Tag Archives: c difficile

Seres Therapeutics SER-109 Phase 3 Clinical Study For Recurrent C. diff. Infection Initiated

Seres Therapeutics Initiates SER-109 Phase 3 Study in Patients with Multiply

Recurrent C. difficile Infection

 

Jun. 12, 2017– Seres Therapeutics, Inc.

announced the initiation of its Phase 3 SER-109 clinical study (ECOSPOR III) in patients with multiply recurrent C. difficile infection. Based on recent interactions with the U.S. Food and Drug Administration (FDA), ECOSPOR III will now be designated a Phase 3 trial and the company expects that this single pivotal study may support SER-109 registration and approval.

“We are extremely pleased to be able to initiate the SER-109 Phase 3 ECOSPOR III study. If ECOSPOR III is successful, we believe this study could serve as the basis for SER-109 approval. Our goal is to have SER-109 approved as the first microbiome drug in this new field of medicine, and the first for patients with multiply recurrent C. difficile infection, an area of very high unmet need for patients in the U.S. and around the world,” said Roger J. Pomerantz, M.D., President, CEO and Chairman of Seres.

The ECOSPOR III Phase 3 study design incorporates direct learnings from prior SER-109 development efforts, as well as helpful feedback obtained from the FDA and study investigators. The study is expected to enroll approximately 320 patients with multiply recurrent C. difficile infection, randomized 1:1 to either SER-109 or placebo. The study is sized to contribute to an adequate safety database that may support product licensure. ECOSPOR III will utilize more than 100 clinical sites across the U.S. and Canada. The study’s primary endpoint will compare the reduction of C. difficile recurrence rates in subjects who receive SER-109 verses placebo at up to eight weeks after dosing.

The initiation of the SER-109 Phase 3 ECOSPOR III study triggers a $20 million milestone payment under the company’s previously announced development and commercialization collaboration agreement with Nestlé Health Science. In partnership with Nestlé Health Science, Seres plans to accelerate interactions with European regulatory agencies in the coming months to establish a path toward SER-109 product approval across Europe.

About SER-109 and C. difficile Infection

SER-109, an oral capsule, is Seres’ lead Ecobiotic® microbiome therapeutic for the treatment of multiply recurrent C. difficile infection. SER-109 is a biologically sourced consortium of bacterial spores designed to catalyze a shift in a dysbiotic gastrointestinal microbiome to a healthier state. The FDA has granted SER-109 both Breakthrough Therapy and Orphan Drug Designations.

C. difficile infection is one of the top three most urgent antibiotic-resistant bacterial threats in the United States according to the Centers for Disease Control. C. difficile is a leading cause of hospital acquired infection in the U.S. and is responsible for the death of approximately 29,000 Americans each year.

To read the article in its entirety please visit Seres Therapeutics Website:

http://serestherapeutics.com/about

Contagion Live Infectious Diseases Today Report 2017 SHEA’s Spring Conference

for Read the Article In Its Entirety Please Click On the Following Link:

Healthcare-associated infections (HAIs) continue to plague hospitals and long-term care facilities across the country, although, a recent report from shows that strategies to prevent these infections have made progress in decreasing their incidence since 2010. Still, the Centers for Disease Control and Prevention (CDC) has stated that a least one healthcare-associated infection is reported in about one in 25 hospitals on any given day.

When it comes to keeping up on the latest news regarding these harmful infections, the newest strategies being used to prevent them, antimicrobial stewardship efforts, and treating infections caused by organisms that have managed to develop resistance to current antibiotics, the annual Society for Healthcare Epidemiology of America (SHEA) Spring Conference is a gold mine packed full of information from key opinion leaders in the field, and Contagion® will be reporting on the conference for the second year in a row.

Since our inception in February 2016, Contagion® has kept readers current on new findings pertaining to healthcare-associated infections. Two of the big culprits that are most commonly behind these harmful and costly infections are Clostridium difficile and Staphylococcus aureus.

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At last year’s SHEA Conference, we interviewed Robin Jump, MD, PhD, about the burden of C. difficile in the hospital setting and up-and-coming prevention methods that healthcare providers can use to help manage these infections.

