ROCKVILLE, Md., Feb. 10, 2014 /PRNewswire/ -- Synthetic
Biologics, Inc. (NYSE MKT: SYN), a developer of product candidates
focused on the prevention and treatment of serious infectious and
other diseases, announced today that Rhonda
Voskuhl, M.D., the lead investigator of the Phase II
clinical trial evaluating the Company's oral estriol product
candidate, Trimesta™, for the treatment of relapsing-remitting
multiple sclerosis (MS), will present topline results at the
American Academy of Neurology's (AAN) 66th Annual
Meeting in Philadelphia. The
abstract titled, A Combination Trial of Estriol Plus Glatiramer
Acetate in Relapsing-Remitting Multiple Sclerosis, will be
presented as part of the AAN Emerging Science program during two
sessions, as follows:
MS and CNS Inflammatory Disease: Novel
Therapeutics
Presentation: 003
Event Date: Tuesday, April 29,
2014
Presentation Time: 3:45 p.m. (ET)
Emerging Therapeutic Advances in Multiple
Sclerosis
Presentation: 002
Event Date: Wednesday, April 30,
2014
Presentation Time: 5:35 p.m. (ET)
Trimesta™ (oral estriol) is being evaluated in combination
with Copaxone® (glatiramer acetate injection) in a randomized,
double-blind, placebo-controlled Phase II clinical trial for the
treatment of relapsing-remitting MS in women. Lead Principal
investigator, Rhonda Voskuhl, M.D.,
Professor, Department of Neurology, Jack H. Skirball Chair in
Multiple Sclerosis Research and Director, Multiple Sclerosis
Program at University of California, Los
Angeles (UCLA) School of
Medicine, along with investigators at 14 other U.S. centers,
administered either Trimesta™ (8 milligrams orally per day) in
combination with Copaxone® (20 milligrams per day), or a placebo
plus Copaxone® to patients randomized in the trial.
Patients in this Phase II relapsing-remitting MS trial completed
their final 24-month visit during January
2014. The primary outcome measure for the study is the
annualized rate of relapse between the placebo and treated groups,
an accepted FDA-approvable endpoint in MS. The clinical trial is
supported by grants exceeding $8
million, awarded primarily by the National Multiple
Sclerosis Society (NMSS) in partnership with the NMSS's
Southern California chapter, and
the National Institutes of Health.
About Multiple Sclerosis
MS is a progressive neurological disease in which the body loses
the ability to transmit messages along central nervous system nerve
cells, leading to pain, loss of muscle control, paralysis,
cognitive impairment and in some cases death. According to the
NMSS, more than 2.3 million people worldwide (approximately 400,000
patients in the U.S., of which approximately 65% are women) have
been diagnosed with MS. The diagnosis is typically made in young
adults, ages 20 to 50. According to the NMSS, approximately 85% of
MS patients are initially diagnosed with the relapsing-remitting
form, and 10-15% with other progressive forms. Annual worldwide
sales of current MS therapies are estimated at $14.1 billion.[i]
About Synthetic Biologics, Inc.
Synthetic Biologics, Inc. (NYSE MKT: SYN) is a biotechnology
company focused on the development of product candidates for
serious infectious and other diseases. Synthetic Biologics is
developing oral treatments targeting archaea, a non-bacterial
intestinal form of life increasingly associated with chronic
diseases such as irritable bowel syndrome (IBS), obesity and type 2
diabetes, an oral biologic to protect the gastrointestinal
microflora from the effects of IV antibiotics for the prevention of
C. diff infection, a series of monoclonal antibodies (mAbs)
for the treatment of Pertussis and Acinetobacter infections,
and a biologic targeted at the prevention and treatment of IBS. In
addition, the Company is developing an oral estriol drug candidate
for the treatment of relapsing-remitting multiple sclerosis (MS)
and cognitive dysfunction in MS. 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," "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 expected impact of
the trial results. 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, the announced
results of the trial not meeting our expectations and other factors
described in Synthetic Biologics' report on Form 10-K for the year
ended December 31, 2012 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.
[i] Credit Suisse. Multiple Sclerosis-Evolution or Revolution
Report. March 18, 2013.
SOURCE Synthetic Biologics, Inc.