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    Numerate Awarded Phase 1 NIH Grant to Support Design of New Therapies for Celiac Disease


    Scott Adams

    Celiac.com 03/19/2009 - Numerate Inc., a biotechnology company leveraging a novel drug engineering process to design lead-stage drug compounds, announced today it has received a Phase 1 grant from the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health (NIH). The Small Business Technology Transfer (STTR) award, entitled “Drug Engineering of Transglutaminase 2 Inhibitors,” will be used to support a research collaboration between Numerate and the laboratory of Chaitan Khosla, Ph.D., the Wells H. Rauser and Harold M. Petiprin Professor of Chemical Engineering and Chemistry at Stanford University.


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    “This NIH Phase 1 STTR award validates the attractiveness of Numerate’s drug engineering process for the design of new small molecule drugs,” stated John Griffin, Ph.D., Numerate’s chief scientific officer and principal investigator of the project. “In addition, it recognizes the potential of transglutaminase 2 inhibitors for the treatment of Celiac Sprue. Professor Khosla is a leader in Celiac disease research, and we are pleased to have the support of the NIH in our collaboration with him and his laboratory.”

    Professor Khosla, who will serve as co-investigator for the STTR research project, added, “Transglutaminase 2 is central to the pathophysiology of Celiac Sprue, and offers a compelling target for a disease for which no pharmacotherapy currently exists. I look forward to having Numerate apply its breakthrough technology to this important problem.”

    Celiac Sprue, also known as celiac disease, is an autoimmune disorder of the small intestine involving intolerance to gluten proteins found in wheat and other grains.

    About Numerate

    Numerate is a privately held biotechnology company that has developed and extensively validated a drug engineering process that rapidly and cost-effectively delivers small molecule drug candidates optimized for efficacy, safety, and patentability. Numerate’s drug engineering process combines advances in computer science, statistics, and molecular modeling to address, in parallel, the factors that determine the success and failure of a drug. Numerate applies this proprietary process to design and develop small molecule therapeutics in collaboration with a variety of partners in the pharmaceutical and biotechnology fields. For more information, please visit www.numerate.com.

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  • About Me

    In 1994 I was diagnosed with celiac disease, which led me to create Celiac.com in 1995. I created this site for a single purpose: To help as many people as possible with celiac disease get diagnosed so they can begin to live happy, healthy gluten-free lives. Celiac.com was the first site on the Internet dedicated solely to celiac disease. In 1998 I founded The Gluten-Free Mall, Your Special Diet Superstore!, and I am the co-author of the book Cereal Killers, and founder and publisher of Journal of Gluten Sensitivity.

