on the amelioration of sub-clinical zinc deficiency, and elevated
percentage serum free copper, associated with Alzheimer's Disease. Adeona
believes that Zinthionein(TM) ZC will prove to be beneficial to lowering
high free copper levels and eliminating sub-clinical zinc deficiency in the
AD and MCI populations. The company further believes correcting these free
copper and zinc imbalances through dietary management may slow the
progression of AD and MCI.
Max Lyon, Adeona's CEO, stated, "We are excited to introduce our first
product offering for the very under-served Alzheimer's disease and
cognitive impaired patient population. AD and MCI have been resistant to
other therapeutic approaches, leaving many patients, and their caregivers,
with little hope of stopping the continued progression of the patient's
cognitive decline. We plan to identify those patients with copper and zinc
imbalances and to provide therapeutic alternatives, such as high dose zinc
therapy, which can correct these imbalances and may have a positive effect
in slowing the progression of disease. We consider chronic copper toxicity
and sub-clinical zinc deficiency to be a significantly under-recognized and
modifiable risk factor for the progression of AD and MCI. Using our patent
pending, modified oral zinc delivery technologies, we recently announced
initiation of the first clinical trial of oral zinc therapy,
Zinthionein(TM) ZC, for the once-a-day dietary management of AD and MCI."
About Adeona Pharmaceuticals, Inc.
Adeona Pharmaceuticals, Inc. (AMEX: AEN) is a specialty pharmaceutical
company dedicated to the awareness, diagnosis, prevention and treatment of
zinc deficiency and chronic copper toxicity in the mature population.
Adeona believes that these 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. Using Adeona's proprietary,
modified oral zinc delivery technologies, Adeona is preparing to initiate
the first clinical trial of oral zinc therapy for the once-a-day dietary
management of AD and MCI. 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 HartLab LLC
HartLab is a specialty clinical laboratory with the primary mission to be
the leading national clinical laboratory for the testing of copper and zinc
metabolic status in the mature population. Recent published scientific
studies have shown the strong relationship between high inorganic ("free")
copper levels in serum and the progression of Alzheimer's disease (AD) and
mild cognitive impairment (MCI). A recent Adeona Pharmaceuticals sponsored
study, presented at the 2009 International Congress on Alzheimer's Disease
(ICAD), showed a sub-clinical zinc deficiency in Alzheimer's patients.
HartLab has developed the CopperProof Test Panel which will provide a
definitive analysis of copper and zinc metabolic status and identify those
AD and MCI patients with high "free" copper levels and sub-clinical zinc
deficiency, as well as provide other important diagnostic results. These
individuals may be candidates for physician prescribed therapy to correct
their copper and zinc imbalances. HartLab also serves the greater Chicago
area with a full service clinical laboratory operation including a
comprehensive menu of tests. Its website is www.hartlab.com.
For further background on the role of zinc and copper imbalance in
Alzheimer's disease and mild cognitive impairment interested persons are
directed to www.copperproof.com and the following references:
1. Sparks D. and Schreurs, B., Trace amounts of copper in water induce
beta-amyloid plaques and learning deficits in a rabbit model of Alzheimer's
disease. Proc. Natl. Acad. Sci. (2003) 100: 11065-11069.
2. Sparks DL, Friedland R, Petanceska S, Schreurs BG, Shi J, Perry G, Smith
MA, Sharma A, Derosa S, Ziolkowski C, Stankovic G., Trace copper levels in
the drinking water, but not zinc or aluminum influence CNS Alzheimer-like
pathology, J Nutr Health Aging. (2006 Jul-Aug);10(4):247-54.
3. Deane R, Sagare A, Coma M, Parisi M, Gelein R, Singh I, Zlokovic B, A
novel role for copper: Disruption of LRP-dependent brain A? clearance,
Neuroscience 2007, Society for Neuroscience (Nov. 2007), Pres. 857.2
4. Kitazawa M, Cheng D, Laferla FM., Chronic copper exposure exacerbates
both amyloid and tau pathology and selectively dysregulates cdk5 in a mouse
model of AD., J Neurochem. (Mar. 2009);108(6):1550-60. Epub 2009 Jan 22.
5. Morris MC, Evans DA, Tangney CC, et al., Dietary copper and high
saturated and trans fat intakes associated with cognitive decline., Arch
Neurol. (2006) 63: 1085-1088.
6. http://www.ewg.org/tapwater/contaminants/contaminant.php?contamcode=1022
7. Committee on Copper in Drinking Water, Copper in Drinking Water,
National Research Council, National Academy Press (2000).
8. Squitti R, Bressi F, Paswualetti P, Bonomini C, Ghidoni, R, Binetti G,
Casetta E, Moffa F, Ventriglia M, Vernieri F, Rossini P., Longitudinal
prognostic value of serum "free" copper in patients with Alzheimer's
disease, Neurology, (Jan. 2009) 72: 50-55.
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 its oral zinc therapies, dnaJP1, Zinthionein, Zinthionein ZC,
flupirtine, or Trimesta. Adeona is at an early stage of development and may
not ever have any products that generate significant revenue. Adeona's
Hartlab subsidiary is generating modest revenues and its future success
will likely depend upon its ability to successfully introduce and market
new specialty diagnostic assays to generate additional revenues. 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 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, Forms 10-Q for quarters
ending in 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.
Zinthionein(TM) ZC-GS150 is a patent pending modified release formulation
containing 150mg of elemental zinc and other ingredients that does not
contain zinc-monocysteine. Zinthionein(TM) and CopperProof(TM) are a
trademarks of Adeona Pharmaceuticals, Inc. Diagnostic uses of the
CopperProof trademark are exclusively licensed by Hartlab LLC. Certain
elements of the CopperProof Test Panel are Laboratory Developed Tests and
not approved by the FDA.
For Further Information Contact:
Max Lyon
Chief Executive Officer and President
(734) 332-7800 x36