Tag Archives: Biological Research and Development Clostridium difficile

Trinity Guardion Bed Protection System Proven To Reduce C. diff., A Healthcare-Associated Infection, By 50%

IN THE NEWS………….

Trinity Guardion was selected by Xavier University’s Center for Innovation to present their Bed Protection System, which is proven to reduce a Hospital Acquired C.diff infection by 50%, at Healthovate! Summit on Thursday, June 11. The 2015

Xavier Center for Innovation (CFI) Healthovate! Summit is co-sponsored by Intel-GE Care Innovations. “Trinity Guardion is the world’s only manufacturer of launderable bed covers specifically engineered to eliminate bacteria, spores and viruses from a hospital bed mattress. I’m excited to present this patented technology with over 6 years of research behind it to this esteemed group of innovators,” states Bruce Rippe, Trinity Guardion’s Chief Operating Officer.

Healthovate! Summits give healthcare leaders an opportunity to share their expertise and engage in conversations with other leaders from other industries. Trinity Guardion will also be presenting at similar events in Boston (July 31), Chicago (Oct 5), and Nashville (Oct 28). “Our mission at the CFI is to use innovation to solve complex problems. I can’t think of a more important challenge facing our society than how we keep people healthy, while reducing costs and improving overall well-being,” said Shawn Nason, Chief Innovation Officer at Xavier University. “By bringing together a diverse community of people, all committed to health, I am confident we can find meaningful solutions and innovative technologies and systems that will transform the healthcare industry—not to mention better ways to educate and prepare students to work in and lead healthcare in the future.”

Over 40 area start-up hospitals, universities, national organizations, healthcare professionals, and Xavier alumni will learn how this innovative mattress cover acts as a barrier to prevent bacteria and fluids, which can be harbored in a hospital mattress as a result of ineffective cleaning, from coming in contact with a patient. Due to its abilities in preventing viruses such as Ebola and other bacteria from penetrating through the cover, hospitals have begun to implement the covers in their infection control wards. Last year, the innovative technology of the Trinity Bed Protection System was recognized when the honorable mention for the 2014 NALTH Goldberg Innovation Award was awarded to St. Vincent Seton Specialty Hospital, Indianapolis for their use of the mattress cover in their facility.

Tested in two Midwestern hospitals, the Trinity Bed Protection System does not impede bed operation or any clinical aspects of the underlying mattress. In fact, it helps reduce terminal clean time, while improving asset life of the bed.

The Trinity Bed Protection System from Trinity Guardion makes bed surfaces cleaner for every person every time.

About Trinity Guardion: Trinity Guardion is the result of an international collaboration of scientists, doctors and academic professionals in the healthcare industry, united in the concern that hospital beds are not clean. This concern was corroborated by peer reviewed research that is available upon request. The product line includes mattress covers for most brands of hospital beds, therapy tables and pillow cases.

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

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.

 

Clostridium difficile Biologic Research and Development; May 2014

 

 

 

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

Seeking Prevention/Treatment of Clostridium difficile Infection (CDI)

Biologic Research & Development
Seeking Prevention/Treatment of Clostridium difficile Infection (CDI)

As the name implies, biologics are medical agents (such as proteins, cells, or DNA) derived from biological sources used to prevent or treat disease. With advances in biotechnology, biotherapeutic agents are being investigated and/or developed to treat various medical conditions, including:
• Diabetes (human recombinant insulin)
• Anemia (human recombinant erythropoietin)
• Breast Cancer (trastuzumab, monoclonal antibody)
• Cutaneous T-Cell Lymphoma (denileukin difitox, bio-engineered protein)
• CDI (multiple biologics)
• Pertussis/whooping cough (monoclonal antibody)
• Rheumatoid Arthritis (multiple biologics)
• Psoriatic Arthritis (multiple biologics)
• Psoriasis (multiple biologics)

Extensive biologic R&D resources are directed toward preventing/treating CDI. These biologic agents can be described as either biopharmaceuticals, prebiotics or probiotics/live biotherapeutics.

Biopharmaceuticals
Created by biological process, rather than chemical synthesis, biopharmaceuticals, are medicinal products for the treatment, prevention, or cure of disease in humans. Biologics are generally derived from living material, i.e. microorganisms or cell culture. This is a significant contrast to chemically synthesized small molecule drugs that have a defined, and clearly characterized structure. Types of biopharmaceuticals include:
• Vaccines
• Monoclonal antibodies
• Therapeutic enzymes

Prebiotics
Prebiotics are a special type of naturally-occurring fiber that facilitates growth of beneficial (protective) bacteria already living in the colon; they promote an environment that is inhospitable to harmful bacteria. They are found in whole grains, garlic, onions, banana, artichokes and honey. Commercially available prebiotic fiber supplements are commonly used to insure sufficient fiber is ingested to promote a healthy colonic environment.
Probiotics / Live Biotherapeutics
The FDA describes probiotics as live microorganisms which, when administered in adequate amounts, confer a health benefit on the host. Probiotics are live microbes (bacteria or yeast) and can be regulated in the United States as both foods and drugs. Examples of probiotics classified as food are dietary supplements and yogurts.

The FDA classifies probiotics as “Live Biotherapeutics” when intended and/or marketed for disease prevention or treatment (probiotics for clinical use); they would require the FDA approval process that is required for drugs and biopharmaceuticals. Even though there have been some promising reports from probiotic biotherapeutic research, strong scientific evidence to support therapeutic use is not available. Currently, the FDA has not approved probiotics for any therapeutic claims.

Biopharmaceutical R&D Projects Seeking CDI Prevention/Treatment
• Vaccine to prevent CDI – Clostridium difficile toxoid vaccine
• Monoclonal antibody combination to prevent recurrent CDI
o Neutralize Clostridium difficile Toxin A and Toxin B
• Beta-lactamase enzyme to prevent CDI following parenteral beta-lactam therapy in hospitalized patients
• Live biotherapeutics to prevent CDI recurrence
o non-toxigenic Clostridium difficile spores in oral dose
o fecal microbiota transplantation
o defined compositions of fecal bacteria

 

April  2014

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