ROCKVILLE, Md., July 31, 2014 /PRNewswire/ -- Synthetic
Biologics, Inc. (NYSE MKT: SYN), a biotechnology company developing
novel anti-infective biologic and drug candidates targeting
specific pathogens that cause serious infections and diseases,
announced today that Rhonda Voskuhl,
M.D., the lead investigator of the Phase II clinical trial
evaluating Trimesta™, the Company's oral
product candidate for the treatment of relapsing-remitting multiple
sclerosis (MS), is scheduled to present additional clinical outcome
data, including more detailed results on cognitive and disability
measures. The data will be presented at the 2014 Joint Americas and
European Committees for Treatment and Research in Multiple
Sclerosis Meeting (ACTRIMS-ECTRIMS) in Boston.
The abstract titled, A Combination Trial of Estriol Plus
Glatiramer Acetate in Relapsing-Remitting Multiple Sclerosis:
Effects on Disabilities, will be featured in an oral
presentation on Friday, September 12,
2014, at 8:39am (ET).
"We are thrilled that Dr. Voskuhl will present additional
clinical findings for Trimesta, an oral agent for treating MS in
women. The presentation provides further data on the Phase II
topline efficacy results reported in April
2014, comparing Trimesta in combination with
Copaxone® to Copaxone® alone as an active
control arm. The presentation is expected to provide details about
the significant clinical outcome measures including relapse rate,
disability, and cognition measures evaluated in this compelling
trial," stated Jeffrey Riley, Chief
Executive Officer of Synthetic Biologics. "If the findings are
supported in further studies, Trimesta, either alone or in
combination with other MS drugs, could become a leading front-line
therapy for women with MS due to its unique and differentiated
anti-inflammatory, as well as neuroprotective benefits."
Dr. Voskuhl commented, "The clinically significant improvement
in cognitive testing in women taking Trimesta in this Phase II
study is of high importance for MS specialists and patients. We
believe the differentiated mechanism of action observed with
Trimesta presents a new oral opportunity and has the potential to
be an ideal added oral therapy to address significant unmet needs
for women affected by this progressive, debilitating
condition."
About Trimesta
Trimesta™ (oral estriol) is Synthetic
Biologics' investigational drug being evaluated in combination with
Copaxone® (glatiramer acetate injection) in an
investigator-initiated, 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 15 other U.S. centers, administered either
Trimesta (8 milligrams orally per day) plus Copaxone®
(20 milligrams per day), or placebo plus Copaxone® to
patients randomized in the trial. This investigator-initiated
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 novel anti-infective biologic
and drug candidates targeting specific pathogens that cause serious
infections and diseases. The Company is developing an oral biologic
to protect the gastrointestinal microflora from the effects of IV
antibiotics for the prevention of Clostridium difficile (C.
difficile) infection, an oral treatment to reduce the impact of
methane producing organisms on constipation-predominant irritable
bowel syndrome (C-IBS), a series of monoclonal antibodies for the
treatment of Pertussis and Acinetobacter infections, and a
biologic targeted at the prevention and treatment of a root cause
of a subset of IBS. In addition, the Company is developing an oral
estriol drug 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.
Copaxone® is a registered trademark of Teva
Pharmaceutical Industries Ltd.
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 potential benefits
of Trimesta for patients with MS, the ability of Trimesta either
alone or in combination with other MS drugs,
could become a leading front-line therapy for women and
the belief that Trimesta presents a new oral opportunity and has
potential to be an ideal added therapy to address
significant unmet needs for women with MS. 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 additional clinical 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, 2013 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.
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SOURCE Synthetic Biologics, Inc.