Tag Archives: Synthetic Biologics

Synthetic Biologics To Participate At the 2016 RBC Capital Markets Global Healthcare Conference

2016 RBC Capital Markets Global Healthcare Conference on Tuesday, February 23, 2016
at 4:35 p.m. (ET) in the Holmes II room at the New York Palace Hotel in New York.

Synthetic Biologics, a clinical stage company focused on developing therapeutics to protect the gut microbiome, announced that Jeffrey Riley, President & Chief Executive Officer, is scheduled to participate in an analyst-led fireside chat with the Company’s covering analyst, Adnan Butt at the 2016 RBC Capital Markets Global Healthcare Conference.

A live webcast of Synthetic Biologics’ fireside chat may be accessed by logging onto the internet at https://www.veracast.com/webcasts/rbc/healthcare2016/17116241334.cfm.

After the discussion, a replay will be archived and accessible for 90 days at the same website.

SyntheticBiologics2016LOGO

About Synthetic Biologics, Inc.

Synthetic Biologics, Inc. (NYSE MKT: SYN) is a clinical stage company developing therapeutics to protect the microbiome while targeting pathogen-specific diseases. The Company’s lead candidates in Phase 2 development include:

(1) SYN-004 which is designed to protect the gut microbiome from the effects of certain commonly used intravenous (IV) antibiotics for the prevention of C. difficile infection and antibiotic-associated diarrhea (AAD),

and

(2) SYN-010 which is intended to reduce the impact of methane producing organisms in the gut microbiome to treat an underlying cause of irritable bowel syndrome with constipation (IBS-C). In collaboration with Intrexon Corporation (NYSE: XON), the Company is developing a preclinical stage monoclonal antibody for the prevention and treatment of Pertussis, and discovery stage biotherapeutics for the treatment of phenylketonuria (PKU). For more information, please visit Synthetic Biologics’ website at www.syntheticbiologics.com                                                 

 

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/synthetic-biologics-to-participate-in-fireside-chat-at-rbc-capital-markets-global-healthcare-conference-300220874.html

 

*Please note – The C Diff Foundation does not endorse this product or any product and this posting is strictly for informational purposes only.

 

Synthetic Biologics Announced Positive Topline Results From the First Phase 2a Study Of SYN-004 For C. difficile Infection Prevention

syntheticbiologics
Synthetic Biologics Announces Positive Topline Results from First Phase 2a Clinical Trial of SYN-004, the Company’s Candidate for the Prevention of C. difficile Infection

Synthetic Biologics, Inc. a clinical stage company focused on developing therapeutics to protect the gut microbiome while targeting pathogen specific diseases, announced positive topline results from the first Phase 2a study of SYN-004, the Company’s candidate designed to protect the gut microbiome from the unintended effects of certain commonly used intravenous (IV) beta-lactam antibiotics for the prevention C. difficile infection (CDI) and antibiotic-associated diarrhea (AAD). Topline results from the ten ileostomized participants who completed the Phase 2a open-label study demonstrated that SYN-004 successfully degraded residual IV ceftriaxone in the chyme (digestive fluid in the small intestine) without affecting the intended level of ceftriaxone in the bloodstream.

Evaluation of the chyme from the ileostomized participants indicates that both dosage strengths of SYN-004 (75 mg and 150 mg) degrade residual IV ceftriaxone present in the chyme, supporting the mechanism of action of SYN-004. In addition, both dosage strengths of SYN-004 appear to be well tolerated by the participants in the study. Overall, the topline data support the hypothesis that SYN-004 has the capacity to degrade residual IV ceftriaxone in the GI tract, thereby preserving the balance of the gut microbiome for the prevention of CDI, AAD and emergence of antibiotic-resistant organisms, without affecting the antibiotic level in the bloodstream intended for treatment of a primary infection.

“The completion of the first Phase 2a clinical trial for SYN-004 is an important achievement for Synthetic Biologics. These positive topline results demonstrate the potential for SYN-004 to protect the gut microbiome from the damaging effects of certain IV beta-lactam antibiotics for the prevention of C. difficile infection and antibiotic-associated diarrhea,” stated Jeffrey Riley, President and Chief Executive Officer of Synthetic Biologics. “The second Phase 2a clinical trial for SYN-004 is currently ongoing to evaluate the GI antibiotic-degrading effects and the safety of SYN-004 in the presence of the proton pump inhibitor (PPI), esomeprazole, in participants with functioning ileostomies. We anticipate reporting topline results from the second Phase 2a of SYN-004 during the first half of 2016.”

Mr. Riley concluded, “We are pleased to report additional progress from our SYN-004 program. We have begun dosing patients in the SYN-004 Phase 2b proof-of-concept clinical trial that is intended to evaluate the effectiveness of SYN-004 to prevent C. difficile infection and C. difficile associated diarrhea, as well as antibiotic-associated diarrhea in up to 370 patients hospitalized for a lower respiratory tract infection and receiving IV ceftriaxone.”

 

First SYN-004 Phase 2a Clinical Trial Design

The Phase 2a randomized, multi-center, open-label study evaluated the ability of two different dose strengths of SYN-004 to degrade residual IV ceftriaxone in the GI tract of 10 healthy participants with functioning ileostomies, without affecting the concentrations of IV ceftriaxone in the bloodstream. The study consisted of two treatment phases for all participants: 1) the administration of IV ceftriaxone alone, and 2) the administration of IV ceftriaxone with one of two dosage strengths of oral SYN-004. Chyme samples were collected from the participants to measure the capability of SYN-004 to degrade the residual antibiotic in the GI tract. Participants were enrolled at two trial sites located in Canada.

