Tag Archives: C Diff Clinical Trials

C. diff. In the News – New Antibiotic Could Treat C. diff. In Time

Access article/video in its entirety by clicking on the following link:

http://www.bbc.com/news/uk-scotland-34106754

New antibiotic could transform C. diff treatment

Clinical trials have begun of a treatment that could fight outbreaks of the bacterial infection Clostridium difficile.

Scientists at Strathclyde University (Scotland), who developed the antibiotic, say it is the first of a new class of drug that could transform the treatment of potentially fatal diseases.

 

 

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

C. diff. Infection Prevention Study: Phase 2 Study SER-109 by Seres Therapeutics; First Patient Dosed for the Prevention of Recurrent C. diff. Infection in Adults

* In The News *

Seres Therapeutics, Inc., a leading microbiome therapeutics platform company, announced on May 28th, 2015 the enrollment and dosing of the first patient in its Phase 2 clinical study of SER-109, an investigational oral microbiome therapeutic for the prevention of recurrent Clostridium difficile infection (CDI) in adults.

The objective of the Phase 2 study is to further assess the efficacy and safety of SER-109, Seres’ leading development candidate.

“Recurrent CDI is a rapidly growing problem in the U.S., and antibiotics are currently the only FDA-approved treatment option,” said Roger Pomerantz, Chairman, President and CEO of Seres. “For many patients, antibiotics may exacerbate the problem by inducing or prolonging an imbalance of the microbiome and creating the conditions that support disease recurrence. We are excited about evaluating the potential of SER-109 to correct the microbiome and address this critical patient need.

“The start of our Phase 2 study is an important milestone for patients, and for Seres.

Our earlier studies suggest that SER-109 is a potentially transformative therapeutic for tens of thousands of patients each year, validating our conviction that treating dysbiosis of the microbiome enables us to address the underlying cause of disease and bring about rapid improvements in health.”

Results from the Phase 1b/2 study of SER-109 in recurrent CDI patients showed that 87 percent of patients met the primary study endpoint and 97 percent of patients achieved a clinical cure, which was defined as the absence of CDI requiring antibiotic treatment during the eight-week period after SER-109 dosing.

The Phase 2 study is a multicenter, randomized, placebo-controlled study that will evaluate the efficacy and safety of SER-109. The primary outcome measure is the absence of clinically-significant CDI through eight weeks following administration of SER-109 compared to placebo. SER-109 will be administered orally as a single dose, following the standard of care antibiotics for CDI. The study is actively enrolling and will be conducted at approximately 35 centers across the U.S. The read-out from the Phase 2 study is currently expected in the middle of 2016.

About SER-109

SER-109 is the lead Seres Ecobiotic® microbiome therapeutic in clinical testing for the treatment of recurrent Clostridium difficile infection (CDI). SER-109 was developed utilizing the Seres Microbiome Therapeutics™ platform that provides deep insight into the ecologies of disease and then identifies microbial compositions that can catalyze a shift to health. CDI is a rapidly growing problem associated with antibiotic use. Approximately 85,000 to 110,000 CDI patients in the U.S. are expected to have more than one recurrence.

About Seres Therapeutics, Inc.

Seres Therapeutics, Inc. is a leading microbiome therapeutics platform company developing a novel class of biological drugs that are designed to treat disease by restoring the function of a dysbiotic microbiome.

 

For article in its entirety:

http://finance.yahoo.com/news/seres-therapeutics-inc-announces-first-113000601.html

 

 

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

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

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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.

 

Loyola Int’l C. diff. Research, Dr. Dale Gerding, MD Makes Important Breakthrough Towards the Prevention of Recurring C.diff. Infection

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In what is a major step towards the prevention of recurring bouts of Clostridium difficile (C.diff.) infection, an international team led by Dr. Dale Gerding, MD, Hines Veterans Administration (VA) research physician and professor of Medicine at Loyola University Chicago Stritch School of Medicine, has shown that giving spores of non-toxic C.diff. by mouth is effective in stopping repeated bouts of C.diff. infection which occurs in 25-30 percent of patients who suffer an initial episode of diarrhea or colitis.

