ROCKVILLE, Md., Oct. 15, 2014 /PRNewswire/ -- Synthetic
Biologics, Inc. (NYSE MKT: SYN), a biotechnology company developing
novel anti-infective biologics and drugs targeting specific
pathogens that cause serious infections and
diseases, announced today the expansion of its Clinical
Advisory Board (CAB) created to support development of SYN-010, the
Company's statin-class candidate intended to reduce the impact of
methane producing organisms on constipation-predominant irritable
bowel syndrome (C-IBS).
The C-IBS CAB, chaired by Mark
Pimentel, M.D., Director of the GI Motility Program and
Laboratory at Cedars-Sinai Medical Center, is strengthened by the
addition of four new members. The valuable guidance provided by the
C-IBS CAB has focused the clinical development of SYN-010, which is
anticipated to initiate a Phase II clinical trial in C-IBS during
the first half of 2015 under a corporate Investigational New Drug
(IND) application, with topline data expected in mid-2015.
Jeffrey Riley, Chief Executive
Officer of Synthetic Biologics, stated, "We look forward to the
contribution these seasoned experts can add to our strategy for
SYN-010, as we prepare to enter advanced clinical trials early next
year. Each new advisor brings broad experience and knowledge in the
GI field to Synthetic Biologics, which should be instrumental in
our continued development of SYN-010."
William Chey, M.D., is a
Professor of Medicine, Director of the GI Physiology Laboratory,
and Co-Director of the Michigan Bowel Control Program at the
University of Michigan. Dr. Chey's
clinical and research interests include: diagnosis and treatment of
irritable bowel syndrome (IBS), constipation, fecal incontinence;
gastroesophageal reflux disease (GERD), and "H. pylori"
infection. Dr. Chey received his medical degree and training in
internal medicine from Emory University School
of Medicine and went on to complete a fellowship in
gastroenterology at the University of Michigan
in Ann Arbor, remaining with the University for his academic
career. The author of more than 250 manuscripts, reviews, and book
chapters, Dr. Chey serves on the editorial boards of several
medical journals in the field of gastroenterology. He is
Co-Editor-in-Chief of the American Journal of
Gastroenterology and of Clinical & Translational
Gastroenterology.
Gail M. Comer, M.D., a
board-certified gastroenterologist and hepatologist, has more than
16 years of experience in the pharmaceutical industry, having spent
seven years at Abbott Laboratories as a Medical Director, six years
in clinical development at Wyeth Research as Senior Medical
Director, Senior Director of the BioTherapeutics Research Unit at
Pfizer. She also served as the Chief Medical Officer at Synergy
Pharmaceuticals before starting her own consulting business.
Throughout her career in the pharmaceutical industry Dr. Comer has
focused primarily on gastrointestinal and inflammatory disorders.
Dr. Comer was an Associate Professor of Clinical Medicine and
Director of Endoscopy at The State University
of New York at Stony Brook
prior to joining the pharmaceutical industry.
Anthony J. Lembo, M.D., is
Associate Professor of Medicine at Harvard
Medical School. He also serves as the Director of the GI
Motility Laboratory at the Beth Israel Deaconess Medical Center's
(BIDMC) Division of Gastroenterology in Boston, MA. Dr. Lembo earned his undergraduate
degree in Mathematics at Amherst
College and his MD from Tufts Medical
School. He subsequently completed his Internal Medicine
Internship/Residency as well as Gastroenterology Fellowship at UCLA
Medical Center in Los Angeles, CA.
Following his fellowship he joined the faculty at UCLA Medical
Center where he was Co-Director of the Functional Bowel Disorders
and GI Motility Center. In 1997 he joined the faculty at BIDMC. Dr.
Lembo is actively researching the role of placebo in functional
bowel disorders such as IBS and chronic constipation.
Philip Schoenfeld, M.D., MSEd,
MSc, is Professor of Medicine at the University of Michigan School of Medicine, Director
of the University's Gastrointestinal Epidemiology Training Program,
and staff physician in UM's Specialized Functional Bowel Disorder
Program. He completed his M.D. and Master's Degree in Medical
Education at the University of
Pennsylvania School of Medicine, and completed his Master of
Science in clinical epidemiology at McMaster
University School of Medicine. After completing his internal
medicine residency at Naval Medical Center, Portsmouth, VA, he completed his
gastroenterology fellowship at National Naval Medical Center,
Bethesda, MD. He is currently
Associate Editor of Gastroenterology, past Associate Editor
(Colon) for the American Journal of Gastroenterology, past
Chair of the AGA's Education Committee, past Chair of the AGA's
Clinical Practice Section. Dr. Schoenfeld's research focuses on
novel treatments for irritable bowel syndrome and quality
improvement in colonoscopy. He has co-authored the American College
of Gastroenterology (ACG) Evidence-Based Position Statement on
Management of Irritable Bowel Syndrome, ACG Evidence-Based Position
Statement on Management of Chronic Constipation, ACG Guideline on
Colon Cancer Screening, and ASGE/ACG Position Statement on Quality
Indicators in Colonoscopy.
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.
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 new CAB members, the anticipated
initiation of a Phase II clinical trial in C-IBS during the first
half of 2015 under a corporate IND application and the topline data
expected in mid-2015. 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 CAB 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.