 

To read the article in its entirety click on the link below:

http://money.cnn.com/news/newsfeeds/articles/prnewswire/CL69745.htm

 

— SYN-004 Degraded IV Ceftriaxone in Gastrointestinal Tract without Affecting
Antibiotic Levels in the Bloodstream —
— First Patients Dosed in Phase 2b Proof-of-Concept Clinical Trial for SYN-004 —
— SYN to Host Microbiome Clinical Program Seminar in NYC on Thursday, December 10, 2015

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 for SYN-004 to protect the gut microbiome from the damaging effects of certain IV beta-lactam antibiotics for the prevention of C. difficile infection and antibiotic-associated diarrhea, the timing of the reporting of topline results from the second Phase 2a of SYN-004, the potential market for SYN-004, and the intended therapeutics results of SYN-004 and SYN-010. 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, a failure to receive the necessary regulatory approvals for commercialization of Synthetic Biologics’ therapeutics, a failure of Synthetic Biologics’ clinical trials, and those conducted by investigators, to be commenced or completed on time or to achieve desired results, a failure of Synthetic Biologics’ clinical trials to receive anticipated funding, a failure of Synthetic Biologics’ products for the prevention and treatment of diseases to be successfully developed or commercialized, Synthetic Biologics’ inability to maintain its licensing agreements, or a failure by Synthetic Biologics or its strategic partners to successfully commercialize products and other factors described in Synthetic Biologics’ report on Form 10-K for the year ended December 31, 2014 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  Leffler DA et al. N Engl J Med 2015; 372:1539-1548.

ii Leffler DA et al. N Engl J Med 2015; 372:1539-1548.

 

 

*Please note – The C Diff Foundation does not endorse this product or any product and this posting is strictly for informational purposes only.

 

C. difficile, a leading Healthcare-Associated Infection, Brings Together World Topic Experts At the International Raising C. diff. Awareness Conference and Health EXPO in Boston, MA on November 9th

 2015 International Raising C. diff. Awareness Conference & Health EXPO

Boston, MA, USA   ~    November 9th

7:30 a.m – 5:00 p.m

conferencesanjuanprJoin us at our 3rd annual International Raising C. diff. Awareness Conference and Health EXPO on November 9th.  Not just another educational conference but one that pairs
world-renowned topic experts with presentations on state-of-the-art health care topics pertaining to a leading Healthcare-Associated Infection (HAI); C. difficile

*Prevention
*Treatments
*Research
*Prevention and Treatment Clinical trials and studies
*Microbiome research
*Infection Prevention
*Environmental Safety
*Fecal Microbiota Restoration and Transplants
……………………..and much more.

The panel of world-renowned topic experts will also discuss the burden of C. diff. the risk factors pertaining to current and emerging treatment options along with the importance of applying evidence-based clinical approaches to the prevention of  a C. diff. infection (CDI), one of the leading Hospital-Acquired Infections.

Clostridium difficile (also known as C. diff.) is an important cause of infectious disease death in the United States.  Nearly half a million Americans suffered from Clostridium difficile (C. diff.) infections in a single year according to a study released February 25, 2015 by the Centers for Disease Control and Prevention (CDC). • More than 100,000 of these infections developed among residents of U.S. nursing homes alone.*  Approximately 29,000 patients died within 30 days of the initial diagnosis of a C. diff. infection.   Of these 29,000 – 15,000 deaths were estimated to be directly related to a  C. diff. infection. Therefore; C. diff. is an important cause of infectious disease death in the U.S.  (Source: CDC)

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Conference Venue:

Double Tree Suites Hotel – Boston – Cambridge
400 Soldiers Field Road, Boston, MA  02134  USA
1-617-783-0090 For Hotel Accommodations *   * There are hotel accommodations available for Sunday evening offered at a special event rate for guests of the C Diff Foundation.  Please inform the DoubleTree representative at the time of creating a reservation to receive the special event room rate.

Exclusive Admission:   $75.00

Student Admission:     $50.00

Each exclusive and student ticket includes admission to all presentations, formal and informal Q&A sessions, introductions to fellow healthcare professionals, continental breakfast  (7:30 a.m.) , a plated four course luncheon with the choice of Chicken Florentine or Petite Filet Mignon main entree, Access to the Health EXPO, a conference book, a educational DVD, and formal conference program.  

To Register and obtain tickets, please click on the following link

NOTE:  *Presentations should not be recorded audio or video or published without prior written and signed permission from the guest speaker and addressed by each attendee seeking publication of said presentations.

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Guest Speakers

Key Speaker and Conference Chair:  Professor Mark Wilcox;  Professor of Medical Microbiology, Leeds Institute of Biomedical and Clinical Sciences, UK. Professor Mark Wilcox is a Consultant Microbiologist, Head of Microbiology and Academic Lead of Pathology at the Leeds Teaching Hospitals, Professor of Medical Microbiology at the University of Leeds, and is the Lead on Clostridium difficile for the Public Health England. He has formerly been the Director of Infection Prevention, Infection Control Doctor and Clinical Director of Pathology at Leeds Teaching Hospitals.