 

The study is published in the May 5 issue of the Journal of American Medical Association (JAMA) and is the focus of a JAMA-produced video.

“The results of this study are very gratifying because the preclinical laboratory and patient studies were all done through our VA research program supported by the Department of Veterans Affairs Research Service,” says Gerding. “Results of this study confirm findings of earlier studies that showed that if we can establish non-toxic C.diff. as a resident of the gut of the patient, that we can protect the patient from infection by the toxic strains of C.diff..” Viropharma and Shire pharmaceutical companies supported the clinical trials.

These results warrant additional study to confirm that treatment with non-toxic C.diff. spores can reduce recurrent C.diff. infection and prevent a first episode of C.diff. infection in those who are taking any antibiotics and are at high risk of infection, he added.

Gerding and an international team of infectious disease researchers, including those at Loyola University Medical Center (LUMC), randomly assigned 168 adult patients with C.diff. infection who had been treated for their infection with antibiotics to receive doses of 10 thousand or 10 million spores per day of non-toxic C.diff. in liquid form for 7 or 14 days, or to receive an identical placebo. Of those assigned any dose of non-toxic C.diff. , 11 percent experienced a repeat of infection within 42 days compared with 30 percent of those given a placebo, a statistically significant reduction. For the most favorable dose tested, 10 million spores a day for 7 days, the recurrence of C.diff. infection was reduced to 5 percent.

Healthcare-acquired infections (HAI) including a leading HAI, C.diff. causes severe diarrhea and inflammation of the lower bowel or colon, continues to escalate in frequency and severity in the U.S.

According to the Centers for Disease Control and Prevention (CDC) report published in
February 2015, almost 500,000 C.diff. infections occurred in the U.S. in 2011, with 83,000 recurrences and 29,000 deaths within 30 days of diagnosis.  Older adults taking antibiotics and who receive care at medical institutions have a higher risk at acquiring this infection.

Cheryl O’Riordan, who has had repeated bouts of C.diff. infection, said having C.diff. made her visit the bathroom on an average of 10 times per day. “Before receiving effective treatment, I was unable to leave the house,” says the active cyclist, skier and hiker. O’Riordan went into remission after being treated successfully at LUMC. “I am back cycling more than 3 miles every day and have several major adventure trips planned.”

Gerding, who has published more than 135 studies on C.diff. is considered one of the leading international experts on C.diff..

Stuart Johnson, MD, infectious disease specialist at LUMC, is also the director of research at Hines VA hospital. Together Gerding and Johnson have partnered on C.diff. research for almost three decades, involving many LUMC patients.

“The study offers real hope for those debilitated by recurring bouts of C.diff.,” says Johnson “This study represents a novel and potentially highly effective bacteriotherapy approach to restoring colonization resistance against toxic strains of C.diff. in these patients,” he adds.

Loyola University Health System is recognized internationally as a leader in infection control and prevention.

LUMC is one of a few select hospitals who invest in universal screening of all inpatients for MRSA. Loyola was one of the first institutions to require all staff to have mandatory flu shots as a condition of employment. Loyola was one of several academic hospitals that participated in this recent benchmark international study.

 

To review article in its entirety click on the following link:

http://www.eurekalert.org/pub_releases/2015-05/luhs-lso050115.php

Study Advances Development of Preventative Approach for C. difficile Infection – Synthetic Biologics Initiates Phase 2a Clinical Trial of SYN-004 to Protect the Microbiome and Prevent C. difficile