– See more at: http://www.contagionlive.com/news/contagion-to-report-on-2017-shea-spring-conference#sthash.kxaDnByE.dpuf

Rebiotix Treats First Patient In Phase 1 Study of RBX7455 Oral Capsule – A Formulation of Rebiotix’s Microbiota Restoration Therapy (MRT)

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Rebiotix Treats First Patient in Phase 1 Study of RBX7455, an Orally Delivered Broad-Spectrum Non-Frozen MicrobiotaROSEVILLE, Minn., Jan. 4, 2017

 

Rebiotix Inc., a clinical-stage biotechnology company focused on harnessing the power of the human microbiome to treat challenging diseases, announced today that the first patient has been treated in a Phase 1 study of RBX7455 for the prevention of recurrent Clostridium difficile (C. diff.) infection.

RBX7455 is a lyophilized non-frozen oral capsule formulation of Rebiotix’s Microbiota Restoration Therapy (MRT), a standardized, stabilized drug technology that is designed to rehabilitate the human microbiome by delivering a broad spectrum of live microbes into a patient’s intestinal tract via a ready-to-use and easy-to-administer format.

RBX7455 lyophilized capsules remove the need for patients to keep the product frozen or refrigerated.

This prospective, single center, two-arm Phase 1 study is a proof of concept dosing study of RBX7455 for the prevention of recurrent C. diff. infection, an increasingly difficult-to-resolve intestinal infection that causes approximately 29,000 deaths in the U.S. each year.1 It is also the first clinical study of an oral microbiota therapy that allows the patient to take the medication at home.

  • RBX7455 requires no special handling or storage needs for patients. The study will enroll approximately 20 patients at a single U.S. site and is being conducted by the Mayo Clinic, a nonprofit worldwide leader in medical care, research and education.

“New therapies are urgently needed to prevent recurrent C. diff., a debilitating, costly and potentially life-threatening infection,” said Dr. Sahil Khanna, Assistant Professor of Medicine, Department of Gastroenterology and Hepatology, Mayo Clinic, who is leading the study. “RBX7455 not only provides standardized and stabilized human microbes orally, but may provide several advantages in terms of patient dosing and therapy accessibility since no freezing or refrigeration is needed when the patient takes the product home.”

The initiation of the Phase 1 study of RBX7455 enhances Rebiotix’s clinical pipeline of human microbiome-directed drug candidates. The Company’s lead drug candidate, RBX2660, recently completed a Phase 2b randomized, double-blind placebo-controlled trial examining the efficacy and safety of the microbiota restoration therapeutic as a prevention for recurrent C. diff. infection after a standard of care course of antibiotics (PUNCH™ CD2).

“Dosing the first patient in the Phase 1 study of RBX7455 is a significant milestone for Rebiotix as it solidifies our position as the most clinically advanced microbiome company in the industry, while showcasing the potential of our MRT platform to create new solutions for challenging diseases through standardized microbiota-based drug development,” stated Lee Jones, president and CEO of Rebiotix. ”

RBX7455 is a potentially ground-breaking product for Rebiotix and the entire microbiome industry in that the lyophilized oral capsules do not need to be kept frozen and thus can be stocked in a pharmacy with no special handling or storage needs. As such, RBX7455 offers the unique opportunity to introduce live microbial therapy as a potential treatment for numerous diseases where chronic or repeat dosing is required.”

To read the article in its entirety please click on the following link to be redirected
*Please note – The C Diff Foundation does not endorse any products and/or clinical study in progress. All website postings are strictly for informational purposes only. Thank You.

FDA Grants Qualified Infectious Disease Product and Fast Track Designation To Morphochem’s IV Antibacterial Product Candidate MCB3837 To Treat C.diff. Infections

Morphochem is a clinical-stage pharmaceutical company, announced July 25, 2016 that the U.S. Food and Drug Administration (FDA) has designated Morphochem’s intravenous (IV) antibacterial product candidate MCB3837 as a Qualified Infectious Disease Product (QIDP) for the treatment of Clostridium difficile infection (CDI).

At the same time, the FDA has granted Fast Track designation to the compound’s development program for the treatment of CDI. MCB3837 is the IV prodrug of MCB3681, an antibacterial targeted at the treatment of CDI, which is a serious and potentially fatal disease regarded as an urgent healthcare threat.

