ANN ARBOR, Mich., Sept. 19, 2011 /PRNewswire/ -- Adeona
Pharmaceuticals, Inc. (AMEX: AEN), a developer of innovative
medicines for serious central nervous system diseases, announced
today that the 150th patient has been enrolled in the randomized,
double-blind, placebo-controlled, multi-center clinical trial of
its Trimesta™ (oral estriol) drug candidate for relapsing-remitting
multiple sclerosis (MS) in women, per the original protocol. The
Company also announced that Rhonda
Voskuhl, M.D., Director, University of
California, Los Angeles (UCLA)
Multiple Sclerosis Program, UCLA Department of Neurology, and lead
Principal Investigator of this Phase II clinical trial, has funding
available to continue enrollment at all 15 centers, therefore,
increasing the power of the trial. It is anticipated that the
remaining grant funding will allow for the enrollment of an
additional 10-20 patients.
"We are excited to announce the enrollment of the 150th MS
patient in this clinical trial, achieving our original targeted
goal for enrollment. I am also very pleased that we have funds
available to continue enrolling additional patients in this
landmark MS trial," said Dr. Voskuhl. "Of the 400,000 people in the
U.S. afflicted with MS, approximately 85% are initially diagnosed
with relapsing-remitting MS, which is characterized by relapses, or
attacks of declining neurologic function, followed by periods of
remission. As we continue to dose and monitor each MS patient
enrolled in the trial over a two year period, we would expect to
demonstrate a statistically significant reduction in the rate of
relapses in the patients treated with oral Trimesta."
"Completing enrollment in the Trimesta MS clinical trial as
originally prescribed in the protocol is a significant milestone
for Adeona and for MS patients, as it brings us one step closer to
a potential treatment for women suffering from this devastating
disease," stated James S. Kuo, M.D.,
M.B.A., Adeona's Chairman and CEO. "Once all of the patients have
been enrolled and dosed for two years, we look forward to
announcing Dr. Voskuhl's top-line results, and if positive, we
would expect to seek FDA guidance on filing a New Drug
Application."
About Trimesta (oral estriol)
Trimesta (oral estriol) is Adeona's proprietary drug candidate
for the treatment of relapsing-remitting MS in women. Estriol has
been approved and marketed for over 40 years throughout
Europe and Asia for the treatment of post-menopausal hot
flashes. It has never been approved by the FDA for any indication
in the United States.
It has been scientifically documented that pregnant women with
certain autoimmune diseases experience a spontaneous reduction of
disease symptoms during pregnancy, particularly in the third
trimester. The PRIMS (Pregnancy In Multiple Sclerosis) study, a
landmark clinical study published in the New England Journal of
Medicine followed 254 women with MS during 269 pregnancies, and
for up to one year after delivery. The PRIMS study demonstrated
that relapse rates were significantly reduced by 71 percent (p <
0.001) through the third trimester of pregnancy compared to
pre-pregnancy-rates, and that relapse rates increased by 120
percent (p < 0.001) during the first three months after birth
(post-partum) before returning to pre-pregnancy rates.
It has been hypothesized that the female hormone, estriol,
produced by the placenta during pregnancy, plays a role
in "fetal immune privilege," a process that prevents a
mother's immune system from attacking and rejecting her fetus.
Maternal levels of estriol increase in a linear fashion through the
third trimester of pregnancy until birth, whereupon they abruptly
return to low circulating levels. The anti-autoimmune effects of
estriol may also be responsible for the beneficial effects of
pregnancy on MS.
Rhonda Voskuhl, M.D., has found
that levels of estriol equivalent to pregnancy have potent
immunomodulatory effects on MS. She has further shown in a small
number of non-pregnant female MS patients that estriol may have a
therapeutic benefit by regulating the immune system and thus
reducing the relapse rates, similar to the response seen in MS
patients during pregnancy.
About the Phase II Trimesta Clinical Trial for
Relapsing-Remitting Multiple Sclerosis
The randomized, double-blind, placebo-controlled clinical trial
of Trimesta has enrolled the original target of 150 patients and
will continue to enroll patients at 15 centers in the United States. Investigators are
administering either Trimesta or matching placebo in addition to
glatimer acetate (Copaxone®), an FDA-approved therapy for MS, to
women between the ages of 18-50 who have been recently diagnosed
with relapsing-remitting MS. Each MS patient will be dosed and
monitored for two years after being enrolled in the clinical trial.
With over $8 million in grant funding
awarded to date, the ongoing Trimesta clinical trial should be
funded to its completion. Additional information regarding this
multiple sclerosis clinical trial is available at
http://www.clinicaltrials.gov/ct2/show/NCT00451204.
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
prescription 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," "could," "potential," "positions," "continue,"
"expects," "anticipates," "intends," "plans," "believe,"
"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 expected results of
the clinical study, the anticipated use of funding and adequacy of
funding and any expected FDA guidance with respect to filing a New
Drug Application. 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, our failure to successfully
commercialize a new oral therapy for multiple sclerosis, the
availability of additional financial and other resources, a
failure of our clinical trial to achieve desired results,
our failure to obtain FDA approval of oral Trimesta for the
treatment of MS 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.