Study Advances Development of Preventive Approach for C. difficile Infection
Synthetic Biologics, Inc..   a developer of pathogen-specific therapies for serious infections and diseases, with a focus on protecting the microbiome,  announced on March 30, 2015, the initiation of a Phase 2a clinical trial to evaluate the gastrointestinal (GI) antibiotic-degrading effects and the safety of SYN-004, the Company’s investigational oral beta-lactamase enzyme designed to protect the microbiome and prevent C. difficile infection (CDI). C. difficile is the leading type of hospital acquired infection and is frequently associated with intravenous (IV) antibiotic treatment. Beta-lactam antibiotics are a mainstay in hospital infection management, and include commonly used penicillin and cephalosporin antibiotics, such as ceftriaxone.
“We are excited to start our Phase 2a trial of SYN-004 on schedule. Synthetic Biologics believes SYN-004 holds the potential to protect the microbiome from the damaging effects of antibiotics and dramatically reduce C. difficile infections through prevention vs. treatment,” said Jeffrey Riley, Chief Executive Officer of Synthetic Biologics. “We anticipate reporting topline results from this Phase 2a clinical trial during the second quarter of 2015, and initiating the Phase 2b clinical trial in 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 antibiotics within the GI tract and maintain the natural balance of the gut microbiome, potentially preventing the 1.1 million C. difficile infections and 30,000 C. difficile-related deaths  in the United States each year. During 2012, approximately 14 million U.S. patients received approximately 118 million doses of IV beta-lactam antibiotics that could be inactivated in the GI tract by SYN-004.

https://cdifffoundation.org/2015/02/25/c-diff-new-cdc-study-national-burden-of-clostridium-difficile-c-diff-infections/
The Phase 2a randomized, multi-center, open-label study is expected to evaluate 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. The study consists of two treatment phases for all participants: 1) the administration of IV ceftriaxone alone, and 2) the administration of one of two doses of oral SYN-004 and IV ceftriaxone. Chyme samples will be collected from the participants to measure the ability of SYN-004 to degrade the residual antibiotic. Participants will be enrolled at up to four trial sites located in the United States and Canada.

For more information visit Synthetic Biologics website:

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.

Sanofi Pasteur Discusses Developing a Preventative C.diff. Infection Vaccine March 17, 2015 with C Diff Foundation’s ‘C diff Spores and More’ #CdiffRadio

cdiffRadioLogoMarch2015C. diff. Spores and More”

We invite you to join us in listening to this exciting episode on March 17th, 2015 and every Tuesday at the following times:

11a – 12p PT, 12p – 1pm MT, 1 pm – 2 pm CT,                              2 pm – 3 pm ET

 

Sanofi Pasteur, one of the leading vaccine manufacturers in the world, is currently conducting a Phase III clinical trial called Cdiffense in more than 20 countries across 5 continents to evaluate the safety, immunogenicity and efficacy of an investigational vaccine for the prevention of primary, symptomatic Clostridium difficile infection (CDI). The Cdiffense Phase III clinical program hopes to recruit up to 15,000 adults over 200 sites across the 20+ countries.

SANOFI Pasteur - RVB - Colors[1]Sanofi Pasteur’s Dr. Christian Felter, MD is Associate VP, Global Medical Expert for Nosocomial Vaccines for Sanofi Pasteur based in Lyon, France. His focus is on their investigative Clostridium difficile vaccine.

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.

Dr. Guy de Bruyn, Director for Clinical Development at Sanofi Pasteur, overseeing a large phase III vaccine trial for the prevention of Clostridium difficile infection in some 19 countries on 5 continents around the world that started in the U.S. in 2013.

Listen in on March 17th  as these three  Sanofi Pasteur professionals discuss the background of acquiring a C.difficile infection,  Sanofi Pasteur’s Phase III clinical trial called Cdiffense,  and data from the preventative vaccine in Phase II

Click on the link below to access the C. diff. Spores and More Show Page:

www.voiceamerica.com/show/2441/c-diff-spores-and-more

 

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C. diff. and Healthcare-Associated Infections Discussed Live on C. diff. Radio

CdiffRadioPost

#CdiffRadio

C Diff Foundation, Sponsor, with Founder            Nancy C. Caralla, Executive Director and               Dr. Chandrabali Ghose, Chairperson of the Research and Development Community will be broadcasting live on Tuesdays delivering the most up-to-date information pertaining to a leading super-bug/ Healthcare Associated Infection (HAI),  C. difficile, with additional HAI’s, and a variety of related healthcare topics.

Topic experts will be joining your hosts to discuss prevention, treatments, clinical trials, and environmental safety products on a global level.

Tune in Tuesdays beginning March 3rd at 11 AM Pacific Time (2 PM Eastern Time, 7 PM UK) on the VoiceAmerica network  http://www.voiceamerica.com/show/2441/c-diff-spores-and-more