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  • Related Articles

    Scott Adams
    The following is from a talk given at the Gluten Intolerance Group Annual Educational Seminar on April 1, 1995 by Dr. Alessio Fasano, Pediatric Gastroenterologist, University of Maryland School of Medicine which was also reported in the May 1995 issue of the GIG Newsletter. The findings of these experts indicate that the incidence of celiac disease in the general population could be as high as 1 in 300-500 people when one takes into account all forms of the disease. Here is a report of the meeting:
    The question which was brought up was How prevalent is celiac disease?. Although there is much data on the incidence of celiac disease that has been collected in Europe, there is almost no data from the United States. After compiling data on the incidence of celiac disease in Europe, something very unusual was noticed.
    Two cities in Europe - Malmo, Sweden and Copenhagen, Denmark, which lie only 20 miles apart, seem to have a large difference in the incidence of celiac disease. In Malmo, the incidence was 1 in 500 people, which is quite high, while in Copenhagen it was 1 out of 11,000, which is much lower. Keep in mind that these figures represent only those patients whose celiac disease had been clinically diagnosed by a small intestinal biopsy.
    There are three major ways in which celiac disease presents itself in patients. The first are the asymptomatic patients who have no symptoms whatsoever, but exhibit damage to their small intestines upon examination. The second are patients with the latent form which means they have blood-tested positive for celiac disease, nut no tissue damage has occurred yet. This form will later develop into the typical or atypical forms. The third is the typical presentation, which shows up when the patient is between 6 and 18 months old. These patients develop the classic symptoms: diarrhea, fatty stools, lack of weight gain, irritability and anorexia. Typical presentations of celiac disease are rather rare in comparison to the other forms, which leads to the overall under-diagnosis of celiac disease, and is illustrated by the following statistics:
    Clinical Presentation
    Cumulative Prevalence
    Classical (Typical) Form
    1 in 2500
    Atypical - Late Onset Form 1 in 1500 Asymptomatic Form 1 in 1000 Latent Form (celiac disease Associated with other Diseases) 1 in 300-500* *Researchers in Italy have reached the conclusion that the incidence of celiac disease would be more like 1 person with celiac sprue for every 300 to 500 in the general population, when looking at all forms of the disease.
    Serological screening using anti-gliadin and anti-endomysial antibodies allows doctors to obtain a much more accurate picture of the actual number of people affected by celiac disease. In Europe, for example, researchers have found a much higher incidence of celiac disease than expected (1 in 300!), and it is spread uniformly throughout the population. Researchers re-tested the cities of Malmo and Copenhagen and found the incidence in Copenhagen to be 1 in 300. The difference between the two cities is in the clinical presentation of the disease. In Denmark there were more people who exhibited symptoms of osteoporosis, dermatitis herpetiformis, short stature and other atypical presentations. The awareness of physicians that these presentations could be celiac disease was very low.
    The discussion then turned to the United States:
    The next question discussed at the meeting was: What is the true incidence of celiac disease in the United States? The researchers believe that the recently discovered antibody markers will help in answering this question. According to them, we should soon be able to tell whether the low estimates for celiac disease in the US are fact, or if atypical presentations of celiac disease have been overlooked, thus resulting in the extraordinary low level of diagnosed celiacs. A study conducted at the University of Maryland looked at 159 children with atypical symptoms (short stature, poor weight gain, chronic diarrhea, abdominal pain, asymptomatic relatives of celiacs).
    The following chart summarizes the study:
    Study: 159 Children With Atypical Symptoms*
    Symptom Group No. Screened Positive Screen Negative Screen Short stature 78 7 71 Poor weight gain 21 6 15 Chronic diarrhea 17 1 16 Abdominal Pain 8 1 7 Asymptomatic 35 2 33 *Please keep in mind that this study was not based on a random cross-section of the population, but, rather on children who already exhibited atypical symptoms.
    It is crucial to make the correct diagnosis, and to keep even asymptomatic people free of gluten . This is due to the associated morbidity, such as chronic ill health. With regard to the pediatric population, permanent stunted growth may result from a misdiagnosis. If the physicians fail to make a timely diagnosis, there is no time for catch-up growth, and the individual may be short forever. The same is true with skeletal disorders such as osteoporosis. Everyone with celiac sprue who experiences osteoporosis must place a certain amount of blame on the physician for not diagnosing celiac disease in time to prevent such demineralization.

    Jefferson Adams
    Celiac.com 09/28/2012 - Two researchers recently set out to study gluten sensitivity in people without celiac disease. The study was conducted by A. Di Sabatino A, and G.R. Corazza of the Centro per lo Studio e la Curia della Mallatia Celiaca at the Fondazione IRCCS Policlinico San Matteo at the University of Pavia in Italy.
    A number of studies support the existence non-celiac gluten sensitivity, which can be marked by both internal and external symptoms in individuals with normal small-bowel mucosa and negative results on serum anti-transglutaminase and anti-endomysial antibody testing. These symptoms are very similar to traditional celiac disease symptoms, and seem to improve or disappear with the adoption of a gluten-free diet.
    Although researchers are currently debating the clinical aspects of this condition, studies indicate that the prevalence of non-celiac gluten sensitivity in the general population may be many times higher than that of celiac disease.
    Further study and diagnosis of non-celiac gluten sensitivity is being hindered by the lack of a clear definition of the condition. The lack of a clear definition is due at least in part to the fact that there is no single known cause, and the symptoms are likely influenced by a variety of factors.
    More work needs to be done to establish a clear definition for non-celiac gluten intolerance, and to delineate diagnostic protocols. The research team notes that if it turns out that non-celiac gluten sensitivity does in fact have multiple triggers, then treatment options should vary accordingly.
    However, any treatment would likely include a gluten-free diet.
    Source:
    Ann Intern Med. 2012 Feb 21;156(4):309-11.

