— Mark Pimentel, M.D., FRCP(C), of Cedars-Sinai Medical Center Serves as Chairman —
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.therivabio.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.
SOURCE Synthetic Biologics, Inc.
Released October 15, 2014