Dr. John Bartlett, MD; Assistant Professor Medicine, UCLA/Sepulveda Veterans Admin Hospital 1972-5, Associate Professor and Professor of Medicine, Tufts University School of Medicine, Boston, 1975-80, Professor of Medicine and Chair Division of Infectious Diseases Division, Johns Hopkins University School of Medicine 1980 – 2006; Professor of Medicine, 2006 – 13; Professor of Medicine emeritus, Johns Hopkins University School of Medicine, 2013.Dominant research interests: anaerobic infections and pulmonary infections 1968 – 74; community acquired pneumonia and diagnostic methods, 1974-1980; Bowel prep for elective colon surgery; Protected bronchoscopy brush catheter-1977; Clostridium difficile 1977 – 84, HIV 1983 – 2014; bioterrorism 1999 –2004; Clostridium difficile infection, HIV/AIDS and antibiotic resistance 2006-2013 with  Major current interests: Clostridium difficile infection, HIV infection, antibiotic resistance, careers in infectious diseases.
Presentation Topic: “The discovery of Clostridium difficile as the cause of antibiotic-associated colitis.”

Professor Simon M. Cutting, Professor of Molecular Microbiology at Royal Holloway, University of London is a bacterial geneticist with over 25 years of experience with Bacillus since graduating from Oxford University with a D. Phil in 1986. His D.Phil was on understanding the genetic control of spore formation in Bacillus. After spending 7 years in the renowned laboratory of Professor Richard Losick at Harvard University Biological Laboratories (USA) he spent 3 years as an Assistant Professor at the University of Pennsylvania Medical School in Philadelphia. He returned to the UK in 1996 and since then has worked on developing bacterial spores as novel oral vaccines at
Royal Holloway, University of London. The Cutting lab has developed a number of prototype oral vaccines and is now entering a ‘first in man’ phase 1/IIa clinical trial of a prototype oral vaccine to 
Clostridium difficile (see www.cdvax.org). His other expertise is in the use of Bacillus spores as probiotics and has a number of contracts and consultancies with European and US companies in the food and feed sectors 
(see SporeGen.com).
Presentation Topic: “Mucosal Vaccination: Decolonisation is Essential to Full Protection Against C. difficile

Dr. Sadeq A. Quraishi, MD, MHA, MMSc   Anesthesiologist/Intensive Care physician in the Department of Anesthesia, Critical Care and Pain Medicine at the Massachusetts General Hospital in Boston, MA. He is also Assistant Professor of Anaesthesia at Harvard Medical School in Boston, MA. Dr. Quraishi’s overall research goal is to better define how macro- and micro-nutrient status influence outcomes during acute stress and critical illness. In particular, his research group has focused on the immunomodulatory effects of vitamin D in the perioperative setting, during acute care hospitalization, and for patients in the intensive care unit. Recently, Dr. Quraishi’s group has identified vitamin D status as a potentially modifiable risk factor for hospital acquired C. diff infections and that the severity of C. Diff infections may also be related to vitamin D status .
Presentation Topic:  “Vitamin D as nutritional immunomodulation
for Clostridium difficile infections.”

Dr. Mary Beth Dorr , Phd, studied Pharmacy at the University of the Sciences in Philadelphia and received a PhD in pharmacokinetics and drug metabolism from the University of North Carolina. For the last 28 years Dr. Dorr has worked in the pharmaceutical industry in various capacities, with the majority of the time devoted to the design and implementation of Phase 1 to 4 clinical trials, primarily for anti-infective products.  Prior to joining Merck, Dr. Dorr directed several large, international clinical studies of the efficacy and safety of two IV antibiotics, Synercid and dalbavancin.  She also directed clinical research programs for gastrointestinal and women’s health products.  Mary Beth joined Merck in February 2011 and is currently a Clinical Director in the Late Stage Clinical Development Department as the Clinical Monitor directing 2 large pivotal Phase 3 trials investigating the safety and efficacy of the monoclonal antibodies actoxumab and bezlotoxumab as adjunctive therapy for the prevention of C. difficile recurrence.
Presentation Topic: Bezlotoxumab for Prevention of Recurrent C. difficile Infection in Patients on Standard of Care Antibiotics:  Results of Phase 3 Trials (MODIFY I and MODIFY II)

Dr. Hudson Garrett, Jr., PhD, MSN, MPH, FNP, CSRN, VA-BC, CDONA,FACONA,DON-CLTC
Dr. Hudson Garrett is currently employed as the VP, Clinical Affairs for PDI and NIce-Pak, and is responsible for the global Clinical Affairs program and also the Medical Science Liaison program for all divisions within the company. He holds a Bachelor of Science degree in Biology/Chemistry and Nursing, a dual Masters in Nursing and Public Health, Post-Masters Certificate as a Family Nurse Practitioner, a Post-Masters Certificate in Infection Prevention and Infection Control and a PhD in Healthcare Administration and Policy. He has completed the Johns Hopkins Fellows Program in Hospital Epidemiology and Infection Control, and the CDC Fundamentals of Healthcare Epidemiology program, and is board certified in family practice, critical care, vascular assess, moderate sedation, legal nurse consulting, and a director of nursing in long term care.  Dr. Garrett is also a Fellow in the Academy of National Associations of Directors of Nursing Administration in Long Term Care.
Presentation Topic:  Preventing Clostridium difficile thru Antibiotic Stewardship

Dr. David Cook, PhD;  A scientist and entrepreneur who has held senior operating and management positions in the biotechnology industry over his 20-year career. Before joining Seres Therapeutics, he was the chief operating officer for the International AIDS Vaccine Initiative, a global R&D organization whose mission is to develop a safe, globally accessible vaccine for HIV. Prior to IAVI, David was the founding CEO at Anza Therapeutics, a biotechnology start-up developing a novel microbial vaccine platform to induce cellular immune responses to fight or prevent diseases such as cancer, hepatitis C, malaria and tuberculosis. He is also a co-inventor on over twenty-five patents. He received his undergraduate degree from Harvard College and his PhD in chemistry from the University of California, Berkeley. Dr Cook is presently Executive Vice President of R&D, Chief Scientific Officer with Seres Therapeutics, Inc.. Presentation Topic: “The role of the microbiome in resisting
C. difficile infection and the mechanism of Ecobiotic drugs.”

