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    Scott Adams
    A little boy with a severe seizure disorder had his wish to have a special bike of his own granted through national children’s charity Kids Wish Network.
    Champaign, IL, August 14, 2010 --(PR.com)-- As a child, Joshua was diagnosed with having Intractable Epilepsy, a disorder in which he experiences seizures that are completely uncontrollable; he currently endures around four major seizures a day. Over the years, Joshua’s doctors have tried well over 10 different seizure medications to try and regulate his condition, but none have worked, including the 3 he is currently taking.
    Because of the severity of his condition, Joshua also suffers from developmental delays that have impaired his motor skills to the point where he cannot do much of anything without assistance; his communication skills are very limited. In addition, Joshua was diagnosed with having Celiac Disease, which is a condition that negatively affects his digestive tract when he eats foods that contain gluten. Because of this, Joshua must follow a strict diet that excludes the many foods that have gluten in them, including all wheat-based foods.
    It was a teacher of Joshua’s who told his mother Janet about national children’s charity Kids Wish Network and the wishes they grant to kids like Joshua who are suffering from life-threatening illnesses; Joshua’s mother decided to give them a call.
    Of all the things he could want, all Joshua wanted was a special bike so that he could ride beside his grandfather during the bike rides he enjoys so much; he previously had to ride behind his grandfather in a special seat.
    With an amazing amount of local support from the Westminster Presbyterian Church and the Champaign Firefighters Local 1260, Joshua’s Kids Wish Network wish coordinator arranged for a special side by side “trike” to be sent directly to his house.
    Janet says that her son Joshua took to the brand new side by side bike immediately.
    “It’s very amazing for him because it usually takes him a while to get used to new things, but since he’s gotten the bike, he’s actually requested going for a ride… he goes out to the garage and stands by it. It’s amazing for him,” said Janet.
    “He really likes being right up there next to his grandpa and seeing everything…he’ll even lean over and pat him [his grandpa] on his arm or kiss him…Joshua’s smiling a lot and he’s even laughed a few times, too! This is not usual. I mean, before (on rides) he’d sometimes smile, but not like this.”
    Not only is the “wish bike” something to bring a smile to Joshua’s face, but it is also a chance for Joshua to learn things he might not have ever have had the chance to learn.
    According to Janet, “It’s going to grow with him. It’s a possibility for him to learn to pedal… he’s even put his hand on the handlebars several times, imitating his grandpa. He’s interested and it’s wonderful.”
    Kids Wish Network would like to thank the following for helping to make Joshua’s wish extra special: Westminster Presbyterian Church, Champaign Firefighters Local 1260 and the Worksman Trading Corporation.
    Kids Wish Network is a nationally recognized non-profit organization dedicated to infusing hope, creating happy memories, and improving the quality of life for children in crisis. Every child deserves a chance at happiness; a wish is just a way of bringing them that joy. If you would like to sponsor a child’s wish or if you know a child who is suffering from a life-threatening illness and may be in need of Kids Wish Network’s wish granting services, please call 727-937-3600 or toll free 888-918-9004. For more information on Kids Wish Network, visit their website at www.kidswishnetwork.org


    Jefferson Adams
    Efficacy Data from Phase 2a Trial of ALV003 in Celiac Disease Patients
    Celiac.com 12/13/2011 - Alvine Pharmaceuticals, Inc. has announced that efficacy data from its Phase 2a clinical trial of ALV003 shows that oral ALV003, administered as part of a gluten free diet, reduced gluten-induced intestinal mucosal damage in people with well-controlled celiac disease.
    Alvine presented the study findings in a session of the 19th United European Gastroenterology Week (UEGW) in Stockholm.
    "These results are groundbreaking as they demonstrate for the first time, in a controlled clinical trial, that a drug has the potential to diminish gluten-induced injury in celiac disease patients," says Markku Maeki, M.D., chair and professor of pediatrics at the University of Tampere and Tampere University Hospital in Finland, and coordinating investigator of the ALV003 Phase 2a trial.
    Most people with celiac disease control their disease by following the gluten-free diet that is the only current treatment.
    Of those, many still suffer gluten-related discomfort and gut damage. In fact, Mr. Maeki adds, "up to 60 percent of adult celiac disease patients continue to experience symptoms and up to 80 percent continue to have persistent intestinal inflammation despite adhering to a strict gluten-free diet."
    Since gluten is so common in food processing, it's almost impossible to avoid ingesting tiny amounts of gluten, even for people with celiac disease.
    Gluten contamination commonly occurs via cross-contamination in the processing of food products, incorrect or inaccurate labeling, lack of dietary education and awareness, and even due to willful back-sliding on the part of otherwise faithful gluten-free dieters.
    According to Dr. Maeki, non-dietary treatment options that either eliminate, or significantly reduce gluten ingestion by those attempting a gluten-free diet are needed, "ecause it is all but impossible to avoid gluten, even while adhering to a gluten-free diet, celiac patients are at continued risk for gastrointestinal symptoms and potentially serious long-term medical consequences."
    The study is constructed as a double-blind, placebo-controlled Phase 2a clinical trial on 41 adults with well-documented celiac disease, who had followed on a gluten-free diet for one or more years. Study participants were randomly given ALV003 or a placebo each day for six weeks. At the same time, they were given 2g of gluten in the form of bread crumbs.
    Each member of the study received small bowel biopsy at the beginning of the trial, and then again after six weeks of daily gluten challenge.
    The study's primary endpoint was intestinal mucosal morphometry (villus height:Crypt depth)(or vh:celiac disease) measured at baseline and at six weeks.
    Secondary endpoints included intraepithelial lymphocyte (IEL) density (cells/mm), gastrointestinal symptoms as measured by Gastrointestinal Symptom Rating Scale (GSRS) scores, celiac serologies, safety and tolerability.
    The study was statistically powered for the primary endpoint of change in Vh:celiac disease with six weeks of gluten exposure. Results from 34 celiac disease patients eligible for analysis showed that after six weeks:
    --  Biopsy data demonstrated significantly less small intestinal mucosal injury as measured by Vh:celiac disease in patients treated with ALV003 than in placebo-treated patients (p=0.0133).
    --  IELs, including CD3+ and CD3+ alpha/beta and gamma/delta subsets, which measure inflammatory response, were essentially unchanged in the ALV003-treated patients but significantly increased in the placebo-treated patients.
        ------------------------------------------------------------------------
                                        Change from Week 0                     p value
                                             to Week 6
        ------------------------------------------------------------------------
                               ALV003 (n=16)      Placebo (n=18)
        ------------------------------------------------------------------------
         Vh:celiac disease                                -0.2                -0.8         0.0133
        ------------------------------------------------------------------------
          CD3+ IELs                      +2.4               +30.8        0.0152
        ------------------------------------------------------------------------
        CD3 alpha/beta IELs         -1.8               +24.2         0.003
        ------------------------------------------------------------------------
        CD3 gamma/delta IELs    +0.5               +10.9         0.003
        ------------------------------------------------------------------------
                
