ANN ARBOR, Mich., July 6 /PRNewswire-FirstCall/ -- Adeona
Pharmaceuticals, Inc., (AMEX: AEN) announced today that on
July 6, 2010, it completed an equity
financing of $1 million with a single
institutional investor, Seaside 88, L.P. The financing
involved the sale of 1,212,121 registered shares of common stock
and no warrants. Enclave Capital served as placement agent
and will receive a 7% cash commission and 5-year warrants to
acquire 60,606 shares of Adeona at $1.32 per share. The use of proceeds is
intended for general corporate purposes.
Separately, Adeona announced the completion of 75% enrollment in
Part 2 of Adeona's 60 patient clinical study of oral Zinthionein ZC
for Alzheimer's disease and mild cognitive impairment entitled, A
Prospective, Randomized, Double Blind Trial of a Novel Oral Zinc
Cysteine Preparation in Alzheimer's Disease (CopperProof-2).
For further information see,
http://clinicaltrials.gov/ct2/show/study/NCT01099332.
Adeona is also providing guidance today that it expects to
complete the CopperProof-2 clinical study and announce results in
the first quarter of 2011. If successful, Adeona and/or its
marketing partner(s) should be eligible to immediately begin
marketing Zinthionein ZC as a prescription medical food intended
for the dietary management of Alzheimer's and mild cognitive
impairment.
The CopperProof-2 study represents the first controlled clinical
study of oral zinc therapy for Alzheimer's disease and mild
cognitive impairment. Part 2 of the CopperProof-2 study is designed
as a 60-subject comparator study. Subjects are randomized on a
50:50 basis to receive either Zinthionein ZC or matching placebo.
After 3 and 6 months on clinical trial material, serum measurements
of zinc and copper are taken, and any changes in cognitive function
using standard clinical tests used in Alzheimer's disease and mild
cognitive impairment are recorded.
The completion of 75% enrollment follows Adeona's announcement
of completion of 50% enrollment less than one month ago as well as
Adeona's April 14th announcement of
positive results from Part 1 of the CopperProof-2 study. Part 1
demonstrated a substantially lower incidence of adverse effects in
Alzheimer's disease and mild cognitive impairment subjects (33%
versus 100%) in favor of Zinthionein ZC (containing 150 mg of
elemental zinc acetate and 100 mg of cysteine) compared to Galzin®
(containing either 50 mg or 100 mg of elemental zinc as zinc
acetate). Zinthionein ZC also demonstrated superior serum zinc
bioavailability in Alzheimer's disease and mild cognitive
impairment subjects compared to both the 50 mg and 100 mg dose
levels of Galzin®.
"We are very pleased to have Seaside 88 as a new investor in
Adeona. We also consider the rapid enrollment in our
CopperProof-2 clinical trial as an excellent indication of the high
clinical need for a potential disease modifying therapy in
Alzheimer's disease and mild cognitive impairment, especially one
that is convenient, tolerable and also having a substantial history
of safety. Should our CopperProof-2 study prove successful,
we believe that Zinthionein ZC is now well positioned to represent
the first commercially available disease-modifying therapy for
Alzheimer's disease and mild cognitive impairment, a multibillion
dollar market opportunity," stated James S.
Kuo, MD, MBA, Adeona's Chief Executive Officer.
Background of the CopperProof-2 Clinical Study and Zinc for
Alzheimer's Disease and Mild Cognitive Impairment
Observations by Adeona scientists and other scientists of
sub-clinical zinc deficiency in Alzheimer's disease patients(1,2)
plus a body of published literature that chronic elevated copper
exposure contributes to the progression of Alzheimer's disease and
mild cognitive impairment prompted the present CopperProof-2
clinical study. A small and uncontrolled zinc therapy study in
Alzheimer's disease patients published in 1992(3) demonstrated
cognitive improvements in 80% of subjects. In some subjects, the
improvement was detectable after only 3 months of administering
zinc. Due to significant gastrointestinal side effects associated
with oral zinc administration, the study was temporarily suspended
and injectable zinc was used to finish the study, emphasizing the
clinical utility of a convenient and well-tolerated oral zinc
therapy such as Zinthionein ZC.