Julie Gubb, PhD, CIC,   has worked in the field of Infection Prevention in varying roles at healthcare facilities in multiple states for more than two decades. After graduating from the University of Detroit Mercy with a degree in Medical Technology, she began her career as Senior Clinical Microbiologist at an acute care hospital in Detroit, Michigan, where she developed an interest in Infection Control while managing the activities of a full-service microbiology laboratory. She was the Director of Infection Control at Mount Clemens Regional Medical Center in Michigan, and has also held positions in Infection Prevention at healthcare facilities in California and Nevada. As a Senior Infection Preventionist for Xenex, Julie works closely with hospitals throughout the United States to understand their infection prevention goals and develop strategies for attaining those goals. As an active member of the national organization Association for Professionals in Infection Control & Epidemiology (APIC), she has maintained Board Certification in Infection Control and Epidemiology since 1993 and speaks frequently at APIC chapter meetings.
Presentation Topic: Stand Up for Cleanliness / Enhanced Room Disinfection

Dr. Patricia J. Freda Pietrobon, PhD: Associate Vice President, R&D,
Sanofi Pasteur, has over 25 years of experience in the Vaccine & Diagnostic industries and more then 20 years in leadership roles focusing on research & development of new vaccines. Patricia began her career in diagnostic assay development with a focus on validation and quality alignment to regulatory requirements and GXPs. Patricia has been with Sanofi Pasteur for over 25 years and has contributed to the development and licensure of new bacterial & viral vaccines for pediatric & adult populations worldwide.

Barley Chironda, Manager of Infection Prevention and Control (IPAC) and Medical Device Reprocessing Device at St. Joseph Health Centre in Toronto, Canada. He is certified in Infection prevention and control (CIC TM) and has worked extensively as an Infection Preventionist. Barely has been an integral to the successful decline in Clostridium difficile infections through implementing innovative technology and quality improvement behavioral changes.   Barley’s presentation will show a behind the scenes account of the C. diff. management from the healthcare facilities perspective while providing a call to action.

Dr. Martha Clokie, PhD, Leicester UK, Professor in Microbiology.  Dr. Cloakie’s research focuses on phages that infect bacterial pathogens of medical relevance and  has published 41 papers in this area. Her major focus has been on Clostridium difficile where she has  isolated a large phage collection. In vitro and in vivo data has shown that the viruses have therapeutic potential. A patent has been filed  on these phages and  working with AmpliPhi to develop a product. Dr. Cloakie  has regular contact with the BBC and other media to talk about her work, and other phage projects, and has consulted with Science museum, London and Eden Project, UK to advise on bacteriophage displays.

Lee Jones, Founder, President and CEO of Rebiotix Inc, has over thirty years of experience in the medical technology industry in large and small companies and academia. Most recently Lee was Chief Administrative Officer of the Schulze Diabetes Institute at the University of Minnesota, Minneapolis, MN and is the former president and chief executive officer of Inlet Medical. Inlet Medical was sold to Cooper Surgical in 2006. Lee will introduce Rebiotix Inc.,  a biotechnology company founded in 2011 in Roseville, MN to revolutionize the treatment of challenging gastrointestinal diseases by harnessing the power of the human microbiome The company is developing an entirely new kind of biological drug designed to reverse pathogenic processes responsible for disease through the transplantation of live human-derived microbes into a sick person’s intestinal tract.
Presentation Topic:  Blazing a Trail with the Gut Microbiome

Professor Nancy Sheridan,   a C. diff. Survivor and  Associate Professor at the Fashion Institute of Technology and a winner of the prestigious SUNY Chancellor’s Award for Excellence in Teaching. Professor Sheridan will share her personal experience being treated for a painful and extended journey with a C. diff. infection (CDI).  Professor Sheridan has been teaching since fall 2000 in the Fashion Merchandising Management Department within the School of Business and Technology. For the past seven years, she has also taught at the University of Pennsylvania, Wharton Business School to undergraduate and MBA students.

Dr Mel Thomson, PhD,  completed her Honors degree in microbiology and immunology at the University of Melbourne . She then immigrated to the UK where she worked on various projects as diverse as allergy and cancer before undertaking further studies. She completed a Masters of Research in functional genomics before reading for a PhD in microbial genetic regulation in Neisseria species, both at University of York, UK. After the award of her PhD, Dr Thomson became interested the host-pathogen interactions at the Leeds Institute of Molecular Medicine, UK.  Dr Thomson returned to Australia in 2011 to start her own research group studying host-pathogen interactions in the GI tract, at Deakin Medical School. A passionate science communicator, and has recently become a national ‘torch bearer’ for the concept of crowd funding academic research, which a track record of three successful ‘Pozible’ crowd funding campaigns, ‘Mighty Maggots’, ‘Hips 4 Hipsters’ and ‘No more Poo Taboo’
Presentation Topic: All that glitters is C.diff awareness gold and Crowdfunding: The ‘No more poo taboo’ animation”

Dr Rahma Wehelie – LifeClean International AB – Sweden; LifeClean International AB is a Swedish company with an international orientation that conducts research, development, and production in the spore, bacteria, and virus eliminating industry. LifeClean was established in 2013 after many years of research and the headquarter lies in Uddevalla, Sweden.
Presentation Topic: Dr Wehelie will be discussing LifeClean’s research, development and production eliminating Clostridium difficile, Norovirus, and other multidrug-resistant bacteria

