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Found 17 results

  1. Celiac.com 02/20/2019 - Pharmaceutical company ImmusanT is developing a celiac disease vaccine called Nexvax 2. Many vaccines provide long-term or permanent protection against disease after just one, or several doses. Because celiac disease is not caused by a virus, like polio, but is a response to the presence of an antigen (similar to an allergen that triggers an allergy), the approach to creating a vaccine like Nexvax 2 is different and, in some ways, easier, than creating a traditional vaccine, like the HPV vaccine. Nexvax 2 is a vaccine in much the same way that allergy shots are, but not in the way the polio vaccine is. Celiac Vaccine is Similar to Allergy Shots Unlike traditional vaccines, such as the polio vaccine, or the measles vaccine, Nexvax 2 does not inject a small dose of dead or weakened virus, or any virus fragment, into the patient to achieve disease immunity. Allergy shots work by desensitizing the body’s reaction by strengthening the immune system, thereby reducing or eliminating reactions to certain allergens. Nexvax 2 would work in a similar manner to allergy shots. It would build tolerance levels until there was little or no immune reaction to gluten exposure. Anyone who’s ever had allergy shots knows that their effectiveness can range from person to person. Some people get minimal relief, though most see good to excellent results. Many experience tremendous relief, and see their symptoms disappear. Nexvax 2 Faces Easier Path to Approval Because Nexvax 2 works less like a traditional vaccine, and more like allergy therapy, the process for testing and approval is potentially easier and shorter; several years, rather than a decade or more. The hope is that, once treated with Nexvax 2, “the immune system, now seeing these fragments of gluten in a different way, might learn to tolerate gluten," said Benjamin Lebwohl, director of clinical research at the Celiac Disease Center at Columbia University. Certainly, the ability to reduce or neutralize the body’s reaction to gluten in people with celiac disease would be a major breakthrough in the treatment of celiac disease. Benefits for celiac patients could include a reduction in severity of gluten contamination symptoms, and potentially an elimination of symptoms entirely. Nexvax 2 treatment, if successful, could allow some people with celiac disease to safely consume wheat. That is potentially huge news. Phase two clinical trials of the Nexvax 2 are slated for completion by the end of 2019. Read more: Promising Celiac Vaccine Nexvax 2 Begins Phase Two Trials
  2. Celiac.com 04/03/2017 - Massachusetts biotech firm ImmusanT has announced the successful completion of its first phase 1b trial of Nexvax2, an immunotherapy drug designed to protect celiac sufferers from the adverse effects of gluten exposure, including gastrointestinal symptoms, such as diarrhea, abdominal pain and bloating. Nexvax2 is a drug that relies on three peptides designed to promote T cells involved in the inflammatory reaction in celiac disease to become tolerant to gluten. The company hopes that an initial course will promote gluten-tolerance, which can then be maintained by periodic boosters of the vaccine. The phase 1b trial in 38 patients showed no issues with safety or tolerability, and indicated that the immunotherapy seemed to work as designed. The study also helped ImmusanT to determine dosages for phase 2 trials to determine if Nexvax2 can protect patients on a gluten-free diet from inadvertent gluten exposure, which ImmusanT sees as the quickest route to approval. If Nexvax2 proves to be effective in preventing accidental gluten exposure in celiac patients, the company plans a follow-up program to see if immunotherapy with Nexvax2 can eliminate the need for a gluten-free diet in celiac patients; a step that represents a daunting challenge, and is somewhat of a Holy Grail for celiac researchers. ImmusanT is also developing diagnostic protocols for the vaccine, which are designed to guide its use and help improve diagnosis rates. Nexvax2 is just the latest in a large crop of auxiliary treatments aimed at celiac disease. Switzerland's Anokion teamed up with Japanese pharma Astellas in 2015 to form Kanyos, a company working on an immunotherapy for celiac disease along with type 1 diabetes. A company called Sanofi is also working with Selecta on a similar approach. Meanwhile, in 2013 AbbVie licensed rights to Alvine Pharmaceuticals AVL003, an oral therapy designed to break down gluten in the GI tract before it can cause damage. So, stay tuned celiac sufferers, the next few years could produce some very interesting new treatments for celiac disease, something considered impossible just ten years ago. Source: Fierce Biotech
