Tag Archives: Clostridium difficile Biological R&D

C. difficile Infection (CDI) Prevention, Treatment, Environmental Safety, Research, Clinical Trials Being Discussed with World Topic Experts On September 20th In Atlanta, Georgia USA

September 20th

It is with great pride and certainty in the power of the healthcare community to present the 4th Annual International Raising. C. diff. Awareness Conference and Health Expo

being hosted at the

DoubleTree by Hilton — Atlanta Airport
3400 Norman Berry Drive
Atlanta,Georgia 30344 USA (Hotel Phone: 1-404-763-1600)

Doors open at 7:15 a.m — Sign In and Continental Breakfast

Conference begins at: 7:30 a.m. – 5:00 p.m.

T

Raising C. difficile awareness is essential to build upon and advance existing knowledge and necessary for overcoming the challenges our healthcare communities are faced with today.

“None of us can do this alone — All of us can do this together”

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). C. diff. is a leading cause of infectious disease death worldwide; 29,000 died within 30 days of the initial diagnosis in the USA. Previous studies indicate that C. diff. has become the most common microbial cause of healthcare-associated infections found in U.S. hospitals driving up costs to $4.8 billion each year in excess health care costs in acute care facilities alone.

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Clinical professionals gather for one day to present up-to-date data to expand on the existing knowledge and raise awareness of the urgency focused on a Clostridium difficile infection (CDI) —

Prevention
Treatments
Research
Environmental Safety
Clinical trials and studies

WITH

Microbiome research, studies
Infection Prevention
Fecal Microbiota Restoration and Transplants for Adults & Pediatrics
A Panel Of C. diff. Infection Survivors
Antibiotic Stewardship
Healthcare EXPO
……………………and much more.

You won’t want to miss out on this opportunity to learn from
International topic experts delivering data directed at evidence-based
prevention, treatments, and environmental safety in the C. diff.
and healthcare community.

Gain insights on September 20th that will not be available anywhere else with an opportunity to receive up-to-date data on major topics in this program being presented in one day.

5 Leading reasons to attend this dynamic conference:

Learn from leading healthcare professionals, clinicians, researchers, and industry.
Networking opportunities with new and reconnect with those in the healthcare community with similar interests.
Gain breakthrough results through research in progress and gaining positive results. Programs focused on Antibiotic-resistance such as the Antibiotic Stewardship making a difference. Front line developments in progress focused on C. diff. infection prevention, treatments, environmental safety.
Implement and share the knowledge well after the conference ends. Every attendee receives a booklet with guest speakers information, media to review audio programs, and Health Expo Sponsor information focused on the important agenda topics.
Embrace the opportunity, with all of the topic experts presenting, and hold the conference in the highest priority from the participation in this conference to an audience of medical students, and fellow healthcare professionals, who will benefit the most from the data and gain tools to overcome the barriers facing healthcare each day.

“The information and up-to-date studies shared at the 2015 conference added to an existing knowledge base that helps us to continue delivering quality care in the medical community.” Linda Davis, RN,BSN

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REGISTRATION FEES:

$75.00 — Conference Registration

$30.00 — Student Conference Registration (Student ID To Be Presented At the Door)

TO REGISTER Click on the “Raising C. diff. Awareness” Ribbon below

Room accommodations are available — Complete and Confirm

by August 19th to reserve your hotel reservations.

To create a reservation please click on the DoubleTree By Hilton Logo below – – – – – –

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A suggested travel coordinator, for your convenience

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

For Additional Information visit the C Diff Foundation Website:

https://cdifffoundation.org/

https://cdifffoundation.org/

And Click on the 2016 September Conference Tab

Follow us on Twitter
@cdiffFoundation
#Cdiff2016

Synthetic Biologics SYN-004 Intended for the Prevention of C. diff. Infection (CDI) and Antibiotic-Associated Diarrhea (AAD)

UPDATE:

Synthetic Biologics Announces Further U.S. Patent Successes Covering SYN-004 Intended for the Prevention of C. difficile Infection and Antibiotic-Associated Diarrhea

Synthetic Biologics, Inc. a clinical stage company focused on developing therapeutics to protect the gut microbiome, announced today that the U.S. Patent and Trademark Office (USPTO) issued Notices of Allowance for three patent applications which cover composition of matter claims and methods of protecting the gut microbiome from certain beta-lactam antibiotics for the prevention of C. difficile infection (CDI) and antibiotic-associated diarrhea (AAD). These new allowances further strengthen the Company’s novel proprietary candidate, SYN-004, which is also covered by a composition of matter patent in the U.S.

What is SYN-004?