Dr. Klaus Gottlieb, MD, FACG,Synthetic Biologics, Inc.,Vice President, Clinical;Regulatory Affairs   Dr. Gottlieb is an experienced board-certified internist and gastroenterologist with a strong clinical science, business and drug development background. He joined Synthetic Biologics after serving as Senior Medical Director-Therapeutic Strategy Lead Gastroenterology of Quintiles, a Fortune 500 company and the world’s largest provider of biopharmaceutical development and commercial outsourcing services. At Quintiles, Dr. Gottlieb served as Global Medical Advisor for three separate large Phase 3 inflammatory bowel disease (IBD) trials and provided significant input on the shaping, design and evaluation of numerous IBD and other gastrointestinal (GI) clinical trials throughout all stages of development programs. Prior to joining Quintiles in 2013, he was with the FDA in Silver Spring, MD as a Senior Clinical Reviewer for the Division of Gastroenterology and Inborn Errors Products. Widely published, his academic contributions have been recognized by an appointment as Professor of Medicine (Clinical) at George Washington University and the following elected fellowships: Fellow American College of Physicians, Fellow American College of Gastroenterology, Fellow American Society of Gastrointestinal Endoscopy.  Presentation Topic: Protecting the Gut Microbiome

For additional information contact the C Diff Foundation: (919) 201-1512 or
info@cdifffoundation.org

To Register and obtain tickets, please click on the following link

We would like to sincerely thank the following Exclusive and Supporting Corporate Sponsors for their continued support  and joining the Foundation in
Raising C. diff. Awareness worldwide.

  • Enjoy visiting our Exclusive Corporate Sponsors websites by simply clicking on their logos belowsyntheticbiologics
  • AmericanGreenTechnologyhrmsrebiotixlogo

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uBiome-Logo (2)SporeGen Logo 2

SANOFI_Pasteur_RVBThis conference is supported through an educational grant from Sanofi Pasteur US

 

MERCKBW2015_medLogoBLK [Converted] (2)This activity has been supported by an independent patient
advocacy grant from Merck & Co., Inc.

C. difficile Clinical Trial News; Synthetic Biologics Initiates SYN-004 Phase 2b Proof-of-Concept Clinical Trial

In The News……

Study to Evaluate SYN-004’s Ability to Prevent C. difficile Infection and Antibiotic-Associated Diarrhea
Phase 2b Trial Expected to Enroll Approximately 370 Patients at up to 75 Global Clinical Sites

Synthetic Biologics, a clinical-stage company focused on developing therapeutics to protect the microbiome while targeting pathogen-specific diseases, reported the initiation of its SYN-004 Phase 2b proof-of-concept clinical trial. The clinical trial is intended to evaluate the effectiveness of SYN-004 to prevent C. difficile infection (CDI), C. difficile associated diarrhea (CDAD) and antibiotic-associated diarrhea (AAD) in patients hospitalized for a lower respiratory tract infection and receiving intravenous (IV) ceftriaxone.

C. difficile is the leading type of hospital acquired infection and is frequently associated with IV antibiotic treatment. Beta-lactam antibiotics are a mainstay in hospital infection management, and include commonly used penicillin and cephalosporin antibiotics, such as ceftriaxone. However, antibiotics have the potential to cause harmful effects within the gastrointestinal (GI) tract including disruption of the natural balance of the gut microbiome, leading to 1.1 million CDIsi and 30,000 C. difficile-related deathsii in the United States each year.

SYN-004 is Synthetic Biologics’ oral prophylactic therapy designed to degrade certain IV beta-lactam antibiotics within the GI tract and maintain the natural balance of the gut microbiome for the prevention of CDI, AAD and emergence of antibiotic-resistant organisms.

To view the SYN-004 mechanism of action video on Synthetic Biologics’
website, please click here.

“Initiating the SYN-004 Phase 2b clinical trial is an important milestone for Synthetic Biologics as it is intended to assess the proof-of-concept of SYN-004, which is designed to protect the microbiome and prevent CDIs and AAD,” stated Jeffrey Riley, Chief Executive Officer of Synthetic Biologics. “Several Phase 2b clinical sites are open for enrollment and actively screening for patients with additional sites expected to open as we approach the cold and flu season.”

Mr. Riley added, “Before initiating the SYN-004 Phase 2b clinical trial, safety and tolerability was demonstrated in two Phase 1 studies: a single-ascending dose study and a multiple-ascending dose study. Full analysis was completed and study reports were submitted to the FDA.

“In addition, our novel Phase 2a clinical trials are evaluating the GI antibiotic-degrading effects and the safety of SYN-004, both alone and in the presence of the proton pump inhibitor (PPI), esomeprazole, in participants with ileostomies (colon and rectum removed, or just part of small intestine removed). They are intended to generate additional pharmacokinetics (PK) and pharmacodynamics (PD) data to support SYN-004, and in the case of the PPI study, to analyze any potential drug-drug interactions.

“We have now enrolled enough participants to complete the first Phase 2a trial analysis, even though the recruitment of qualified ileostomized participants was slower than anticipated. We are very grateful to these at-risk participants for being a part of these studies and helping us further the development of SYN-004 for the prevention of CDIs and AAD. The Phase 2a studies are ongoing and we will report topline data from each of them when full data analysis is available. We anticipate results will be consistent with our expectations and the positive PK and safety results demonstrated in the SYN-004 Phase 1a and 1b studies previously reported in March 2015, and in the first four participants in the first Phase 2a previously reported in July 2015.”