  3. Celiac.com 11/10/2016 - Seronegative villous atrophy (SNVA) is commonly attributed to celiac disease. However, celiac is not the sole cause of SNVA. Recent reports have pointed to a connection with angiotensin-2-receptor-blockers (A2RBs), but data on such cases of SNVA was limited to centers dealing with complex case referrals, and not SNVA in general. A team of researchers recently completed a clinical and phenotypical assessment of SNVA over a 15-year period. The research team included I Aziz, MF Peerally, JH Barnes, V Kandasamy, JC Whiteley, D Partridge, P Vergani, SS Cross, PH Green, DS Sanders. They are variously affiliated with the Academic Department of Gastroenterology, the Department of Microbiology, the Department of Histopathology at the Royal Hallamshire Hospital in Sheffield, UK, and with the Department of Medicine, Columbia University College of Physicians and Surgeons, Celiac Disease Center, New York, New York, USA. Over a 15-year period (2000-2015) the team assessed 200 adult patients with SNVA. Patients were diagnosed with either seronegative celiac disease (SNCD) or seronegative non-celiac disease (SN-non-celiac disease). The team then made baseline comparisons between the groups, with 343 seropositive celiac disease patients serving as controls. Of the 200 SNVA cases, SNCD represented 31% (n=62) and SN-non-celiac disease 69% (n=138). The human leucocyte antigen (HLA)-DQ2 and/or DQ8 genotype was present in 61%, with a 51% positive predictive value for SNCD. The breakdown of identifiable causes in the SN-non-celiac disease group comprised infections (27%), inflammatory/immune-mediated disorders (17.5%) and drugs (6.5%; two cases related to A2RBs). However, the researchers found no obvious cause in 18%, while duodenal histology spontaneously normalized in 72% of SNVA patients, while those patients were consuming a gluten-enriched diet. Following multivariable logistic regression analysis, the only independent factor associated with SN-non-celiac disease was non-white ethnicity (OR 10.8, 95% CI 2.2 to 52.8); in fact, 66% of non-white patients showed GI infections. On immuno-histochemistry all groups stained positive for CD8-T-cytotoxic intraepithelial lymphocytes. However, additional CD4-T helper intraepithelial lymphocytes were occasionally seen in SN-non-celiac disease mimicking the changes associated with refractory celiac disease. Most patients with SNVA, especially non-white patients, do not have celiac disease. Furthermore, a subgroup of patients with no obvious cause for their SNVA will show spontaneous histological resolution while consuming gluten. Based on these findings, the researchers encourage doctors to investigate patient condition before prescribing a gluten-free diet. Source: Gut. 2016 Sep 7. pii: gutjnl-2016-312271. doi: 10.1136/gutjnl-2016-312271.
  4. Celiac.com 04/04/2016 - Any one eager to try the first approved treatment for celiac disease might not have to wait much longer. Alba Therapeutics has announced that their celiac treatment, larazotide acetate, will enter the first Phase 3 clinical trials ever conducted in a celiac disease drug later this year. Lorazotide acetate works by improving regulation of tight junctions in the bowel. In healthy people, these junctions remain closed except to shed dead cells, but in patients with celiac disease, gluten keeps tight junctions open, triggering an inflammatory reaction that eventually destroys the intestinal villi, tiny, finger-like projections in the small intestine that are essential for nutrient absorption. Early research suggests larazotide acetate helps to keep the tight junctions closed when it's taken before a meal, thus stopping, or reducing the reaction and the resulting inflammation. Larazotide acetate recently completed during phase 2b clinical trials for efficacy, safety and tolerability in 342 patients with celiac disease. Those trials showed larazotide acetate to be safe and effective in a "real world setting" for celiac patients, according to Alba's website. The treatment is now headed to Phase 3 trials in "late 2016", and has received "fast track" designation from the Food and Drug Administration. Alba has announced that Innovate Biopharmaceuticals Inc. has licensed all of Alba Therapeutics' assets related to larazotide acetate, and that larazotide acetate has been renamed INN-202. If approved on schedule, INN-202 will become the first prescription medicine for treating celiac disease. Source: Allergic Living
  5. Celiac.com 06/15/2016 - Every so often, a medical case comes along that puzzles or interests clinicians. One recent case of celiac disease fits that bill. The patient in this case is a 61-year-old obese woman who developed severe diarrhea that started soon after bariatric surgery and did not respond to standard medical treatment. The team treating the woman reports that, to their knowledge, this is the first reported case of clinical onset of celiac disease (celiac disease) following duodenal switch surgery. The research team included A Pané, A Orois, M Careaga, A Saco, E Ortega, J Vidal, P Leyes, and AJ Amor. They are variously affiliated with the Department of Endocrinology and Nutrition, and the Department of Anatomic Pathology at the Hospital Clínic in Barcelona, Spain. After the team ruled out the most common post-operative causes of diarrhea, they ran some blood tests, and made a final diagnosis based on positive results for anti-tissue transglutaminase antibody. In light of this case report, the team proposes that celiac disease should be ruled out in any patient presenting with typical or atypical symptoms after bariatric surgery, regardless of the latency of onset. Read more on this case in the Eur J Clin Nutr. 2016 Apr 20. doi: 10.1038/ejcn.2016.65.