Under the Generating Antibiotic Incentives Now (GAIN) title of the FDA Safety and Innovation Act, the QIDP designation provides certain incentives for the development of new antibacterial drug products, such as priority review and additional five years of marketing exclusivity granted at the time of marketing approval. The Fast Track designation enables more frequent interactions with the FDA, often leading to earlier drug approval and access for patients.

“After the U.S. FDA’s acceptance of Morphochem’s IND in June, we are glad to have now received both QIDP and Fast Track designation for MCB3837” says Thomas Kapsner, M.D., Morphochem’s Chief Executive Officer. “These designations will help us to expedite the development of this promising IV compound for the many severely ill CDI patients who cannot be treated orally. By providing an effective IV therapy, we aim to improve the prospects and quality of life of these patients.”

Morphochem is planning to initiate a proof-of-concept Phase 2 clinical trial of MCB3837/3681 in severe CDI patients in H2 2016.

About MCB3837/MCB3681 MCB3837 is a water-soluble injectable small-molecule prodrug of the active substance MCB3681, which is being developed for the IV treatment of CDI. Three Phase 1 clinical studies have proved MCB3837/MCB3681 to be safe and tolerable. In pre-clinical studies, MCB3681 demonstrated remarkable Gram-positive antimicrobial activity against C. difficile pathogens including the highly virulent BI/NAP1/027 strain, with no cross-resistance to any established class of antibacterial.

In a multiple-dose Phase 1b study with healthy volunteers, high fecal concentrations of MCB3681 were observed resulting in a pronounced effect on clostridia and other Gram-positive species while sparing Gram-negative species, including the bacteroides that protect the intestine against colonization with harmful pathogens potentially causing gastrointestinal infections. Due to this strong pharmacodynamic effect in humans, its narrow Gram-positive spectrum, and its favorable impact on the commensal flora, MCB3681 has the potential to target C. difficile pathogens selectively and effectively.

 

Key risk factors for developing CDI include the use of antibiotics (as they suppress the normal bowel flora) and advanced age. Up to 40 percent of patients develop severe / severe and complicated CDI, associated with significantly higher morbidity and mortality rates. Treatment is currently dominated by oral therapies which, however, tend to prove ineffective for severely ill patients as they often have difficulties swallowing or digesting tablets, or problems retaining the oral medication in or moving it along the gastrointestinal tract. Alternatives are limited, as there is no approved IV therapy available at present.

About Morphochem Morphochem Aktiengesellschaft für kombinatorische Chemie is a private clinical-stage pharmaceutical company located in Munich, Germany. Morphochem is a 100-percent subsidiary of Biovertis AG, headquartered in Vienna, Austria.  Biovertis’s major shareholder is TVM Capital Life Science.  Morphochem is fully dedicated to the development and commercialization of MCB3837/MCB3681, which the company hopes to introduce as the first approved intravenous therapy for severe Clostridium difficile infections.

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

http://www.einnews.com/pr_news/336679603/fda-grants-qidp-and-fast-track-designations-to-mcb3837-morphochem-s-novel-intravenous-antibacterial-to-treat-c-difficile-infections

 

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

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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.

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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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Cdiff2015-1Clinical 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

 ……………………………………………………………………………………………………………..

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

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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

LibertyTraveldownloadMichael 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

NEW Clorox Healthcare Fuzion Cleaner Disinfectant Kills 36 Microorganisms, Including C. difficile Spores, In 2 Minutes Or Less

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CLOROX HEATLHCARE

Kills 36 Microorganisms in 2 Minutes or Less

Now You Can Use Bleach in More Places than Ever Before     HEALTHCARE

A next-generation bleach product that kills C. difficile spores in 2 minutes, has broad surface compatibility for everyday use, and has a low odor that disappears within minutes.

Use Sites and Applications

Medical: Autoclaves, bedrails, bedside tables, carts, counters, computer screens, diagnostic equipment, dialysis machines, glucometers, gurneys, IV pumps, patient monitoring equipment, plastic mattress covers, remote controls, shower fixtures, stretchers, toilet handholds, walls around toilet/patient rooms, wash basins, wheelchairs, x-ray equipment

  • Dental: Countertops, dentist chairs, endodontic equipment, instrument trays, light lens covers, operatory surfaces, reception counters/desks
  • Veterinary: Animal equipment, transportation vehicles, veterinary care surfaces
  • General Use/Miscellaneous surfaces: Bed frames, doorknobs, hand railings, changing tables, highchairs, playpens, bath tubs, sinks and toilets

 

Directions for Use

  1. REMOVE gross soil if visible. For C. difficile spores and TB, always clean surface prior to disinfecting.
  2. SPRAY 6″–8″ from surface until surface is completely wet.
  3. To DISINFECT, let stand for 1 minute. To kill C. difficile spores, allow 2 minutes contact.
  4. WIPE with a clean, damp cloth. Allow to air dry.

