ANN ARBOR, Mich., Dec. 16, 2010 /PRNewswire-FirstCall/ --
Adeona Pharmaceuticals, Inc. (NYSE Amex: AEN), a developer of
innovative medicines for serious central nervous system diseases,
announced today that it has acquired access to clinical data
supporting a zinc-based therapy for the prevention of infections in
the elderly. This acquisition expands and enhances Adeona's
zinc-based product candidate portfolio that already includes its
proprietary zinc-based tablets for use in the dietary management of
mild to moderate Alzheimer's disease and mild cognitive impairment
patients, and age-related macular degeneration. In addition, Adeona
also announced the appointment of the zinc research pioneer,
Ananda S. Prasad, M.D., Ph.D., to
the Company's Scientific Advisory Board.
"I am pleased to join the Scientific Advisory Board of Adeona, a
company leading the development of zinc-based therapies addressing
diseases in the elderly," said Ananda S.
Prasad, M.D., Ph.D. "I look forward to providing guidance as
Adeona moves their promising zinc-based product candidates through
development."
Zinc for Prevention of Infection in the Elderly
Adeona has entered into an agreement with Dr. Prasad that
provides the Company with access to clinical data from a 50
patient, 12-month, randomized, double-blind, placebo-controlled
clinical trial that evaluated the prevention of infection in
patients age 55 to 87 who were treated with an oral zinc therapy
(45 mg elemental zinc per day away from food) or matching placebo.
The clinical trial was conducted by Dr. Prasad and
co-investigators. The primary endpoint of the clinical trial was
the rate of infections between the placebo and zinc treated groups.
The results at 12 months demonstrated a 67% reduction in the
incidence of infection between the two groups (88 infections in the
placebo group versus 29 infections in the zinc treated group) (p
less than 0.001).(1)
Adeona's Portfolio of Zinc-Based Therapies for Diseases in
the Elderly
Adeona is developing a portfolio of proprietary oral zinc-based
therapies that is expected to offer superior benefits including
improved convenience, bioavailability and gastrointestinal
tolerability for major diseases of the elderly. The Company
considers zinc deficiency of the elderly to be a major public
health issue, with zinc deficiency implicated in age-related
macular degeneration, Alzheimer's disease, complications of
diabetes mellitus and impaired immune function.(2) Declines in
serum zinc levels and impaired zinc absorption in the elderly are
well documented in multiple clinical studies. Adeona is currently
conducting a controlled clinical trial to test its proprietary
zinc-based therapy for Alzheimer's disease and mild cognitive
impairment. All 60 patients should complete their 6 month treatment
by the end of March 2011 and it is
anticipated that top-line clinical study results should be
available shortly thereafter. Adeona's product candidate for
age-related macular degeneration has been successfully evaluated in
an 80 patient, randomized, placebo-controlled clinical trial. This
trial demonstrated statistically significant improvements in
multiple parameters of retinal function.
Adeona believes that the product opportunity announced today
represents a natural extension of the Company's leading position in
developing oral zinc-based therapies for major diseases in the
elderly. According to the U.S. Centers for Disease Control,
infections attributable to influenza and pneumonia represent the
4th leading cause of death of people age 65 and over in
the United States. Influenza and
pneumonia alone are estimated to claim the lives of 58,000 seniors
a year and infections in seniors are also a major burden on the
public health care system.(3)
"We are excited to add a product candidate for the prevention of
infection to our zinc-based portfolio. Utilizing our clinical
experience from our Alzheimer's disease and age-related macular
degeneration zinc-based product candidates, we have increased
opportunities to address the unmet need of zinc deficiency in the
elderly," stated James S. Kuo, M.D.,
M.B.A., Adeona's Chairman and CEO. "We are also very pleased to
have Dr. Prasad, an esteemed pioneer of zinc therapy with over 50
years of experience devoted to the field, accept our invitation to
join our Scientific Advisory Board, and we look forward to his
valuable contributions."
About Ananda S. Prasad, M.D.,
Ph.D.
Ananda S. Prasad, M.D., Ph.D., a
Distinguished Professor of Internal Medicine at Wayne State University School of Medicine and
renowned zinc expert, recently received the 2010 Mahidol Award in
the Field of Public Health for his groundbreaking research. Among
his many achievements, he is credited for identifying zinc
deficiency as the underlying cause of growth retardation and
hypogonadism that has afflicted millions of children in the
developing world. Dr. Prasad estimates that over 2 billion people
worldwide currently suffer from zinc deficiency. For over five
decades, he has been a vocal advocate of zinc supplementation for
diseases characterized by zinc deficiency. Dr. Prasad is the 2007
recipient of the American College of Physicians Award for
Outstanding Work in Science as Related to Medicine and has over 200
peer-reviewed publications.
About Adeona Pharmaceuticals, Inc.
Adeona is a pharmaceutical company developing innovative
medicines for the treatment of serious central nervous system
diseases. The Company's strategy is to license product candidates
that have demonstrated a certain level of clinical efficacy and
develop them to a stage that results in a significant commercial
collaboration. Currently, Adeona is developing the following
product candidates: a prescription medical food for Alzheimer's
disease, and drugs for multiple sclerosis, fibromyalgia, rheumatoid
arthritis and age-related macular degeneration. For more
information, please visit Adeona's website at
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 the timing and results of our
clinical study and our ability to successfully develop products
with superior benefits. The forward-looking statements are subject
to risks and uncertainties that could cause actual results to
differ materially from those set forth or implied by any
forward-looking statements. 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 our clinical trials to be completed on time or to
achieve desired results, a failure of our clinical reference
laboratory to continue to grow and achieve revenue or a failure by
us or our strategic partners to successfully commercialize products
and other factors described in Adeona's report on Form 10-K for the
year ended December 31,
2009 and any other filings with the SEC. 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)Prasad AS, Beck FWJ, Bao B, Fitzgerald JT, Snell DC,
Steinberg JD, Cardozo LJ, Zinc supplementation decreases incidence
of infections in the elderly: effect of zinc on generation of
cytokines and oxidative stress, Am J Clin Nutr, 85; 837-44
(2007)
(2) Cakman I, Kirchner H, Rink LJ, Zinc supplementation
reconstitutes the production of interferon-alpha by leukocytes from
elderly persons, Interferon Cytokine Res. 1997
Aug;17(8):469-72.
(3) CDC, National Vital Statistics Report, Vol. 50, No. 15
(2002)
SOURCE Adeona Pharmaceuticals, Inc.