    --  Overall GSRS scores and scores for indigestion and abdominal pain symptoms were lower in ALV003-treated patients than in placebo-treated patients, although the results were not statistically significant.
    --  No statistically significant changes were observed in celiac disease serology tests between the ALV003 and placebo-treated patients, although positive trends were observed for tissue transglutaminase (tTG) and deamidated gliadin peptide (DGP) antibodies in the ALV003-treated group, a measure of immune responsiveness.
    --  No serious adverse events were reported. Non-serious adverse events consistently occurred more frequently in the placebo-treated patients. Adverse events that occurred in 10 percent or more patients included abdominal distention, flatulence, eructation, abdominal pain and diarrhea.

    Source:

    http://www.marketwatch.com/story/alvine-pharmaceuticals-presents-additional-efficacy-data-from-phase-2a-trial-of-alv003-in-celiac-disease-patients-2011-10-24

    Jefferson Adams
    Celiac.com 09/16/2013 - Until recently, researchers thought celiac disease was mainly a problem in Northern Europe and Australasia, and uncommon in North America and the Middle East. However, with better data, researchers now regard celiac disease to be equally common in all these places.
    Celiac disease is still generally seen as rare in Asia and Sub-Saharan Africa, but a team of researchers wanted to get a better idea of geographical differences and time trends in the frequency of celiac disease.
    The research team included J. Y. Kang, A. H. Y. Kang, A. Green, K. A. Gwee, and K.Y. Ho. They are affiliated with the Department of Gastroenterology, St George's Hospital, London, UK, the Yong Loo Lin School of Medicine at the National University of Singapore, and with the Department of Gastroenterology and Hepatology at the National University Health System in Singapore.
    To get the data that would help them to compare geographical differences and time trends, the team conducted Medline and Embase searches covering a period from 1946 to 1980, using the key words: coeliac disease or celiac disease + prevalence, incidence or frequency.
    Their data showed significant differences between and within countries in the prevalence and incidence of celiac disease. For example, in all of reported English medical literature, there have been only 24 ethnic Chinese and Japanese patients with celiac disease.  Of celiac-associated HLA DQ antigens, DQ2 occurs in 5–10% of Chinese and sub-Saharan Africans, compared to 5–20% in Western Europe. DQ8 occurs in 5–10% of English, Tunisians and Iranians, but in less than 5% of Eastern Europeans, Americans and Asians.
    Rates and overall numbers of both clinically and serologically diagnosed celiac disease have risen in recent years. Celiac disease is increasing in frequency, with significant geographical differences.
    The team's geographical and temporal differences seem genuine, but a large number of hypothesis and lack of diagnostic facilities have made it difficult to reach any solid conclusions.
    Although few cases have been found in Asia and Sub-Saharan Africa, there is a significant prevalence of HLA DQ2 and wheat consumption is about the same as in Western Europe.
    It is possible that celiac disease may become more common in these countries in the future.
    Source:
    Aliment Pharmacol Ther. 2013;38(3):226-245.

    Jefferson Adams
    BioLineRx Clears Latest Hurdle for Celiac Treatment Drug
    Celiac.com 12/09/2014 - Biopharmaceutical company BioLineRx Ltd., has announced successful final results from its Phase 1/2 study for BL-7010, a novel co-polymer for the treatment of celiac disease.
    BL-7010 is a new, non-absorbable, orally available co-polymer intended for the treatment of celiac disease. The drug works by sequestering gliadins, effectively masking them from enzymatic degradation and preventing the formation of immunogenic peptides that trigger an adverse immune reaction when people with celiac disease consume wheat.
    This significantly reduces the immune response triggered by gluten. BL-7010 is excreted with gliadin from the digestive tract and is not absorbed into the blood.
    The trial results showed BL-7010 to be safe and well tolerated in both single- and repeated-doses, and pharmacokinetic analyses revealed no systemic exposure of BL-7010 in plasma and urine samples.
    The company has also settled on a one gram, three times per day regimen of BL-7010 as the optimal repeated dose for an upcoming randomized, placebo-controlled efficacy study set to begin in the last half of 2015.
    The absence of systemic exposure will likely support a medical-device classification for BL-7010, which would significantly accelerate its development in Europe.

    Source:
    Marketwatch.com

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