CAUTION: Moderate eye irritant. Do not get in eyes or on clothing. Wash thoroughly with soap and water after handling and before eating, drinking, chewing gum, using tobacco, or going to the toilet.

Click on the link below to be redirected to the Clorox Healthcare website:

https://www.cloroxprofessional.com/products/clorox-healthcare-fuzion-cleaner-disinfectant/at-a-glance/

  • Please Contact CLOROX HEALTHCARE with any questions or concerns regarding Clorox products.

 

NOTE:  The C Diff Foundation Does Not Endorse or Promote Any Products Or Services Shared On This Website, This Posting Is Strictly For Information Purposes Only.

C. diff. Spores and More Discuss Rebiotix: The Leader In Unlocking the Benefits of Microbiota Restoration Therapy (MRT) With Founder and CEO, Lee Jones

Listen To The May 31, 2016 PodCast

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To access the live broadcast and Podcast Library
C. diff. Spores and More  Global Broadcasting Network
please click on the logo above *

C. diff. Spores and More,” Global Broadcasting Network – innovative and educational interactive healthcare talk radio program discusses

This Episode:       Rebiotix: The Leader in Unlocking the Benefits of Microbiota  Restoration Therapy (MRT)  “

With Our Guest:              Lee Jones, Founder and CEO, Rebiotix

Join us today on C. diff. Spores and More discuss Rebiotix
with Rebiotix Founder, CEO Lee Jones.  Listen in as we learn more about
the History, Company profile, the problems they are solving, and product information.  Lee will explain What is the microbiome? Their first product RBX 2660 – addressing C. diff, with the Rebiotix platform called MRT (Microbiota Restoration Therapy) and how  MRT is different
and much more.  

MORE ABOUT OUR GUEST:

Lee Jones, CEO and Founder of Rebiotix Inc., is an experienced medical technology executive and serial entrepreneur. With deep experience in the medical devices industry and in managing and advising academic scientists on commercialization efforts, Rebiotix marks her first foray into biotechnology. She is leading a fast-paced effort to develop a new way of treating disease through Microbiota Restoration Therapy (MRT). The company’s first MRT is a biologic drug targeted at recurrent Clostridium difficile infection.
Rebiotix Founder, President, CEO,  Privately held biotechnology company founded in 2011   Developing a new category of drugs to harness the human microbiome to treat disease; involves transplantation of live human-derived microbes; first target is recurrent Clostridium difficile infection, Led pioneering work with the US Food and Drug Administration to develop a new classification for the product – RBX2660 – completed Phase 2 clinical testing.

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C. diff. Spores and More ™“ Global Broadcasting Network spotlights world renowned topic experts, research scientists, healthcare professionals, organization representatives,C. diff. survivors, board members, and C Diff Foundation volunteers who are all creating positive changes in the C. diff. community worldwide.

Through their interviews, the C Diff Foundation mission will connect, educate, and empower many worldwide.

Questions received through the show page portal will be reviewed and addressed  by the show’s Medical Correspondent, Dr. Fred Zar, MD, FACP,  Dr. Fred Zar is a Professor of Clinical Medicine, Vice HeZarPhotoWebsiteTop (2)ad for Education in the Department of Medicine, and Program Director of the Internal Medicine Residency at the University of Illinois at Chicago.  Over the last two decades he has been a pioneer in the study of the treatment of
Clostridium difficile disease and the need to stratify patients by disease severity.

To access the C. diff. Spores and More program page and library, please click on the following link:    www.voiceamerica.com/show/2441/c-diff-spores-and-more

Take our show on the go…………..download a mobile app today

http://www.voiceamerica.com/company/mobileapps

Programming for C. diff. Spores and More ™  is made possible through our official  Sponsor;  Clorox Healthcare

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