ANN ARBOR, Mich., Nov. 11, 2011 /PRNewswire/ -- Adeona
Pharmaceuticals, Inc. (NYSE Amex: AEN), a developer of innovative
medicines for serious central nervous system diseases, announced
that the Company's drug candidate, Trimesta™ (oral estriol), will
be utilized in a new Phase II clinical trial to evaluate its
potential therapeutic effect on cognitive dysfunction observed in
female multiple sclerosis (MS) patients. The Skirball Foundation
and Adeona have pledged to equally support this clinical trial led
by Rhonda Voskuhl, M.D., Director,
University of California, Los Angeles
(UCLA) Multiple Sclerosis Program,
Department of Neurology. The study, which focuses on cognition loss
in MS patients, also received contributions from numerous
supporters, such as the Sherak Family Fund, the Gustafson Fund, and
the Diamont family.
"At some point, 50-65 percent of MS patients will develop
problems due to cognitive loss, yet there remains no treatment to
target this profound disability. Unfortunately, loss of cognition
affects a person's ability to work and is the major reason MS
patients stop or decrease their level of work," said Dr. Voskuhl,
Principal Investigator. "We are therefore thrilled to begin this
novel clinical trial of Trimesta in which the primary endpoint is
improvement in cognition and the ultimate goal is to address an
unmet need for these patients."
This new randomized, double-blind, placebo-controlled Phase II
clinical trial is based on findings from a 10-patient, 22-month,
single-agent, crossover clinical trial conducted by Dr. Voskuhl.
The results from the crossover trial demonstrated a statistically
significant 14% improvement from baseline in Paced Auditory Serial
Addition Test (PASAT) cognitive testing scores (p = 0.04) in MS
patients after six months of Trimesta therapy. PASAT is a routine
cognitive test performed in patients with a wide variety of
neuropsychological disorders such as MS.
"We are very pleased to announce the initiation of this new
clinical trial that will evaluate our drug candidate Trimesta,"
said James S. Kuo, M.D., M.B.A.,
Adeona's CEO and President. "Results from the ongoing Phase II
relapsing-remitting MS clinical trial and this new Phase II
clinical trial for cognitive dysfunction in MS patients should
provide results within the same time frame. Expanding the clinical
development of Trimesta in the United
States to include cognitive benefit should broaden the
potential treatment options for women suffering from MS and should
increase the economic opportunity for our drug candidate."
About Trimesta™ (oral estriol)
Trimesta is Adeona's proprietary drug candidate for the
treatment of relapsing-remitting MS and for cognitive dysfunction,
both in female patients. Estriol has been approved and marketed for
more than 40 years throughout Europe and Asia for the treatment of post-menopausal hot
flashes. It has never been approved in the United States by the Food and Drug
Administration (FDA) for any indication.
On September 19, 2011, Adeona
announced that the 150th patient has been enrolled in the
randomized, double-blind, placebo-controlled, multi-center clinical
trial of its Trimesta drug candidate for relapsing-remitting MS in
women, per the original protocol. The Company also announced that
Dr. Voskuhl had received funding to continue enrollment of an
additional 10-20 patients at all 15 centers.
About Cognitive Dysfunction in Multiple Sclerosis
According to the National Multiple Sclerosis Society and the
Multiple Sclerosis Society of Canada publication, Hold that Thought!
Cognition and MS, it is fairly common for people with multiple
sclerosis to complain of problems remembering things, finding the
right words, concentrating on a task or something they are reading,
or following a conversation. These are all cognitive symptoms of
multiple sclerosis. Fifty to sixty-five percent of those affected
by multiple sclerosis have cognitive dysfunction. Despite the fact
that most symptoms are mild to moderate, they can have a
significant impact on a person's ability to normally function. The
overall cognitive dysfunction can be described as a reduction in
mental "sharpness."
The major areas of cognition that can be dysfunctional include
what are termed complex attention and executive functions.
Complex attention involves multitasking, the speed with which
information can be processed, learning and memory, and perceptual
skills; executive functions include problem solving, organizational
skills, the ability to plan, and word finding. Just as the nature,
frequency, and severity of multiple sclerosis-related physical
problems can widely vary, not all people with multiple sclerosis
will display these cognitive issues, and no two people will
experience exactly the same types or severity of problems.
About the Phase II Trimesta™ Clinical Trial for Cognitive
Dysfunction in Multiple Sclerosis
The randomized, double-blind, placebo-controlled clinical trial
of Trimesta is expected to enroll 64 relapsing-remitting or
secondary-progressive female MS patients at UCLA. Those between the ages of 18 and 50 will be
randomized 1:1 into the treatment and placebo groups. Dr. Voskuhl
will administer either oral Trimesta or a matching placebo, in
addition to any FDA-approved standard MS treatment. Each patient
will be dosed and monitored for one year after being enrolled. The
primary endpoint is better cognition scores in the Trimesta group
versus the placebo group based on PASAT cognitive testing scores.
Detailed information regarding this clinical trial, including
contact information for the clinical site, is available at
http://www.clinicaltrials.gov/ct2/show/NCT01466114.
About Adeona Pharmaceuticals, Inc.
Adeona is a pharmaceutical company focused on 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. Adeona is developing, or has partnered
the development of, drug product candidates to treat multiple
sclerosis, fibromyalgia, amyotrophic lateral sclerosis (ALS) and
Alzheimer's disease. The Company is currently preparing to make the
following products commercially available: reaZin™, a
medical food for the dietary management of zinc deficiency
associated with Alzheimer's disease, and wellZin™, a
homeopathic over-the-counter medicine for reducing the duration and
symptoms of the common cold. Adeona also operates Adeona Clinical
Laboratory, a wholly owned clinical reference laboratory that
provides a broad array of chemistry and microbiology diagnostic
tests. 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 of results for the two
studies and benefits of expanding the clinical development of
Trimesta. 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 the clinical trial
to provide desired results, our failure to successfully
commercialize a new oral therapy for cognitive dysfunction in
multiple sclerosis and other factors described in Adeona's
report on Form 10-K for the year ended December 31, 2010 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.
SOURCE Adeona Pharmaceuticals, Inc.