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.
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*In The News* Seres Health, a clinical-stage therapeutics company developing novel treatments for diseases related to the human microbiome, today announced that it has received a Notice of Allowance from the U.S. Patent and Trademark Office for a pharmaceutical composition patent application that covers its lead product candidate, SER-109, which is currently in clinical testing for the treatment of recurrent C. difficile.
The patent to be issued from this allowed application entitled “Synergistic Bacterial Compositions and Methods of Production and Use Thereof” carries a patent term to at least 2033, and specifically claims therapeutic compositions of bacterial populations that are cytotoxic or cytostatic to pathogens, including in combination with anti-bacterial, anti-fungal, anti-parasitic and anti-viral agents. Similar applications have been filed with the Patent Cooperation Treaty (PCT).
“This notice of allowance is an important step forward not only for Seres but for the microbiome field in general,” said Dr. Roger J. Pomerantz, President, CEO and Chairman of Seres Health. “We are driven to obtaining strong patent protection for SER-109, as well as our other clinical candidates, as we continue development with the goal of bringing our first-in-field product to patients.”
The forthcoming patent, published as US Patent Publication 20140147425, is the first to emerge from the company’s patent portfolio that includes over 30 applications. Utilizing its proprietary platform for microbiome-based drug discovery, Seres rationally designs therapeutics based on the ecological nature of the microbiome, catalyzing a shift from a diseased microbiome to one of health. SER-109, the first Seres Ecobiotic® product tested in clinical studies, has demonstrated clinical efficacy for recurrent C. Difficile infections. The company is rapidly growing its pipeline of Ecobiotic® therapeutics for other indications.
SER-109 is the first Seres Health Ecobiotic® product currently in clinical testing for the treatment of Clostridium Difficile Infection (CDI). SER-109 was developed utilizing the Seres Health Microbiome Therapeutics platform to understand the ecologies of disease associated with CDI and identify an efficient means to catalyze a shift to health. CDI is a rapidly growing problem associated with antibiotic use. Over 700,000 cases of CDI are reported each year, leading to more than 250,000 hospitalizations and over 14,000 fatalities annually in the U.S. alone. Over 200,000 of these patients have at least one recurrence, for which no drugs are currently approved. SER-109 has demonstrated clinical efficacy, and a late-stage trial is expected to start by the end of 2014.
About Seres Health
Seres Health is a clinical-stage therapeutics company focused on discovering and developing Ecobiotic® therapeutic products, novel drugs to treat important diseases by targeting the underlying biology of the human microbiome. Founded by Flagship VentureLabs, Seres is pioneering the first therapeutics that catalyze a shift to health by augmenting the biology of the microbiome. Current candidates span infectious, metabolic, and inflammatory diseases. Seres recently announced a research agreement with Mayo Clinic and has received over $20 million in funding to date. For more information, please visit www.sereshealth.com.
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The process of delivering stool bacteria from a healthy donor to a patient suffering from intestinal infection with the bacterium Clostridium difficile works by restoring healthy bacteria and functioning to the recipient’s gut, according to a study published this week in mBio®, the online open-access journal of the American Society for Microbiology.
The study provides insight into the structural and potential metabolic changes that occur following fecal transplant, says senior author Vincent B. Young, MD, PhD, an associate professor in the Department of Internal Medicine/Infectious Diseases and the Department of Microbiology & Immunology at the University of Michigan in Ann Arbor. The transplants, which have been successful at curing more than 90 percent of recipients, have been used successfully since the 1950s, he says, though it hasn’t been clear how they work to recover gut function.
“The bottom line is fecal transplants work, and not by just supplying a missing bug but a missing function being carried out by multiple organisms in the transplanted feces,” Young says. “By restoring this function, C. difficile isn’t allowed to grow unchecked, and the whole ecosystem is able to recover.”
Young and colleagues used DNA sequencing to study the composition and structure of fecal microbiota (bacteria) in stool samples from 14 patients before and two to four weeks after fecal transplant. In 10 of the patients, researchers also compared stool samples before and after transplant to samples from their donors.
All transplant patients, treated at the Essentia Health Duluth Clinic in Minnesota, had a history of at least two recurrent C. difficile infections following an initial infection and failed antibiotic therapy.
