ANN ARBOR, Mich., Jan. 19, 2012 /PRNewswire/ -- Adeona
Pharmaceuticals, Inc. (NYSE Amex: AEN), a developer of synthetic
DNA-based therapeutics and innovative disease-modifying medicines
for serious illnesses, announced today the initiation of the Phase
II clinical trial of Trimesta™ (oral estriol) for the treatment of
cognitive dysfunction in multiple sclerosis (MS). This clinical
trial is intended to enroll 64 relapsing-remitting or
secondary-progressive female MS patients at University of California, Los Angeles (UCLA) and is being conducted at by Principal
Investigator, Rhonda Voskuhl, M.D.,
Director, UCLA Multiple Sclerosis Program, Department of Neurology.
There is currently no approved therapy for the treatment of
cognitive dysfunction in MS.
"We are very excited to initiate patient enrollment in this
novel clinical trial of Trimesta in which the primary endpoint is
improvement in cognition. Statistics show that 50-65 percent of
patients affected by MS will develop disabilities due to a
reduction in their cognitive processing speed. Despite the fact
that cognitive dysfunction is a primary source of work related
disability in MS, there remains no treatment to target this
disability," said Dr. Voskuhl, Principal Investigator. "The goal of
this trial is to address this unmet need for MS patients,
potentially improving a person's mental sharpness and ability to
continue working."
This randomized, double-blind, placebo-controlled Phase II
clinical trial is based on findings from a previously completed
10-patient, single-agent, crossover Phase I/II clinical trial
conducted by Dr. Voskuhl and colleagues at UCLA. The results from the Phase I/II trial
demonstrated a statistically significant 14% improvement from
baseline in Paced Auditory Serial Addition Test (PASAT) cognitive
testing scores in relapsing-remitting MS patients after six months
of Trimesta™ therapy (p = 0.04).[i] The PASAT is a measure of
cognitive function that assesses auditory information processing
speed and flexibility, as well as calculation ability and is widely
used in MS to measure cognitive function. Estriol has also been
shown to have neuroprotective benefits in animal models of MS, a
property not generally shared by currently approved MS
therapies.[ii]
The new Phase II clinical trial is a randomized, double-blind,
placebo-controlled trial intended to enroll 64 relapsing-remitting
or secondary-progressive female MS patients. Subjects will be
equally randomized to receive either once-daily Trimesta™ (oral
estriol) or matching placebo. The primary outcome measure is the
average change in PASAT scores at 12 months between each group.
Secondary outcome measures include relapse rates (the primary
endpoint of the ongoing Phase II clinical trial of Trimesta™ for
relapsing-remitting MS), whole brain atrophy determined by MRI and
safety. Charitable organizations have pledged to financially
support a majority of the new MS clinical trial. Detailed
information regarding this clinical trial, including contact
information for the clinical site, is available at
http://www.clinicaltrials.gov/ct2/show/NCT01466114.
In addition to the clinical trial of Trimesta for cognitive
dysfunction in MS, Trimesta™ is also the subject of a separate
ongoing 15-center Phase II, randomized, double-blind,
placebo-controlled clinical trial seeking to demonstrate Trimesta's
ability to reduce relapse rates in women with the
relapsing-remitting form of MS. With over $8
million in grant funding awarded to date, this separate
ongoing Trimesta™ clinical trial should be funded to its
completion. Additional information regarding the
relapsing-remitting multiple sclerosis clinical trial is available
at http://www.clinicaltrials.gov/ct2/show/NCT00451204.
"While our Board of Directors has strategically implemented
several actions to prioritize our focus on the emerging field of
synthetic biologics, our continued commitment to this important new
MS clinical trial, having substantial external funding, is
consistent with our mission of maintaining and building value for
our shareholders," stated Jeffrey
Riley, Adeona's Chairman of the Board.
About Trimesta™ (oral estriol)
Trimesta™ is Adeona's proprietary drug candidate for the
treatment of relapsing-remitting MS and for cognitive dysfunction
in MS, 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
symptoms. It has never been approved in the United States by the Food and Drug
Administration (FDA) for any indication.
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 Adeona Pharmaceuticals, Inc.
Adeona is a biotechnology company focused on the development of
synthetic DNA-based therapeutics and innovative disease-modifying
medicines for serious illnesses. Adeona is developing, or has
partnered the development of, product candidates to treat pulmonary
arterial hypertension, relapses in multiple sclerosis, cognitive
dysfunction in multiple sclerosis, fibromyalgia and amyotrophic
lateral sclerosis (ALS). For more information, please visit
Adeona's website at www.adeonapharma.com.
In December 2011, Adeona announced
that the Board of Directors had taken several actions to prioritize
the company's focus on its recent entry into the emerging field of
synthetic biologics. As a result of its new primary focus, the
Board approved a proposed name change of the company to Synthetic
Biologics, Inc., to better reflect its new mission and primary
business. Such name change is subject to stockholder approval.
Synthetic Biologics is a trademark of Adeona Pharmaceuticals,
Inc.
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 intended enrollment of the
Phase II clinical trial for cognitive dysfunction in multiple
sclerosis, the potential results of the trial and the funding for
the 15-center relapses in multiple sclerosis clinical 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 intended enrollment, 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, an inability to
complete the trials with the current funding 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.
For further information, please contact Adeona at (734)
332-7800, Ext. 22.
[i] Sicotte, Liva, Klutch, Pfeiffer, Bouvier, Odesa, Wu,
Voskuhl, Treatment of multiple sclerosis with the pregnancy hormone
estriol, Ann Neurol. 2002 Oct;52(4):421-8.
[ii] Gold and Voskuhl, Estrogen treatment in multiple sclerosis,
J Neurol Sci. 2009 Nov 15;286(1-2):99-103. Epub 2009 Jun 18.
SOURCE Adeona Pharmaceuticals, Inc.