SYN-004 Phase 2b Proof-of-Concept Clinical Trial Design

The Phase 2b, parallel-group, double-blind, placebo-controlled study of SYN-004 is expected to enroll approximately 370 patients at up to 75 global clinical sites. Patients age 50 years and older, hospitalized for a lower respiratory tract infection, are expected to be randomized 1:1 into two groups, and receive either SYN-004 or placebo during the standard of care regimen of ceftriaxone (with or without a macrolide). The primary objectives of this clinical trial are to evaluate the effectiveness of SYN-004 to prevent CDIs and CDAD. The secondary objective of this clinical trial is to evaluate the effectiveness of SYN-004 to prevent AAD.

About Synthetic Biologics, Inc.

Synthetic Biologics, Inc. (NYSE MKT: SYN) is a microbiome-focused, clinical-stage company developing therapeutics to protect the microbiome while targeting pathogen-specific diseases. The Company’s lead candidates in Phase 2 development include SYN-004 which is designed to protect the gut microbiome from the effects of certain commonly used intravenous (IV) antibiotics for the prevention of C. difficile infection and antibiotic-associated diarrhea (AAD), and SYN-010 which is intended to reduce the impact of methane producing organisms in the gut microbiome to treat the underlying cause of irritable bowel syndrome with constipation (IBS-C). In addition, the Company is developing a Phase 2 oral estriol drug for the treatment of relapsing-remitting multiple sclerosis (MS) and cognitive dysfunction in MS, and in collaboration with Intrexon Corporation (NYSE: XON), a monoclonal antibody combination for the treatment of Pertussis and biotherapeutics for the treatment of phenylketonuria (PKU). For more information, please visit Synthetic Biologics’ website at www.syntheticbiologics.com.

i This information is an estimate derived from the use of information under license from the following IMS Health Incorporated information service: CDM Hospital database for full year 2012. IMS expressly reserves all rights, including rights of copying, distribution and republication.
ii U.S. Department of Health & Human Services. Agency for Healthcare Research and Quality. January 25, 2012. http://www.ahrq.gov/news/nn/nn012512.htm Accessed: June 7. 2015.

#Cdiff2015 International Raising C. diff. Awareness Conference and Health Expo

2015 International Raising C. diff. Awareness Conference & Health EXPO

Boston, MA, USA

November 9th

8:00 a.m – 5:00 p.m

symposium

Join us at our 3rd annual International Raising C. diff. Awareness Conference and Health EXPO on November 9th as world-renown Healthcare Professionals, Researchers, and Infection Preventionists come together to share the latest data pertaining to C. difficile  infection (CDI) prevention, treatments, clinical trials, environmental safety products, Microbiome research, Healthcare-Associated Infections and much, much  more…………

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Conference Venue:

Double Tree Suites Hotel – Boston – Cambridge
400 Soldiers Field Road, Boston, MA  02134  USA
1-617-783-0090 For Hotel Accommodations *   * There are rooms available for Sunday evening and being offered at a special event rate for guests of the C Diff Foundation.  Please inform the DoubleTree representative at the time of creating a reservation to receive the special event room rate.

Registration Fee:  $75.00

Student Fee:          $50.00

Registration includes the following:   Admission to all presentations, formal and informal Q&A sessions, introductions to fellow healthcare professionals, continental breakfast, a plated luncheon with a choice of main entree  (chicken or beef) and beverages.  access to the Health EXPO exhibits, a conference book containing sponsor information, educational DVD, and a  formal conference program.  

For Tickets and Registration CLICK ON THE FOLLOWING LINK TO ACCESS THE REGISTRATION PAGE:
 

http://events.constantcontact.com/register/event?llr=6iomnjnab&oeidk=a07ebaumwu164b799f9

 

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Guest Speakers

Key Speaker and Conference Chair:  Professor Mark Wilcox, Professor of Medical Microbiology, Leeds Institute of Biomedical and Clinical Sciences, UK. Professor Mark Wilcox is a Consultant Microbiologist, Head of Microbiology and Academic Lead of Pathology at the Leeds Teaching Hospitals, Professor of Medical Microbiology at the University of Leeds, and is the Lead on Clostridium difficile for the Public Health England. He has formerly been the Director of Infection Prevention, Infection Control Doctor and Clinical Director of Pathology at Leeds Teaching Hospitals.

Dr. John Bartlett, MD; Assistant Professor Medicine, UCLA/Sepulveda Veterans Admin Hospital 1972-5, Associate Professor and Professor of Medicine, Tufts University School of Medicine, Boston, 1975-80, Professor of Medicine and Chair Division of Infectious Diseases Division, Johns Hopkins University School of Medicine 1980 – 2006; Professor of Medicine, 2006 – 13; Professor of Medicine emeritus, Johns Hopkins University School of Medicine, 2013.Dominant research interests: anaerobic infections and pulmonary infections 1968 – 74; community acquired pneumonia and diagnostic methods, 1974-1980; Bowel prep for elective colon surgery; Protected bronchoscopy brush catheter-1977; Clostridium difficile 1977 – 84, HIV 1983 – 2014; bioterrorism 1999 –2004; Clostridium difficile infection, HIV/AIDS and antibiotic resistance 2006-2013 with  Major current interests: Clostridium difficile infection, HIV infection, antibiotic resistance, careers in infectious diseases.

