Monthly Archives: December 2014

C. diff. - Valneva Announced the Start of Phase II Clinical Trial of its C. diff. Vaccine Candidate

NewsSpeakerValneva Announces Start of Phase II Clinical Trial of its Clostridium difficile vaccine candidate

  • First Study participant(s) enrolled in Phase II trial which aims to enable Phase III entry upon successful completion
  • Study to enroll 500 healthy subjects aged 50 years and older in the United States and Germany
  • First results are expected in Q4 2015

* News Provided in English, French, and German *

Lyon (France), December 18, 2014 - European biotechnology company Valneva SE (“Valneva”) announced today the initiation of the Phase II clinical trial of its VLA84 prophylactic vaccine candidate against Clostridium difficile (C. difficile), the main cause of nosocomial diarrhea. Data from the Phase I study in healthy elderly and adults showed good safety and immunogenicity of the vaccine candidate, and indicated functionality of induced antibodies, supporting the Company`s decision to progress the vaccine candidate into Phase II

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Valneva annonce l`initiation de l`essai clinique de Phase II pour son candidat vaccin contre le Clostridium difficile

  • Premier volontaire recruté pour l`essai de Phase II qui, une fois achevé, devrait conduire à l`initiation de la Phase III
  • L`étude de Phase II vise à recruter 500 volontaires âgés de 50 ans et plus aux Etats-Unis et en Allemagne
  • Premiers résultats attendus au T4 2015

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Lyon (France), 18 décembre 2014 -La société de biotechnologie européenne Valneva SE (“Valneva”) annonce aujourd`hui le lancement de l`essai clinique de Phase II de son candidat vaccin prophylactique VLA84 contre le Clostridium difficile (C. difficile), principale cause de diarrhée nosocomiale. Les données de Phase I chez des adultes et des personnes âgées en bonne santé ont démontré un bon profil d`innocuité et d`immunogénicité du candidat vaccin ainsi qu`un bon fonctionnement des anticorps produits, conduisant ainsi la société à faire progresser son candidat vaccin en Phase II.

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Valneva gibt den Start einer klinischen Phase-II Studie mit seinem Impfstoffkandidaten gegen Clostridium difficile bekannt

  • Erste(r) Studienteilnehmer wurde(n) in die Phase II-Studie aufgenommen, die nach erfolgreichem Abschluss eine Phase III-Studie ermöglichen soll
  • Studie wird 500 gesunde Probanden im Alter von 50 Jahren oder älter in den USA und Deutschland umfassen
  • Erste Ergebnisse werden im 4. Quartal 2015 erwartet

Lyon (Frankreich), 18. Dezember 2014 - Das europäische Biotech Unternehmen Valneva SE (“Valneva”) hat heute den Start der klinischen Phase II-Studie ihres prophylaktischen Impfstoffkandidaten VLA84 gegen Clostridum difficile (C. difficile), die Hauptursache von nosokomialen Durchfallerkrankungen, bekannt gegeben. Die Daten aus der vorangegangenen Phase I-Studie in gesunden jüngeren Erwachsenen und älteren Personen zeigten bereits erste gute Sicherheits- und Immunogenitätsdaten des Impfstoffkandidaten, und deuteten auf die Funktionalität der induzierten Antikörper hin, weshalb sich das Unternehmen für die Weiterentwicklung des Impfstoffkandidaten in einer Phase II entschieden hat.

C. diff. Research and Development Community; November/December 2014

laboratorybeakers3

Here’s the latest from the

C. diff. Research Community:

 

 
Animal models of Clostridium difficile infection (CDI) are essential for the better understanding of this disease. The historical animal model for studying CDI was the Golden Syrian hamster, and the murine model for CDI has been described by Dr. Ciaran Kelly’s group in 2008. In this current study, Koenigsknecht et al. have used the antibiotic-treated murine model to describe in great detail the early dynamics of CDI in mice from ingestion and colonization, germination and colitis.
http://iai.asm.org/content/early/2014/12/16/IAI.02768-14.long

 

The role of host microbiota in the development of C. diff. infection (CDI) has been studied in great detail. In the current issue of Cell Host Microbe, two studies have looked at two different pathogens and their interactions with host microbiota.

In the first study, by Ferreyra et al, the authors show that following antibiotic treatment C. difficile uses host microbiota produced succinate to colonize the gut and cause diarrhea.