SYN-004 is designed to degrade certain intravenous (IV) beta-lactam antibiotics excreted into the gastrointestinal (GI) tract to maintain the natural balance of the gut microbiome. C. difficile is associated with approximately 453,000 CDIs and > 29,000 C. difficile-related deaths in the United States each year[i].

Upon issuance, these newly allowed applications reinforce Synthetic Biologics’ extensive C. difficile-related patent estate, which includes approximately 35 U.S. and foreign patents and approximately 30 U.S. and foreign patent applications, and carry patent terms that extend from at least 2031 to 2035.

“These new patents will complement our growing SYN-004 patent estate and support our C. difficile prevention program, including two ongoing Phase 2 clinical trials,” said Jeffrey Riley, President and Chief Executive Officer of Synthetic Biologics. “We’re on schedule with respect to patient enrollment in our global Phase 2b proof-of-concept clinical trial intended to evaluate the ability of SYN-004 to prevent CDI and AAD in patients hospitalized with a lower-respiratory tract infection. During the first half of 2016, we also anticipate announcing topline data from the second Phase 2a clinical trial which is evaluating the ability of SYN-004 to degrade IV ceftriaxone in the presence of a proton pump inhibitor.”

About Synthetic Biologics, Inc. For more information, please visit Synthetic Biologics’ website at 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.

C. difficile Prevention Clinical Trials; Synthetic Biologics Announces Positive Results from Phase 1a of SYN-004

In the news:

**Synthetic Biologics Announces Positive Topline Results from Phase 1a Trial of SYN-004 for the Prevention of 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 positive top-line safety and tolerability results from a Phase 1a clinical trial of SYN-004, the Company’s investigational oral beta-lactamase enzyme for the prevention of Clostridium difficile (C. difficile) infection, antibiotic-associated diarrhea and secondary antibiotic-resistant infections in patients receiving intravenous (IV) beta-lactam antibiotic therapy.

Since December 2^nd, 2014 the randomized double-blind, placebo-controlled Phase 1a clinical trial conducted at Clinical Pharmacology of Miami, has enrolled 24 healthy volunteers in three cohorts of eight patients each. A total of 18 volunteers have been administered one dose of SYN-004 at increasing dose levels by cohort, and six volunteers received placebo. No clinically significant or relevant adverse events have been reported to date.

“Completing the first safety review and reporting positive top-line results in the Phase 1a clinical trial of SYN-004 is an important event for Synthetic Biologics, bringing us closer to the first potential point-of-care preventative therapy for C. difficile, the CDC’s top-ranking public health threat. Achieving this milestone moves us closer to validating our ground-breaking approach to preventing C. difficile infection in a way that protects the gut microbiome, which also holds the hope of treating a variety of GI, metabolic and CNS disorders,” said Jeffrey Riley, Chief Executive Officer of Synthetic Biologics.

Mr. Riley added, “Based on the results observed in the first three cohorts, and per our clinical plan, we intend to proceed with our planned multiple-ascending dose placebo-controlled Phase 1b study of SYN-004, in which healthy volunteers will receive increasing doses of SYN-004 over several days. We expect enrollment into our Phase 1b SYN-004 clinical trial to begin before year-end, with top-line data available during the first quarter of 2015. We also expect to initiate enrollment in a Phase 2 SYN-004 clinical trial ahead of schedule during the first quarter of 2015.”

SYN-004 is Synthetic Biologics’ oral drug candidate designed to be the first and only treatment intended to prevent C. difficile infection. Its mechanism of action is to bind with and neutralize certain common IV beta-lactam antibiotics in the gut.

During 2012, 14.4 million U.S. patients received approximately 117.6 million doses of IV antibiotics [i] that could be inactivated in the gastrointestinal (GI) tract by SYN-004.

SYN-004 is intended to block the unintended harmful effects of antibiotics within the GI tract, maintaining the natural balance of the bacterial flora (gut microbiome), potentially preventing the 1.1 million C. difficile infections[ii] and 30,000 C.difficile related deaths[iii] in the United States each year.

The U.S. Centers for Disease Control (CDC) has identified C. difficile as an “urgent public health threat” and occurs mostly in people who have had recent medical care with IV antibiotics. These antibiotics can create a harmful imbalance in the gut microbiome by killing “good” bacteria, giving C. difficile a chance to multiply and cause diarrhea, which can lead to dehydration, fever, abdominal pain, cramping, nausea, colitis, and even death. In all, 24 million Americans receive IV antibiotics annually [iv].

References:

[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] 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.

[iii] 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.

[iv] 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.

SOURCE Synthetic Biologics, Inc.

For further information: Synthetic Biologics:

Kris Maly, VP, Corporate Communication, (734) 332-7800, info@syntheticbiologics.com

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

https://ca.finance.yahoo.com/news/synthetic-biologics-announces-positive-topline-115800549.html

*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

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