ANN ARBOR, Mich., March 14, 2012 /PRNewswire/ -- Synthetic
Biologics, Inc. (NYSE Amex: SYN), a developer of synthetic
DNA-based therapeutics and innovative disease-modifying medicines
for serious illnesses, announced today that patient enrollment has
been completed in a Phase II clinical trial evaluating the efficacy
and safety of Synthetic Biologics' proprietary oral formulation of
estriol (Trimesta™) for the treatment of relapsing-remitting
multiple sclerosis (MS). With over $8
million in external grant funding awarded to date, this
Trimesta clinical trial should be fully funded to its
completion.
"The completion of patient enrollment into the Phase II Trimesta
trial represents another important milestone for oral estriol and
brings us one step closer to offering a new oral treatment option
to patients with relapsing-remitting MS," said Jeffrey Riley, Chief Executive Officer of
Synthetic Biologics. "As an oral therapy with a promising clinical
profile, Trimesta is expected to be extremely well positioned to
provide an important treatment option for this debilitating
disease."
The randomized, double-blind, placebo-controlled, multi-center
Phase II clinical trial of Trimesta (oral estriol) for
relapsing-remitting MS in women initially enrolled a total of 164
patients. At 15 sites in the United
States, clinical investigators have been administering
either oral Trimesta or matching placebo in addition to glatiramer
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. MS patients are being dosed and monitored
for two years. The primary outcome measure for the study is the
rate of relapse between the placebo and treated groups at two
years, an accepted FDA-approvable endpoint in MS. Additional
information regarding the relapsing-remitting MS clinical trial is
available at
http://www.clinicaltrials.gov/ct2/show/NCT00451204.
Current sales of injectable disease-modifying therapies for MS
are estimated at $8.9 billion
annually. According to various reports, sales of oral
disease-modifying therapies for MS, of which Trimesta™ if and when
approved would be in such class, are anticipated to exceed
$5 billion annually by 2017.
"We are pleased to complete the enrollment of a total of 164
patients in this landmark MS trial," said Rhonda Voskuhl, M.D., Director, University of California, Los Angeles (UCLA) Multiple Sclerosis Program, UCLA Department
of Neurology, and lead Principal Investigator of the trial. "In
the United States alone, over 200
people per week are diagnosed with MS, and approximately 70% of
them are women. Typically, relapsing-remitting MS is distinguished
from the other forms of MS by the relapses, or attacks of declining
neurologic function, followed by periods of remission. With this
trial evaluating oral estriol (Trimesta), we would expect to
demonstrate a reduction in the rate of relapses in these MS
patients."
About Trimesta (oral estriol)
Trimesta is Synthetic Biologics' 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. Dr. Voskuhl 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 Synthetic Biologics, Inc.
Synthetic Biologics is a biotechnology company focused on the
development of synthetic DNA-based therapeutics and innovative
disease-modifying medicines for serious illnesses. Synthetic
Biologics is developing, or has partnered the development of,
product candidates for the treatment of pulmonary arterial
hypertension, relapsing-remitting multiple sclerosis, cognitive
dysfunction in multiple sclerosis, fibromyalgia and amyotrophic
lateral sclerosis (ALS). For more information, please visit
Synthetic Biologics' website at www.syntheticbiologics.com.
This release includes forward-looking statements on Synthetic
Biologics' 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 Trimesta
as a treatment option for MS, the statements regarding the
estimates of the potential market for oral disease-modifying
therapies for MS, the expected results of the clinical study and
adequacy of funding. 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 Synthetic Biologics'
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 Synthetic
Biologics' 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 Synthetic Biologics 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 Synthetic Biologics, Inc.