    Jefferson Adams
    Celiac.com 11/22/2013 - Timing of gluten introduction has been associated with the risk of celiac disease in children, but the best time window for gluten introduction had remained unknown.
    In order to determine the optimal time window for gluten introduction in children, a team of researchers recently set out to assess the effect of age at first gluten consumption on the risk of celiac disease, and to adjust their data for continued breastfeeding.
    The research team included Ketil Størdal, MD, PhD, Richard A. White, PhD, and Merete Eggesbø, MD, PhD. They are variously affiliated with the Norwegian Institute of Public Health, Oslo, Norway; and Østfold Hospital Trust in Fredrikstad, Norway.
    For their study, the team used the Norwegian Mother and Child Cohort Study, a prospective birth cohort including 107 000 children, questionnaires to identify celiac disease, and linkage to the Norwegian Patient Register.
    They recorded results of reported gluten introduction monthly from 0 to 6 months of age, and breastfeeding from 0 to 18 months.
    After exclusion of cases with insufficient information, they found 324 children with celiac disease from a group of 82,167 useful for their analyses.
    Gluten was introduced before or at 4 months in 8.0%, 5 to 6 months in 45.3%, and after 6 months in 46.6%, whereas continued breastfeeding was stable at ∼78% at 6 months age.
    They found celiac disease in 3.68 per 1000 infants with gluten introduction at 5 to 6 months compared with 4.15 per 1000 with late and 4.24 per 1000 with early gluten introduction.
    After adjustment for the child’s age and gender, breastfeeding, and maternal celiac disease, delayed gluten introduction was associated with an increased risk of celiac disease (adjusted odds ratio, 1.27 [95% confidence interval, 1.01–1.65], P = .045).
    Breastfeeding >12 months was also associated with increased risk (adjusted odds ratio, 1.49 [95% confidence interval, 1.01–2.21], P = .046).
    Overall, the team found an increased risk of celiac disease in children introduced to gluten after 6 months, and a higher risk in children breastfed beyond 12 months of age.
    Source:
    Pediatrics, October 7, 2013 (doi: 10.1542/peds.2013-1752)

    Jefferson Adams
    Celiac.com 07/02/2014 - Each year, non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, acetaminophen, and aspirin, send more than 100,000 people to the hospital, and cause over 16,000 deaths. These drugs are marketed under brand names such as Advil and aspirin, among others.
    In some ways, these findings are unsurprising. Studies from as far back as the 1980s have shown that “NSAIDs…disrupt intestinal integrity and long term treatment leads to inflammation of the small intestine.”
    Recently, a group of researchers reviewed study data from the last 20 years, and found that NSAIDs increase the likelihood of leaky gut syndrome.
    According to one study by the National Instituted of Health (NIH), all “…conventional NSAIDs studied were equally associated with small intestinal inflammation apart from aspirin…” and “intestinal permeability changes were significantly more pronounced” with some of the tests.
    Additional data showed that NSAIDs cause intestinal damage when taken in conjunction with exercise. This is significant, because this was the first study to show that “ibuprofen aggravates exercise-induced small intestinal injury and induces gut barrier dysfunction in healthy individuals.” The team concluded that NSAID use by athletes “is not harmless and should be discouraged.”
    This finding is significant for people with celiac disease, or for those at risk of celiac disease, because permeable and inflamed intestines permit leakage of infectious or toxic substances into the blood stream. This can trigger an adverse immune response, and interfere with proper digestion and nutritional absorption.
    Gut leakage can also lead to a number of other health problems, including diabetes, asthma, and even heart failure.
    Source:
    thedailybeast.com