Professor Simon M. Cutting, is a bacterial geneticist with over 25 years of experience with Bacillus since graduating from Oxford University with a D. Phil in 1986. His work on Bacillus probiotics provides another area of research interests and he was the first to address the fundamental mechanisms that might enable these bacteria to promote potential health benefits.  Presentation Topic: CDVAX in the  prevention of C. difficile infection.”

Dr. Clifford McDonald, MD, Currently the Chief of the Prevention and Response Branch in the Division of Healthcare Quality Promotion at the Center of Disease Control (CDC).  Dr. McDonald graduated from Northwestern University Medical School, completed his Internal Medicine Residency at Michigan State University, and an Infectious Disease Fellowship at the University of South Alabama, following which he completed a fellowship in Medical Microbiology at Duke University. He is the author or co-author of over 100 peer-reviewed publications with his main interests in the epidemiology and prevention of healthcare-associated infections, especially Clostridium difficile infections, and the prevention of antimicrobial resistance.  Dr. McDonald’s Presentation Topic: “Clostridium difficile disinfecting and spores.”

Barley Chironda, Manager of Infection Prevention and Control (IPAC) and Medical Device Reprocessing Device at St. Joseph Health Centre in Toronto, Canada. He is certified in Infection prevention and control (CIC TM) and has worked extensively as an Infection Preventionist. Barely has been an integral to the successful decline in Clostridium difficile infections through implementing innovative technology and quality improvement behavioral changes.   Barley’s presentation will show a behind the scenes account of the C. diff. management from the healthcare facilities perspective while providing a call to action.

Dr. Patricia Pietrobon, Ph.D. , Associate Vice President, Research & Development Sanofi Pasteur  has over 25 years of experience in the Vaccine & Diagnostic industries and more then 20 years in leadership roles focusing on research & development of new vaccines. Patricia began her career in diagnostic assay development with a focus on validation and quality alignment to regulatory requirements and GXPs. Patricia has been with Sanofi Pasteur for over 25 years and has contributed to the development and licensure of new bacterial & viral vaccines for pediatric & adult populations worldwide.
Sanofi Pasteur

Dr. Martha Clokie, PhD, Leicester UK, Professor in Microbiology.  Dr. Cloakie’s research focuses on phages that infect bacterial pathogens of medical relevance and  has published 41 papers in this area. Her major focus has been on Clostridium difficile where she has  isolated a large phage collection. In vitro and in vivo data has shown that the viruses have therapeutic potential. A patent has been filed  on these phages and  working with AmpliPhi to develop a product. Dr. Cloakie  has regular contact with the BBC and other media to talk about her work, and other phage projects, and has consulted with Science museum, London and Eden Project, UK to advise on bacteriophage displays.

Professor Nancy Sheridan,   a C. diff. Survivor and  Associate Professor at the Fashion Institute of Technology and a winner of the prestigious SUNY Chancellor’s Award for Excellence in Teaching. Professor Sheridan will share her personal experience being treated for a painful and extended journey with a C. diff. infection (CDI).  Professor Sheridan has been teaching since fall 2000 in the Fashion Merchandising Management Department within the School of Business and Technology. For the past seven years, she has also taught at the University of Pennsylvania, Wharton Business School to undergraduate and MBA students.

Dr Mel Thomson, PhD,  completed her Honors degree in microbiology and immunology at the University of Melbourne . She then immigrated to the UK where she worked on various projects as diverse as allergy and cancer before undertaking further studies. She completed a Masters of Research in functional genomics before reading for a PhD in microbial genetic regulation in Neisseria species, both at University of York, UK. After the award of her PhD, Dr Thomson became interested the host-pathogen interactions at the Leeds Institute of Molecular Medicine, UK.  Dr Thomson returned to Australia in 2011 to start her own research group studying host-pathogen interactions in the GI tract, at Deakin Medical School. A passionate science communicator, she has recently become a national ‘torch bearer’ for the concept of crowd funding academic research, which a track record of three successful ‘Pozible’ crowd funding campaigns, ‘Mighty Maggots’, ‘Hips 4 Hipsters’ and ‘No more Poo Taboo’

+ many more……….

NOTE:  *Presentations are not to be recorded audio or video or published without the presenters written and signed permission to do so by each attendee seeking publication of said presentations.

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We look forward to meeting you in Boston, Massachusetts on November 9th

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 A suggested local travel coordinator, for your convenience

LibertyTraveldownloadMichael Beckman — Team Leader,  Liberty Travel, 467 Washington Street, Boston, MA  02111
617-936-2435
Michael.Beckman@flightcenter.com

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 We would like to sincerely thank the following Corporate Sponsors for their continued support for the “RAISING C. diff. AWARENESS” conference being hosted in Boston, MA

syntheticbiologics

CdifficileRandDLogo

 

AmericanGreenTechnologyhrms

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SporeGen Logo 2

In The News – Synthetic Biologics’ SYN-004 Microbiome-Protecting Preclinical Data Highlighted in Late-Breaking Poster at DDW 2015

syntheticbiologics

Synthetic Biologics, Inc.  a clinical-stage company focused on developing therapeutics to protect the microbiome while targeting pathogen-specific diseases, presented preclinical results in a late-breaking poster at Digestive Disease Week® (DDW) 2015 in Washington, DC today. The research supports the development of SYN-004, the Company’s candidate therapy designed to degrade certain intravenous (IV) beta-lactam antibiotics within the gastrointestinal (GI) tract and maintain the natural balance of the gut microbiome for the prevention of C. difficile infection and antibiotic-associated diarrhea (AAD). Beta-lactam antibiotics are a mainstay in hospital infection management, and include commonly used penicillin and cephalosporin antibiotics, such as ceftriaxone.