In the second study, Curtis et al. show that Bacteroides thetaiotaomicron enhances the expression of virulence genes of enterohemorrhagic Escherichia coli (EHEC) leading to EHEC colonization. B.thetaiotaomicron leads to increased levels of succinate which in turn is sensed by transcription factor Cra, which then leads to the enhanced expression of virulence genes in EHEC.

Although commensal microbiota often prevents pathogens from gaining a foothold in the gut by providing colonization resistance, gut pathogen have evolved in ways so that they can exploit metabolites produced by commnesals to use for their own advantage.

http://ac.els-cdn.com/S1931312814004193/1-s2.0-S1931312814004193-main.pdf?_tid=6ff3eb40-8f91-11e4-b02e-00000aab0f6b&acdnat=1419881733_d475a24b936814a7c30ed35c6ffeffb7
http://ac.els-cdn.com/S1931312814004211/1-s2.0-S1931312814004211-main.pdf?_tid=b1cc6540-8f93-11e4-a2e9-00000aab0f6b&acdnat=1419882703_c8e4440013034567236b8bf782708315

 

Several journal articles in December have been published looking at the efficacy of LFF571 in treateing CDI. LFF571 is a novel semi-synthetic thiopeptide antibacterial that inhibits bacterial protein synthesis.

The first article includes results from a Phase 2 exploratory study where the authors compared the safety and efficacy (based on a non-inferiority analysis) of LFF571 to vancomycin in adults with primary episodes or first recurrences of moderate C. difficile. Results show that based on protocol-specified definition, rates of clinical cure for LFF571 were non-inferior to those of vancomycin, recurrences were lower for LFF571 and LFF571 was generally safe and well-tolerated.
The second article compares the pharmacokinetics (PK) of LFF571 and vancomycin in patients with a C. difficile infection (CDI) as part of an early efficacy study. Patients were randomized to receive 200 mg of LFF571 or 125 mg of vancomycin four times daily for 10 days. The highest LFF571 serum concentration was 41.7 ng/mL. This is in comparison to peak vancomycin serum level at 2.73 μg/mL. CDI patients had high fecal concentrations and low serum levels of LFF571 which is similar to healthy volunteers.
http://aac.asm.org/content/early/2014/12/16/AAC.04251-14.long
http://aac.asm.org/content/early/2014/12/16/AAC.04252-14.long

 

 

Chandrabali Ghose-Paul,MS,PhD, Chairperson of C. diff. Research and Development

 

Giving Thanks And Happy New Year - 2015

2014 is coming to a close and 2015 is just a few hours away.CDIFF2015wordss

As the New Year approaches, our thoughts turn gratefully to those who have helped us in our progress and the progress of our community possible. And in this spirit we say, simply and sincerely, thank you.

Thank you for everything big and small you do to help make the C Diff Foundation a better resource in the lives of others, a rewarding organization to work with, and for joining us in raising C. diff. awareness to the millions of families, healthcare providers, communities, and friends worldwide.

We are a giving Foundation and a lot of that giving is facilitated through each of you. Giving makes a difference and there are so many different ways to give. Whether it is through presentations at a conference, joining the Foundation’s volunteer program, or donating time in November for the “Raising C Diff Awareness” campaign in communities across the globe the partnered efforts and contributions are greatly appreciated. Through the many facets of giving and charitable support, the Foundation’s mission continues to move forward in educating, and advocating for C. diff. prevention, treatments, and environmental safety worldwide.

From all of us to all of you and your families, we send our best wishes for a happy, healthy, and successful 2015!

Thank you and Happy New Year.

C Diff Foundation’s “Raising C. diff. Awareness For Healthcare Providers” Educational DVD Released

Join the many healthcare professionals raising C.diff. awareness with their colleagues and staff worldwide.

This educational DVD is available through the website http://www.cdifffoundation.org and with a donation of $50.00 USD (includes shipping), you will receive one (1) DVD, twenty informational brochures, and a certificate of attendance to share with the attendees at each in-service session.

CDIFFDVD22 (2)

 

Access the “How You Can Help - Donate Today” fifth tab along the top of the first page of the website to enter the donation application.

Thank you for joining the Foundation in Raising C. diff. Awareness through educating and advocating for C. diff. prevention, treatments, and environmental safety worldwide.

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 2nd, 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

Antibiotic Resistance; India hospitals receive assistance how to track and tackle superbugs

An article published explaining the Antibiotic-Resistance and struggles being experienced in Indian hospitals.

The Center for Disease Dynamics, Economics & Policy, a Washington-based research center, is showing Indian hospitals how to track the trends of antibiotic-resistance on their premises.

It’s a breakthrough method that may eventually help hospitals implement strategies to tackle superbugs over the long term.