Studying families of bacteria in the samples, investigators found marked differences among donor, pre-transplant and post-transplant samples. However, those from the donors and post-transplant patients were most similar to each other, indicating that the transplants at least partially returned a diverse community of healthy gut bacteria to the recipients. While not as robust as their donors, the bacterial communities in patients after transplant showed a reduced amount of Proteobacteria, which include a variety of infectious agents, and an increased amount of Firmicutes and Bacteroidetes bacteria typically found in healthy individuals, compared to their pre-transplant status.
Then, using a predictive software tool, researchers analyzed the relationship between the community structure of the micoorganisms and their function, presumably involved in maintaining resistance against CDI.
They identified 75 metabolic/functional pathways prevalent in the samples. The samples taken from patients before transplant had decreased levels of several modules related to basic metabolism and production of chemicals like amino acids and carbohydrates, but were enriched in pathways associated with stress response, compared to donor samples or post-transplant samples.
CDI has significantly increased during the past decade, Young says, with previous studies estimating there are more than 500,000 cases of CDI in the United States annually, with health care costs ranging from $1.3 billion to $3.4 billion. Up to 40 percent of patients suffer from recurrence of disease following standard antibiotic treatment. In a healthy person, gut microorganisms limit infections but antibiotics are believed to disrupt the normal structure of these microoganisms, rendering the gut less able to prevent infection with C. difficile.
Further identification of the specific microorganisms and functions that promote resistance of bacterial colonization, or growth, may aid in the development of improved CDI treatments, Young says: “If we can understand the functions that are missing, we can identify supplemental bacteria or chemicals that could be given therapeutically to help restore proper gut function.”
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The study was supported by the National Institutes of Health, the Michigan Gastrointestinal Peptide Research Center, and the Essentia Health Foundation in Duluth, Minn.
mBio® is an open access online journal published by the American Society for Microbiology to make microbiology research broadly accessible. The focus of the journal is on rapid publication of cutting-edge research spanning the entire spectrum of microbiology and related fields. It can be found online at http://mbio.asm.org.
The American Society for Microbiology is the largest single life science society, composed of over 39,000 scientists and health professionals. ASM’s mission is to advance the microbiological sciences as a vehicle for understanding life processes and to apply and communicate this knowledge for the improvement of health and environmental and economic well-being worldwide.
Recurrence has been identified by The European Society of Clinical Microbiology and Infectious Diseases (ESCMID) as the most important problem in the treatment of CDI.
New data presented at the 24th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) demonstrates that fidaxomicin, when used first-line, is clinically effective and provides cost savings for the treatment of potentially fatal Clostridium difficile infection (CDI). Treatment with fidaxomicin led to a reduction in recurrence for patients with CDI and a saving of over £48,000 to the UK’s NHS versus standard of care treatment (vancomycin or metronidazole).
The study, conducted at St George’s Hospital in London, England, is the first of its kind and looks at a year’s experience using fidaxomicin as a first-line treatment for all adults confirmed to have CDI, including populations not previously studied in randomised controlled Phase III trials., Data collected from a total of 62 patients treated with fidaxomicin during the 12 month evaluation period were compared with those from a retrospective cohort treated with standard of care (vancomycin or metronidazole) during the previous 12 month period.
Only 6% of patients treated with fidaxomicin had a recurrence of CDI, within 28 days of end of therapy, compared with a 20% recurrence rate with vancomycin/metronidazole in the preceding year. Recurrence is a major challenge in CDI treatment, with previous studies reporting that patients who have already had one recurrence, have a 40% risk of a further episode of CDI.Importantly, in this ‘real world’ study, there were no second recurrences reported in those treated with fidaxomicin. Hence, the observed reduction in recurrence rates and reduced hospital stays since the introduction of fidaxomicin as first-line treatment for CDI has culminated in overall cost savings.
Commenting on the findings, Dr. Tim Planche, lead investigator and Consultant Microbiologist, St George’s Hospital said: “We decided to start using fidaxomicin first-line over a year and a half ago for all cases of Clostridium difficile infection at St George’s, after the exciting data reported in clinical trials showed reduction in recurrence of infection. Having looked at our data we are very pleased to see that we find the same effects occurring in our own “real world” patients. Our team have also looked at the cost-effectiveness of using fidaxomicin and we are assured of the cost benefits of continuing to use this drug. From our experience of using this drug we are very happy to continue using it first-line and that it is worth other hospitals considering as part of their strategy to treat and control Clostridium difficile infection.”
