ROCKVILLE, Md., April 14, 2014 Synthetic Biologics, Inc. (NYSE MKT: SYN), a developer of novel anti-infective biologic and drug candidates targeting specific pathogens that cause serious infections and other diseases,announced today the formation of a Clinical Advisory Board (CAB) to support development of the Company's constipation-predominant irritable bowel syndrome (C-IBS) program. The Company also announced that pioneering gastroenterologist and lead investigator for the C-IBS program, Mark Pimentel, M.D., FRCP(C), of Cedars-Sinai Medical Center (CSMC), has joined Synthetic Biologics as Chairman of the newly formed CAB.
Dr. Pimentel led the investigational team whose discoveries established the foundation of Synthetic Biologics' C-IBS program, specifically that the production of methane gas by certain pathogenic gastrointestinal microorganisms are perceived as the underlying cause of gas, pain and constipation associated with C-IBS. Based on this discovery, Synthetic Biologics is developing an oral treatment to reduce the impact of methane producing organisms on conditions such as C-IBS. The C-IBS CAB will provide valuable expertise and clinical guidance regarding the ongoing development of the C-IBS program, which is anticipated to initiate Phase II clinical trials during the second half of 2014. Synthetic Biologics and Dr. Pimentel will seek to grow the CAB by adding prominent thought leaders and researchers as the Company prepares for clinical development.
"Throughout his career, Dr. Pimentel has been at the forefront of IBS research, having contributed significantly to our current understanding of the disease. It was for this reason that we forged our exclusive agreement with Cedars-Sinai in late 2013, and it is why we are proud to have him as the first member and Chairman of our clinical advisory board for our C-IBS program. We look forward to his continued guidance and to the expansion of the CAB as we move toward clinical-stage development later this year," stated Jeffrey Riley, Chief Executive Officer of Synthetic Biologics.
In December 2013, Synthetic Biologics entered into a worldwide exclusive license agreement with CSMC for the right to develop products for therapeutic and prophylactic treatments for acute and chronic diseases. The investigational team, led by Dr. Pimentel, will focus initially on the development of an oral treatment to reduce the impact of methane producing organisms on C-IBS. The Company expects to initiate in vivo/pharmacokinetic/pharmacodynamic studies in the first half of 2014, and to initiate a Phase II clinical trial during the second half of 2014 under an Investigational New Drug (IND) application.
Dr. Mark Pimentel is an Associate Professor of Medicine at CSMC in Los Angeles, California. Dr. Pimentel completed his medical degree at the University of Manitoba and pursued a residency in internal medicine at the University of Manitoba Health Sciences Center in Winnipeg, Manitoba, Canada. His medical training includes a fellowship in gastroenterology at the UCLA Affiliated Training Program. Active in research, Dr. Pimentel has served as a principal investigator or co-investigator for numerous basic science, translational and clinical studies in such areas as IBS, and the relationship between gut flora composition and human disease. His work has been published in the New England Journal of Medicine, Annals of Internal Medicine,American Journal of Physiology, American Journal of Medicine, American Journal of Gastroenterology and Digestive Diseases and Sciences, among others. Dr. Pimentel has been invited to present his work at meetings, grand rounds, and advisory boards in the United States and Internationally. He is a diplomate of the American Board of Internal Medicine (Gastroenterology) and a fellow of the Royal College of Physicians and Surgeons of Canada. Dr. Pimentel is also a member of several medical associations including the American Gastroenterological Association, the American College of Gastroenterology, and the American Neurogastroenterology and Motility Society.
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 other diseases. The Company is developing an oral treatment to reduce the impact of methane producing organisms on constipation-predominant irritable bowel syndrome (C-IBS), 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 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 Dr. Pimentel and the CAB 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.