The “SYN-004, a Clinical Stage Oral Beta-Lactamase Therapy, Protects the Intestinal Microflora from Antibiotic-Mediated Damage in Humanized Pigs” poster summarized preclinical efficacy data that support the ability of SYN-004 to degrade certain beta-lactam antibiotics in the GI tract, with the following conclusions:

  • In fistulated dogs, oral delivery of SYN-004 resulted in efficient degradation of ceftriaxone in the GI tract, and
  • In humanized pigs, SYN-004 protected the intestinal microflora from ceftriaxone and maintained the natural balance of the microbiome.

“The data suggest that SYN-004 has the potential to protect the human microbiome and to become the first prophylactic therapy designed to prevent antibiotic-mediated microbiome damage, including C. difficile infection, in patients receiving beta-lactam antibiotics,” stated Michael Kaleko, M.D., Ph.D., Senior Vice President, Research & Development of Synthetic Biologics.

“These findings support our ongoing Phase 2a clinical trial that is evaluating the ability of two different dose strengths of SYN-004 to degrade residual IV ceftriaxone in the GI tract of up to 20 healthy participants with functioning ileostomies, without affecting the concentrations of IV ceftriaxone in the bloodstream,” noted Jeffrey Riley, Chief Executive Officer of Synthetic Biologics.

“We are on schedule to report topline data from the Phase 2a clinical trial of SYN-004 this quarter, with a Phase 2b clinical trial anticipated to initiate during the second half of this year.”

The U.S. Centers for Disease Control and Prevention (CDC) has categorized C. difficile as an “urgent public health threat,” and has stated the need for research to better understand the role of normal gut bacteria. SYN-004 is intended to block the unintended harmful effects of certain IV antibiotics within the GI tract and maintain the natural balance of the gut microbiome, potentially preventing the 1.1 million C. difficile infections[i] and 30,000 C. difficile-related deaths[ii] in the United States each year. Approximately 118 million doses of IV beta-lactam antibiotics[iii] that could be inactivated in the GI tract by SYN-004, were administered to approximately 14 million hospitalized U.S. patients during 2012.

About Synthetic Biologics, Inc.

Synthetic Biologics, Inc. (NYSE MKT: SYN) is a clinical-stage company focused on developing therapeutics to protect the microbiome while targeting pathogen-specific diseases. The Company is developing an oral biologic to protect the gut microbiome from intravenous (IV) antibiotics for the prevention of C. difficile infection and an oral statin treatment to reduce the impact of methane producing organisms on irritable bowel syndrome with constipation (IBS-C). In addition, the Company is developing a monoclonal antibody combination for the treatment of Pertussis in collaboration with Intrexon Corporation (NYSE: XON), and a Phase 2 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 potential for SYN-004 to protect the human microbiome and to become the first prophylactic therapy designed to prevent antibiotic-mediated microbiome damage, anticipated timing of the topline data from the Phase 2a and the initiation of the Phase 2b clinical trial and the size of the market. 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 ability of SYN-004 to perform as expected, the results of the clinical trials and other factors described in Synthetic Biologics’ report on Form 10-K for the year ended December 31, 2014 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] This information is an estimate derived from the use of information under license from the following IMS Health Incorporated information service: CDM Hospital database for full year 2012. IMS expressly reserves all rights, including rights of copying, distribution and republication.

[ii] U.S. Department of Health & Human Services. Agency for Healthcare Research and Quality. January 25, 2012. http://www.ahrq.gov/news/nn/nn012512.htm Accessed: September 30, 2013.

[iii] This information is an estimate derived from the use of information under license from the following IMS Health Incorporated information service: CDM Hospital database for full year 2012. IMS expressly reserves all rights, including rights of copying, distribution and republication.

 

 

*Please note – The C Diff Foundation does not endorse this product or any product and this posting is strictly for informational purposes only.

 

Synthetic Biologics Discuss Preventing C. diff. Infection with SYN-004 on “C diff Spores and More,” C. diff. Radio

cdiffRadioLogoMarch2015

 

Join us on Tuesday, March 31st at 11:00 a.m. Pacific, 1 p.m. Central, 2 p.m. Eastern Time for the live broadcast –  Synthetic Biologics: Preventing C. diff. Infection with SYN-004

 

 

 

Synthetic Biologic, Inc.’s  Lewis Barrett, BS, MBA, Senior Vice President, Commercial Strategy and Dr. Joseph A. Sliman, MD, MPH, Senior Vice President, Clinical & Regulatory Affairs will discuss the novel point-of-care preventive approach, the clinical development pathway and the potential of the Company’s lead pathogen-specific product candidate, SYN-004.

 

For direct access to the “C. diff. Spores and More Program” please click on the link below:

http://www.voiceamerica.com/episode/84381/synthetic-biologics-preventing-c-diff-infection-with-syn-004

 

The majority of C. difficile cases are caused by the unintended consequences of antibiotic therapy to the gut microbiome. Intravenous (IV) antibiotics excreted to the gut often wipe out the natural balance of microflora, which can lead to recurring diarrhea and perforation of the intestinal wall, with potentially fatal outcomes. Co-administered with IV
antibiotics, Synthetic Biologics’ product candidate, SYN-004, is designed to be a preventive therapy intended to protect the gut microbiome by degrading IV antibiotics, thereby preventing the onset  of  a C. difficile infection.
Synthetic Biologics, Inc. (NYSE MKT:SYN)

http://www.syntheticbiologics.com

 

 

*Please note – The C Diff Foundation does not endorse this product or any product and this posting is strictly for informational purposes only.