Based on the findings of this landmark study, The Drugs and Therapeutics Committee for the hospital have upheld their recommendation for the use of fidaxomicin as a first-line therapy for all adult patients with CDI.
CDI is one of the most common causes of antibiotic-associated diarrhea and severe cases can lead to bowel surgery and even death. Hospital patients with CDI are up to three times more likely to die in hospital (or within a month of infection) than those without CDI.,Recurrence is a major challenge in CDI treatment, 25% of CDI patients suffer a recurrence within one month,,and patients who have already had one recurrence have a 40% risk of a further episode of CDI.
Commenting on the findings, Professor Oliver Cornely, University Hospital Cologne, Germany said: “One of the biggest challenges to optimal CDI management is recurrence, therefore the significant reduction in disease recurrence by fidaxomicin, compared with vancomycin, is an important step in reducing the morbidity and possibly mortality associated with CDI. The treatment for CDI had remained largely unchanged for 20 years. This real life data demonstrates a treatment advance that can improve patient outcomes and reduce the significant burden of this disease, which will hopefully lead to improved management of CDI in clinical practice.”
These results represent the interim findings of a larger cohort of real world data being collected and analysed from across the UK to assess the effectiveness of fidaxomicin. Data reporting from additional study centres are expected to be presented later in the year.
About Astellas Pharma Europe Ltd.
Astellas Pharma Europe Ltd., located in the UK, is the European Headquarters of Tokyo-based Astellas Pharma Inc. Astellas is a pharmaceutical company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceuticals. As a global company, Astellas is committed to combining outstanding research and development (R&D) and marketing capabilities to continue to grow in the world pharmaceutical market. Astellas Pharma Europe Ltd. manages 21 affiliate offices located across Europe, the Middle East and Africa. In addition, the Company has an R&D site and three manufacturing plants in Europe. The company employs approximately 4,300 staff across these regions. For more information about Astellas Pharma Europe, please visit http://www.astellas.eu/.
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2. Planche T, et al. Cost-effectiveness of fidaxomicin as first-line treatment for Clostridium difficile infection. Abstract presented at ECCMID 2014.
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What can you do while experiencing symptoms of diarrhea?
Liquids Drink plenty of liquids between meals to avoid dehydration. Water, broth, gelatin, ices, and sports drinks are all good choices.
Room temperature Some people tolerate liquids at room temperature better than those served hot or cold.
Sugar-free foods Avoid sugar-free foods when you have diarrhea. The sugar alcohols used to sweeten these foods, such as sorbitol and xylitol, can worsen diarrhea.
Dairy products Do not consume dairy products when symptoms are most severe. Add low-fat or fat-free milk back into your diet slowly.
Small meals Have small meals and snacks, rather than big meals.
Bland foods It is recommended that you choose bland foods when you have diarrhea.
Good choices include:
Canned soft fruits
Cooked hot cereals
Smooth nut butters
Foods to avoid Do not choose foods that are greasy, fried, or fatty. Do not add butter, oil, or other fats to your foods. Certain foods tend to cause discomfort for many patients, including:
Fried or fatty meats
Raw fruits (except bananas and melon)
Grains Choose grains that contain less than 2 grams of fiber/serving.
* CLEAR LIQUID DIETS are only to be followed for three (3) days. If adequate
nutrition or hydration can not be maintained, please contact the Physician and health
care professionals promptly and seek medical attention.
Meats, chicken, and fish Select lean meats, chicken, and fish.
Yogurt Patients with diarrhea caused by antibiotics may benefit form adding yogurt to their diet.
When should the physician be notified? Call your doctor if you:
Have mucus, blood, or pus in your stools
Have diarrhea lasting longer than 2 to 3 days
Have not urinated in 12 hours
Have severe pain or abdominal cramping
Are vomiting and experiencing diarrhea at the same time
Have a chronic illness, such as diabetes
Have a high fever (more than 101º F)
Experience rapid breathing, fever, or dizziness
If you have traveled to a foreign country, or have taken an antibiotic recently or in the past two/three months, or have developed diarrhea upon your return from any visit out of your immediate area.
Eat and drink whatever you think will work best for you
Frequent hand-washing breaks and for a minimum of twenty (20) seconds, before exiting a restroom, before/after eating, before/after entering a patients room, before/after wearing gloves during patient care, after changing diapers, after grooming and handling pets and Wash hands often.
Eat and drink small portions, gradually increasing your diet as tolerated