  • Recent Articles

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    Bakery On Main started in the small bakery of a natural foods market on Main Street in Glastonbury, Connecticut. Founder Michael Smulders listened when his customers with Celiac Disease would mention the lack of good tasting, gluten-free options available to them. Upon learning this, he believed that nobody should have to suffer due to any kind of food allergy or dietary need. From then on, his mission became creating delicious and fearlessly unique gluten-free products that were clean and great tasting, while still being safe for his Celiac customers!
    Premium ingredients, bakeshop delicious recipes, and happy customers were our inspiration from the beginning— and are still the cornerstones of Bakery On Main today. We are a fiercely ethical company that believes in integrity and feels that happiness and wholesome, great tasting food should be harmonious. We strive for that in everything we bake in our dedicated gluten-free facility that is GFCO Certified and SQF Level 3 Certified. We use only natural, NON-GMO Project Verified ingredients and all of our products are certified Kosher Parve, dairy and casein free, and we have recently introduced certified Organic items as well! 
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    Jefferson Adams
    Celiac.com 06/20/2018 - Currently, the only way to manage celiac disease is to eliminate gluten from the diet. That could be set to change as clinical trials begin in Australia for a new vaccine that aims to switch off the immune response to gluten. 
    The trials are set to begin at Australia’s University of the Sunshine Coast Clinical Trials Centre. The vaccine is designed to allow people with celiac disease to consume gluten with no adverse effects. A successful vaccine could be the beginning of the end for the gluten-free diet as the only currently viable treatment for celiac disease. That could be a massive breakthrough for people with celiac disease.
    USC’s Clinical Trials Centre Director Lucas Litewka said trial participants would receive an injection of the vaccine twice a week for seven weeks. The trials will be conducted alongside gastroenterologist Dr. James Daveson, who called the vaccine “a very exciting potential new therapy that has been undergoing clinical trials for several years now.”
    Dr. Daveson said the investigational vaccine might potentially restore gluten tolerance to people with celiac disease.The trial is open to adults between the ages of 18 and 70 who have clinically diagnosed celiac disease, and have followed a strict gluten-free diet for at least 12 months. Anyone interested in participating can go to www.joinourtrials.com.
    Read more at the website for Australia’s University of the Sunshine Coast Clinical Trials Centre.

    Source:
    FoodProcessing.com.au

    Jefferson Adams
    Celiac.com 06/19/2018 - Could baking soda help reduce the inflammation and damage caused by autoimmune diseases like rheumatoid arthritis, and celiac disease? Scientists at the Medical College of Georgia at Augusta University say that a daily dose of baking soda may in fact help reduce inflammation and damage caused by autoimmune diseases like rheumatoid arthritis, and celiac disease.
    Those scientists recently gathered some of the first evidence to show that cheap, over-the-counter antacids can prompt the spleen to promote an anti-inflammatory environment that could be helpful in combating inflammatory disease.
    A type of cell called mesothelial cells line our body cavities, like the digestive tract. They have little fingers, called microvilli, that sense the environment, and warn the organs they cover that there is an invader and an immune response is needed.
    The team’s data shows that when rats or healthy people drink a solution of baking soda, the stomach makes more acid, which causes mesothelial cells on the outside of the spleen to tell the spleen to go easy on the immune response.  "It's most likely a hamburger not a bacterial infection," is basically the message, says Dr. Paul O'Connor, renal physiologist in the MCG Department of Physiology at Augusta University and the study's corresponding author.
    That message, which is transmitted with help from a chemical messenger called acetylcholine, seems to encourage the gut to shift against inflammation, say the scientists.
    In patients who drank water with baking soda for two weeks, immune cells called macrophages, shifted from primarily those that promote inflammation, called M1, to those that reduce it, called M2. "The shift from inflammatory to an anti-inflammatory profile is happening everywhere," O'Connor says. "We saw it in the kidneys, we saw it in the spleen, now we see it in the peripheral blood."
    O'Connor hopes drinking baking soda can one day produce similar results for people with autoimmune disease. "You are not really turning anything off or on, you are just pushing it toward one side by giving an anti-inflammatory stimulus," he says, in this case, away from harmful inflammation. "It's potentially a really safe way to treat inflammatory disease."
    The research was funded by the National Institutes of Health.
    Read more at: Sciencedaily.com