  6. Celiac.com 04/20/2015 - Microscopic enteritis is an inflammatory condition of the small bowel that leads to gastrointestinal symptoms, nutrient and micronutrient deficiency. The idea of microscopic enteritis arose from mucosal changes associated with celiac disease and was originally described in detail by Marsh in 1992. Microscopic enteritis is marked by microscopic or sub-microscopic abnormalities such as microvillus changes and enterocytic alterations in the absence of definite macroscopic changes using standard modern endoscopy. A recent study addresses the need to characterize disorders with microscopic and submicroscopic features, currently regarded as functional or non-specific entities, to obtain further understanding of their clinical relevance. Following the 5th International Course in Digestive Pathology in Bucharest in November 2012, an international group of 21 interested pathologists and gastroenterologists formed a working party with a view to formulating a consensus statement on Microscopic enteritis. The research team included Kamran Rostami, David Aldulaimi, Geoffrey Holmes, Matt W. Johnson, Marie Robert, Amitabh Srivastava, Jean-François Fléjou, David S. Sanders, Umberto Volta, Mohammad H. Derakhshan, James J Going, Gabriel Becheanu, Carlo Catassi, Mihai Danciu, Luke Materacki, Kamran Ghafarzadegan, Sauid Ishaq, Mohammad Rostami-Nejad, A. Salvador Peña, Gabrio Bassotti, Michael N. Marsh, and Vincenzo Villanacci. The team reviewed statements about the etiology, diagnosis and symptoms associated with microscopic enteritis and proposes an algorithm for its investigation and treatment. They employed a five-step agreement scale (ranging from strong agreement to strong disagreement) to score 21 statements, independently. They found strong agreement on all statements about Microscopic enteritis histology (95%-100%). They found 85% to 100% agreement regarding statements concerning diagnosis, while agreement on a statement about the management of microscopic enteritis ranged from the 60% to 100%. They also found general agreement between experts on clinical presentation (75%-95%) and pathogenesis (80%-90%) of Microscopic enteritis. Lastly, they found strong agreement on the histological definition of Microscopic enteritis. The weaker agreement on management invites further studies, better definitions and clinical trials to produce quality guidelines for management. This microscopic enteritis consensus is a step toward greater recognition of a significant issue for symptomatic patients previously labelled as non-specific or functional enteropathy. Source: World J Gastroenterol. 2015 Mar 7; 21(9): 2593–2604. doi: 10.3748/wjg.v21.i9.2593. PMCID: PMC4351208
  7. Celiac.com 09/10/2012 - Last year, ImmusanT's Nexvax2 celiac disease vaccine passed its phase 1 clinical trials in Australia and New Zealand, causing a stir of hope and anticipation within the celiac disease community. It will still be a while before the vaccine is available to the public, but yesterday ImmusanT announced that it commenced phase 1b clinical trials in New Zealand and Australia and phase 1 clinical trials in the U.S. New Zealand and Australia's phase 1b randomized, placebo-controlled, double-blind study will follow on the prior phase 1 trials and involve approximately 84 celiac disease patients on gluten-free diet at four study sites throughout the two countries. The focus of the study will be on evaluating safety, tolerability and pharmacokinetics (what the body does to the drug), as well as determining appropriate doses for subsequent studies. In the U.S., the phase 1 randomized, placebo-controlled, double-blind study will involve 30 celiac disease patients on gluten-free diet at approximately four test sites throughout the country. This preliminary study will evaluate safety, tolerability, and pharmacokinetics of the drug for American subjects. Patients in both studies will have confirmed diagnosis of celiac disease, as well as the HLA-DQ2 gene (which approximately 90% of celiac disease sufferers carry). Blood tests for gluten-reactive T cells will also be used to select suitable test subjects. The studies will employ an intradermal injection vaccine delivery solution by BD. The Nexvax2 vaccine is intended to restore the body's ability to tolerate gluten. It is hoped that antigen-specific T cells will be the key to allowing patients to consume gluten freely with no adverse effects. If all goes well during this and subsequent clinical trials, we could have a cure for celiac disease in the not-too-distant future. Source: http://www.sacbee.com/2012/09/04/4784050/immusant-initiates-clinical-trials.html
