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
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