    Jefferson Adams
    Celiac.com 06/18/2018 - Celiac disease has been mainly associated with Caucasian populations in Northern Europe, and their descendants in other countries, but new scientific evidence is beginning to challenge that view. Still, the exact global prevalence of celiac disease remains unknown.  To get better data on that issue, a team of researchers recently conducted a comprehensive review and meta-analysis to get a reasonably accurate estimate the global prevalence of celiac disease. 
    The research team included P Singh, A Arora, TA Strand, DA Leffler, C Catassi, PH Green, CP Kelly, V Ahuja, and GK Makharia. They are variously affiliated with the Division of Gastroenterology and Hepatology, Beth Israel Deaconess Medical Center, Boston, Massachusetts; Lady Hardinge Medical College, New Delhi, India; Innlandet Hospital Trust, Lillehammer, Norway; Centre for International Health, University of Bergen, Bergen, Norway; Division of Gastroenterology and Hepatology, Beth Israel Deaconess Medical Center, Boston, Massachusetts; Gastroenterology Research and Development, Takeda Pharmaceuticals Inc, Cambridge, MA; Department of Pediatrics, Università Politecnica delle Marche, Ancona, Italy; Department of Medicine, Columbia University Medical Center, New York, New York; USA Celiac Disease Center, Columbia University Medical Center, New York, New York; and the Department of Gastroenterology and Human Nutrition, All India Institute of Medical Sciences, New Delhi, India.
    For their review, the team searched Medline, PubMed, and EMBASE for the keywords ‘celiac disease,’ ‘celiac,’ ‘tissue transglutaminase antibody,’ ‘anti-endomysium antibody,’ ‘endomysial antibody,’ and ‘prevalence’ for studies published from January 1991 through March 2016. 
    The team cross-referenced each article with the words ‘Asia,’ ‘Europe,’ ‘Africa,’ ‘South America,’ ‘North America,’ and ‘Australia.’ They defined celiac diagnosis based on European Society of Pediatric Gastroenterology, Hepatology, and Nutrition guidelines. The team used 96 articles of 3,843 articles in their final analysis.
    Overall global prevalence of celiac disease was 1.4% in 275,818 individuals, based on positive blood tests for anti-tissue transglutaminase and/or anti-endomysial antibodies. The pooled global prevalence of biopsy-confirmed celiac disease was 0.7% in 138,792 individuals. That means that numerous people with celiac disease potentially remain undiagnosed.
    Rates of celiac disease were 0.4% in South America, 0.5% in Africa and North America, 0.6% in Asia, and 0.8% in Europe and Oceania; the prevalence was 0.6% in female vs 0.4% males. Celiac disease was significantly more common in children than adults.
    This systematic review and meta-analysis showed celiac disease to be reported worldwide. Blood test data shows celiac disease rate of 1.4%, while biopsy data shows 0.7%. The prevalence of celiac disease varies with sex, age, and location. 
    This review demonstrates a need for more comprehensive population-based studies of celiac disease in numerous countries.  The 1.4% rate indicates that there are 91.2 million people worldwide with celiac disease, and 3.9 million are in the U.S.A.
    Source:
    Clin Gastroenterol Hepatol. 2018 Jun;16(6):823-836.e2. doi: 10.1016/j.cgh.2017.06.037.

    Jefferson Adams
    Celiac.com 06/16/2018 - Summer is the time for chips and salsa. This fresh salsa recipe relies on cabbage, yes, cabbage, as a secret ingredient. The cabbage brings a delicious flavor and helps the salsa hold together nicely for scooping with your favorite chips. The result is a fresh, tasty salsa that goes great with guacamole.
    Ingredients:
    3 cups ripe fresh tomatoes, diced 1 cup shredded green cabbage ½ cup diced yellow onion ¼ cup chopped fresh cilantro 1 jalapeno, seeded 1 Serrano pepper, seeded 2 tablespoons lemon juice 2 tablespoons red wine vinegar 2 garlic cloves, minced salt to taste black pepper, to taste Directions:
    Purée all ingredients together in a blender.
    Cover and refrigerate for at least 1 hour. 
    Adjust seasoning with salt and pepper, as desired. 
    Serve is a bowl with tortilla chips and guacamole.