Tag Archives: C difficile bilogical research and development

#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

rebiotixlogoXenex_LogoLockups_PantoneC

BiovigilLogoII

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, Inc. and Enterome Bioscience SA enter into researching effects of beta-lactam antibiotics on the Microbiome

NewsSpeaker

 

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, and Enterome Bioscience SA, a pioneer in the development of innovative disease management solutions based on a deep understanding of the gut microbiome, today announced that they have entered into an agreement to conduct metagenomic research on the effects of beta-lactam antibiotics on the gastrointestinal microflora (microbiome) of human patients. As part of this collaboration, a clinical microbiome study of approximately 100 patients is expected to begin next month. Research findings should provide important insights as Synthetic Biologics advances the development of SYN-004, which is intended to protect the gut microbiome from the effects of intravenous (IV) beta-lactam antibiotics, and in particular to prevent C. difficile (C. diff) infections. Phase Ia and Ib clinical trials of Synthetic Biologics’ SYN-004 are scheduled to begin later this year.

The Enterome microbiome study, scheduled for completion in the second half of 2014, is expected to provide a better understanding of the harmful effects of beta-lactam antibiotics on the gut bacterial community. The goal is to establish a “fingerprint” of the damage caused by beta-lactam antibiotics, thus yielding a panel of bacterial biomarkers that can be leveraged for diagnostic purposes. This novel study should clearly define the impact of beta-lactam antibiotics on the natural bacterial diversity of the gut microbiome. Changes in the gut microbiome have been related to multiple diseases, including C. diff infections, antibiotic-associated diarrhea, obesity, diabetes and other metabolic diseases. This study will utilize Enterome’s state-of-the-art shotgun metagenomic sequencing technology to profile the human gut microbiome.

“We are pleased to establish this collaboration with Enterome, a pioneer in the development of biomarkers and therapies for diseases of the gut microbiome,” stated Jeffrey Riley, CEO of Synthetic Biologics. “Findings from this study should support our C. diff therapeutic program, which focuses on protecting and maintaining the balance of bacterial microflora in the gut, while also establishing our presence in Europe.”

Synthetic Biologics’ lead anti-infective product candidate, SYN-004, is the first therapy designed to neutralize IV antibiotics in the gut, and is intended to protect and maintain the balance of bacterial flora in the gastrointestinal tract, to prevent the devastating effects of C. diff. The U.S. Centers for Disease Control and Prevention (CDC) has classified C. diff as an “urgent public health threat”i, surpassing Methicillin-resistant Staphylococcus aureus (MRSA) as the number one hospital-acquired infection in the United States. C. diff is a multidrug-resistant bacterium that infects 1.1 million U.S. patients annuallyii. In the U.S., patients with C. diff are hospitalized an estimated 3.6-7 extra daysiii, costing more than $8.2 billioniv.

“The signing of this agreement with Synthetic Biologics is another important corporate milestone for Enterome. I am very pleased that our pioneering approach to understanding the linkage between changes in the gut microbiome and disease has convinced Synthetic Biologics to work with us on such an important personalized medicine project. It is clear that new diagnostic solutions are needed to properly address the growing problem of antibiotic-induced dysbiosis and associated hospital-acquired bacterial infections,” stated Pierre Belichard, CEO of Enterome. “Tailoring the use of anti-infective treatments based on microbiome profiling is beginning to show great promise as a way to address the management of infectious diseases.”

“Comparing Enterome’s technology to other genomic analyses of gut microbiome is like comparing a Quad Full High definition color resolution TV to resolution of an analog black & white TV,” added Mr. Riley.

About SYN-004 Clinical Development

Synthetic Biologics is developing SYN-004, a novel second generation oral enzyme drug candidate, to be co-administered with commonly used IV beta-lactam antibiotics and is intended to protect the gastrointestinal microflora (microbiome) from the harmful effects of such antibiotics, thus potentially preventing C. diff infections. Planned next steps for SYN-004 include: 1) initiation of a 28-day bridging toxicology study in June 2014; 2) filing of an Investigational New Drug (IND) application to initiate Phase Ia and Ib clinical trials in the second half of 2014, with preliminary topline data expected by year-end 2014; and, 3) initiation of a Phase II efficacy study is expected to begin in the first half of 2015.

About Enterome Bioscience SA

Enterome is pioneering the development of innovative disease management solutions based on a deep understanding of the gut microbiome. Understanding and modifying the changes that occur in the gut microbiome during disease and in response to therapeutic interventions represent an entirely new and untapped opportunity to impact medicine.

Initially Enterome is using its expertise and proprietary technologies to develop novel diagnostic products to support patient stratification, personalized therapies and the clinical development of new drugs for the treatment of microbiome-related diseases such as inflammatory bowel diseases and metabolic diseases (diabetes and obesity). Enterome’s unique Metagenotyping® process has allowed it to develop biomarkers for treatment response prediction, disease activity monitoring and as potential companion diagnostics.

The company was established in 2012 in Paris, France, and has raised a total of €17.5m from leading venture capital investors (Seventure, Omnes Capital & Lundbeckfond Ventures) and two strategic investors (Danone & Shire).  www.enterome.com

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.

 

* For article in its entirety please click on the following link:

http://www.prnewswire.com/news-releases/synthetic-biologics-and-enterome-bioscience-collaborate-on-microbiome-research-to-support-synthetic-biologics-c-difficile-program-262479001.html

Clostridium difficile Biologic Research and Development; May 2014

laboratorystill

 

 

 

Clostridium difficile Biologic Research & Development

Antibiotic administration is a risk factor for Clostridium difficile-associated disease (CDAD).

Excretion of antibiotics into the intestinal tract may lead to an alteration of the normal microflora, resulting in overgrowth of pathogenic bacteria including Clostridium difficile.       Stiefel, et al. have previously reported that oral administration of β-lactamase enzyme inactivates ampicillin and piperacillin in the small intestine. This study evaluates oral β-lactamase administration in combination with parenteral piperacillin or ampicillin in mice to validate the hypothesis that oral β-lactamase protects the microbiota and prevents          Clostridium difficile infection (CDI).
http://jac.oxfordjournals.org/content/62/5/1105.full.pdf+html

 

Brian Andresen, Chairperson of Biologic Research and Development Committee   (*)              *Michael Kaleko, MD, PhD, Senior Vice President, Reseaerch & Development Synthetic Biologics  *Joseph Sliman, MD, MPH, Senior Vice President, Clinical & Regulatory Affairs, Synthetic Biolgics *Andy Bristol, PhD, Vice President, Research & Development, Synthetic Biologics                   *Lewis Barrett, Senior Vice President, Commercial Strategy, Synthetic Biologics