India is facing harsh criticism from the global community for its inability to tackle its superbug epidemic.

More than 58,000 infants died last year from bacterial infections that could not be treated, according to the New York Times.

“Until recently, this was very much a developed world problem. That’s where antibiotics were used and abused,” said Keith Klugman, director of the pneumonia program at the Bill & Melinda Gates Foundation. (Disclosure: BMGF funds TakePart World.) “But very rapidly, India is taking over the rest of the developed world as a focus of resistance.”

Indeed, antibiotics are sold indiscriminately across India. Researchers at Princeton University and CDDEP found it was the biggest consumer of antibiotics worldwide in 2010. Public health activist Abhay Bang blames antibiotic abuse on what he calls the “mind-set” of doctors and patients. “Patients want quick-fix medications,” Bang said. “Doctors in competitive private medical practices have no choice but to provide them.”

CDDEP’s solution currently focuses mainly on big, multi-specialty hospitals. The magic wand: the Drug Resistance Index. Developed by CDDEP director Ramanan Laxminarayan along with Klugman, the concept was first introduced in a paper in BMJ Open, a prominent open-access journal of medical science, in 2011.

DRI pools data about two crucial sets of information: how much and which antibiotics are being consumed to target a particular bacterial species or group of species, and how resistant that microbe is in a particular setting, such as a hospital room or a country overall. That information is then compressed into one figure on a scale of 0 to 1—think of it as a Dow Jones Index for bacterial resistance. A DRI of 0 means all infections caused by a pathogen are treatable with antibiotics available at the hospital; a DRI of 1 means none of the available antibiotics can tackle it, explains CDDEP researcher Suraj Pant.

“This index provides a quick, intuitive overview on the overall state of bacterial resistance and can be used to measure the effectiveness of interventions aimed at reducing antibiotic use or preventing infections in hospital settings,” said Pant, who is supervising the collaboration in India.

CDDEP is providing technical know-how to 12 hospitals in India to calculate DRI for five to six major pathogens on a pro bono basis. “We offer our expertise to whoever approaches us,” said Pant.

But what is this index really telling us? “The main power of DRI lies in trends over time,” Pant added. For example, if the DRI of E. coli—familiar to Americans as the cause of many outbreaks of food-borne illness—is 0.4 in 2014 and 0.6 in 2016 in a particular hospital, then that means the infections caused by the pathogen have become more difficult to treat.

Some medical experts are still not convinced about DRI’s usefulness. “We’re still figuring out what it means in the Indian context,” said Chand Wattal, honorary senior consultant in the department of microbiology at Sir Ganga Ram Hospital in New Delhi. The leading hospital has been calculating DRI on its own since 2011. “It doesn’t help with day-to-day patient management,” Wattal said. “It really is geared toward helping policymakers understand trends in microbial resistance.”

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

http://news.yahoo.com/yes-scared-antibiotics-may-just-stopped-working-india-233648115.html

Sending Warm Holiday Greetings

The holiday season is upon us; A time to share warm holiday greetings while reflecting upon the many individuals combating a C. difficile infection.

We especially call to mind those who have passed away from a Clostridium difficile infection and/or C. difficile involvement while fighting other diagnoses simultaneously.

The all-encompassing nature of chronic illness and its disruption of life and plans can elicit a wide range of emotions. These responses include: stress, grief, anger,fear,depression, and anxiety. Be kind to yourself. Take time for you during the holiday season.

Try experimenting with different ways of managing stress and painful emotions. When you find a technique that works, try to incorporate it into your daily or weekly routine. Some ideas include exercising, walking, yoga, listening to music, deep breathing exercise, meditation, cooking, reading, writing in a journal, and spending quality time with family and friends.

We would like to take this opportunity to say that during the year it has been truly appreciated to stand along-side the many patient focused and educational organizations, healthcare professionals, and scientists researching and developing new preventative measures, and treatments to combat C. diff. infections along with the long list of “superbugs.”

Through continued education and advocating for C. diff. infections and Healthcare-Associated Infections (HAI’s) positive effects are taking place in raising awareness in prevention, treatments, and environmental safety worldwide.

In 2015 we look forward to releasing newly developed tools for patients, families, healthcare professionals. and residents in every community while working toward a shared goal in witnessing a reduction of newly diagnosed C. diff. and Healthcare-Associated Infection (HAI’s) infections.

None of us can do this alone…..all of us can do this together.

Thank you for your continued support and from all of us at the C Diff Foundation, we wish you and your family warm holiday greetings.