Alzheimer's disease can affect the entire brain but it is
particularly associated with loss of tissue in the hippocampus, the
area in the brain responsible for several functions including
short-term memory retention and processing. The hippocampus has one
of the highest concentrations of zinc in the brain. Hippocampal
zinc is thought to play a role in hundreds of protective enzymes
and other systems, including those that detoxify amyloid beta, an
abnormally folded peptide that accumulates in aging and is a
biomarker for Alzheimer's disease. When cerebrospinal fluid zinc is
low, levels of the particularly toxic beta amyloid 42 are
elevated.(4)
Hippocampal zinc serves as a neurotransmitter, and also
modulates a specific excitatory neuroreceptor, the NMDA
(N-methyl-D-aspartic acid) receptor. If the neuroexcitation goes
uncontrolled, there is a derangement of brain tissue function, and
possibly neuronal death.(5) By elevating cerebrospinal fluid zinc,
NMDA receptor excitation may be better controlled, improving tissue
function and thereby acute cognition and tissue survival, as may
have been seen in the 1992 study. NMDA-receptor antagonists now
available for Alzheimer's, including Namenda and Axura, annually
sell an estimated $2.6 billion.
References:
1 Brewer JG, Kanzer SH, Zimmerman E, Heckman S, Newsome D. Sub-clinical zinc deficiency found in
Alzheimer's disease. Presentation P4-313, International Congress on
Alzheimer's Disease. Vienna,
Austria; July, 2009.
2 Baum L, ChanI H, Cheung SH et al. Serum zinc is decreased in
Alzheimer's disease and serum arsenic correlates positively with
cognitive ability. Biometals. 2010; 23: 173-179.
3 Constantinides J. Treatment of Alzheimer's disease by zinc
compounds. Drug Develop. Res. 1992; 27: 1-14.
4 Strozyk D, Launer LJ, Adlard PA, et al. Zinc and copper
modulate Alzheimer abeta levels in human cerebrospinal fluid.
Neurobiol. Aging. 2009; 30: 1069-1077.
5 Izumi Y, Auberson YP, Zorumski CF. Zinc modulates
bidirectional hippocampal plasticity by effects on NMDA receptors.
J Neurosci. 2006; 26(27): 7181-7188.
About Zinthionein ZC
Zinthionein ZC is a once-daily, gastroretentive,
sustained-release, oral tablet formulation of zinc and cysteine.
Zinc, an essential nutrient, participates as a necessary factor in
the activity of over 200 enzymes and the DNA binding capacity of
over 400 nuclear regulatory elements. Zinc may also directly
participate in antioxidant protection by reducing the
susceptibility of sulfhydril groups to damage by oxidative free
radicals. Cysteine is an amino acid that has potent anti-oxidant
properties and is a necessary component of the copper/zinc-binding
protein, metallothionein. Zinthionein ZC was invented and
developed by Adeona scientists to achieve the convenience of
once-daily dosing, high oral bioavailability and to minimize
gastrointestinal side effects associated with other commercially
available, oral zinc products. All of Zinthionein ZC's constituents
have GRAS (Generally Regarded as Safe) status. Adeona is developing
Zinthionein ZC as a prescription medical food for the dietary
management of Alzheimer's disease and mild cognitive impairment.
Zinthionein ZC is protected by multiple U.S. and international
pending patent applications held by Adeona.
About Adeona Pharmaceuticals, Inc.
Adeona (AMEX: AEN) is a pharmaceutical company developing new
medicines for serious central nervous systems diseases. Adeona's
primary strategy is to in-license clinical-stage drug candidates
that have already demonstrated a certain level of clinical efficacy
and develop them to an inflection point in valuation resulting in a
significant development and marketing collaboration. Trimesta
(estriol) is an investigational oral drug for the treatment of
relapsing remitting multiple sclerosis. A 150-patient, 16-center,
randomized, double-blind, placebo-controlled clinical trial is
currently underway. Effirma (flupirtine) is a centrally-acting
investigational oral drug for the treatment of fibromyalgia
syndrome. Adeona has entered into a potential $17.5 million corporate partnership with Meda AB.
As part of the agreement, Meda will assume all future development
costs while Adeona is entitled to receive milestone payments and
royalties. Zinthionein ZC (zinc cysteine) is an oral,
gastro-retentive, sustained-release medical food candidate being
developed for the dietary management of Alzheimer's disease and
mild cognitive impairment. A 60-patient randomized double-blind,
placebo-controlled clinical study is currently underway. dnaJP1
(hsp peptide) is an investigational oral drug for the treatment of
rheumatoid arthritis. It has completed a 160-patient, multi-center,
randomized, double-blind, placebo-controlled clinical trial.
ZincMonoCysteine (zinc-monocysteine) is an investigational oral
drug for the treatment of dry age-related macular degeneration. It
has completed an 80-patient, randomized, double-blind,
placebo-controlled clinical trial. Further information on the
company is available 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 expected completion date of the
oral Zinthionein clinical trial and results of the trial. 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 to complete the trial when anticipated, a
failure of the trial to achieve desired results or a failure 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. Zinthionein ZC ™ is a trademark of Adeona and Galzin® is a
registered trademark of Gate Pharmaceuticals, Inc.
SOURCE Adeona Pharmaceuticals, Inc.