ROCKVILLE, Md., June 30, 2014 /PRNewswire/ -- Synthetic
Biologics, Inc. (NYSE MKT: SYN), a developer of novel
anti-infective biologic and drug candidates targeting specific
pathogens that cause serious infections and
diseases, announced today the formation of a Clinical
Advisory Board (CAB) to support development of SYN-004, the
Company's lead anti-infective product candidate for the prevention
of the devastating effects of Clostridium difficile (C.
difficile). The new CAB is comprised of industry leaders
Mark Wilcox, M.D., (Chairman),
Curtis Donskey, M.D., Ciarán Kelly,
M.D. and Tom Louie, M.D., all of
whom will provide expertise and guidance on each aspect of the
C. diff clinical program.
SYN-004 has the potential to protect the gut microbiome from the
effects of IV beta-lactam antibiotics for the prevention of C.
difficile infection. Synthetic Biologics expects to initiate
Phase Ia and Ib clinical trials to evaluate SYN-004 in the second
half of 2014, with preliminary topline data expected by year-end
2014. A Phase II efficacy study of SYN-004 is expected to begin in
the first half of 2015.
"As we move closer to initiating human clinical trials of
SYN-004, and build our global leadership position in the C.
difficile prevention space, we are pleased to assemble this
group of highly experienced and knowledgeable advisors to guide
clinical development of our program," stated Jeffrey Riley, Chief Executive Officer of
Synthetic Biologics. "Synthetic Biologics' new CAB combines some of
the strongest collective expertise in the C. difficile area,
and we should benefit greatly from its insight and guidance as we
move toward the clinic."
"I'm pleased to chair Synthetic Biologics' C. difficile
CAB," said Dr. Wilcox. "SYN-004 has the potential to have a
significant impact on mitigating this urgent public health threat,
and I look forward to working with the other advisory board members
to help the Company move this promising program forward as
expeditiously and strategically as possible."
Professor Mark Wilcox M.D.,
FRCPath, is a Consultant Microbiologist, Head of Microbiology and
Academic Lead of Pathology at the Leeds Teaching Hospitals (LTHT),
Professor of Medical Microbiology at the University of Leeds at
their Institute of Biomedical and Clinical Sciences, and is the
lead on Clostridium difficile for Public Health England in
the UK. He was formerly the Director of Infection Prevention,
Infection Control Doctor and Clinical Director of Pathology at
LTHT. Dr. Wilcox is deputy Chair of the UK Department of Health's
Antimicrobial Resistance and Healthcare Associated Infection
Committee and is a member of the HPA's Program Board on Healthcare
Associated Infection & Antimicrobial Resistance. He has a track
record of translational research, including providing the basis of
clinical advice to the NHS. He has been the Principal/UK
Investigator for several clinical trials of new anti-infective
drugs and has provided clinical advice as part of the FDA/EMA
submissions for the approval of several novel antimicrobial
agents.
Curtis Donskey, M.D., is
Associate Professor of Medicine at Case
Western Reserve University School of Medicine, as well as
Chairman of the Infection Control Committee at the Louis Stokes
Cleveland Veterans' Affairs Medical Center. His expertise and
research focus includes the epidemiology and transmission of C.
difficile infections in the elderly and in nursing home
populations, as well as the infection control issues of antibiotic
use. Dr. Donskey has moderated a number of national conferences on
the epidemiology of C. difficile.
Ciarán P. Kelly, M.D., is Professor of medicine at Harvard Medical School, as well as Director of
Gastroenterology Fellowship Training and Medical Director of the
Celiac Center at Beth Israel Deaconess Medical Center in
Boston, MA. Dr. Kelly has
longstanding clinical and research interests into the causes,
diagnosis and treatment of Clostridium difficile infection,
and he leads NIH-funded research on C. difficile colitis.
Dr. Kelly has authored numerous clinical and basic research book
chapters, invited reviews, and more than 100 peer-reviewed
publications appearing in such journals as Infection &
Immunity, American Journal of Physiology, Gastroenterology, Journal
of Biological Chemistry, Journal of Clinical Investigation, The
Lancet and New England Journal of Medicine.
Thomas Louie, M.D., is Professor
of Medicine in the department of medicine and
microbiology-immunology & infectious diseases at the
University of Calgary in Alberta, Canada. He also serves as Infection
Prevention & Control officer at Alberta Health Services, and
was the Medical Director of the infection prevention and control
program in the Calgary Health Region 1998-2013. He is involved in
clinical trials of new antimicrobial agents primarily for the
treatment of C. difficile infection. His research interests
include the ecology of hospital-acquired infections in patients
receiving antibiotics, and studies on the role of the gut
microflora and its replacement by fecal transplantation for the
treatment of recurrent C. difficile infection, and possible
roles for the prevention of other nosocomial infections.
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
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.
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
contribution of the CAB members, the potential for SYN -004 and the
timing of the clinical trials. 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 initiate trials within the
anticipated time frame, the ability to successfully
integrate the clinical advisory board members 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.
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SOURCE Synthetic Biologics, Inc.