  8. Celiac.com 11/30/2011 - Researchers have been talking about it for some time, raising the hopes of the celiac community: a drug to help relieve us from the harmful effects of gluten exposure. Celiac patients are closer than ever to having such a drug on the market, as Alvine Pharmaceuticals has announced that their drug ALV003 has shown promise in a clinical trial by reducing gluten-triggered harm in people with celiac disease. Celiac disease is an autoimmune reaction triggered by exposure to gluten, a protein found in wheat, barley, and rye, that causes the immune system to attack the small intestine, interfering with the absorption of nutrients and leading to malnutrition and a variety of other symptoms. The disease currently has only one treatment, which is non-drug: the gluten-free diet. By eliminating gluten completely from the diet, most celiac patients can heal their small intestine. There is currently no other drug on the market that can help relieve the symptoms of celiac disease or the intestinal damage it can cause. Now Alvine Pharmaceuticals, which is focused on developing biopharmaceuticals for autoimmune inflammatory diseases such as celiac disease, has reported favorable results for a trial with their drug ALV003, which was developed to lessen mucosal injury in the intestine caused by gluten exposure in well-controlled celiac patients. A control group study was conducted that collected data from 34 celiac patients. After both the active drug group and placebo group ingested two grams of gluten on a daily basis for six weeks, "The group with the placebo reported higher incidence of 'non-serious adverse events' (code for GI symptoms)," Triumph Dining reported. "They also had significantly more mucosal injury in their small intestines, as measured by biopsy data." ALV003 works by breaking down the gluten molecule into nontoxic parts. (Alvine Pharmaceuticals explains more specifically how the drug works on their website, AlvinePharma.com.) The drug is intended to help alleviate the gastrointestinal and other symptoms associated with cross-contamination, incorrect or misleading "gluten-free" labeling, and exposure to gluten caused by carelessness or imprudence. Even when celiac patients take care to maintain a strict gluten-free, it's difficult to stay completely away from gluten. That's why, according to coordinating investigator of the latest ALV003, Markku Maeki, M.D., chair and professor of pediatrics at the University of Tampere and Tampere University Hospital in Finland, "New non-dietary treatment options that can either eliminate, or meaningfully reduce the gluten present in an attempted gluten-free diet are needed." Currently celiacs have no drug options to help alleviate their symptoms. "These results are groundbreaking," said Professor Maeki, "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." According to Triumph Dining, "After Phase 3 trials, so long as results remain promising, ALV003 will enter Phase 2b trials soon; after that come Phase 3 trials and (hopefully) submission to the FDA for approval." The release of ALV003, should results remain favorable, will no doubt bring relief to many members of the celiac community.
  9. Celiac.com 05/23/2011 - ImmusanT, Inc., a biotechnology start up based in Cambridge, Massachusetts, is testing a vaccine to desensitize celiac patients to gluten. It is called Nexvax2, and it has already passed Phase I clinical trials, which means that it is safe and tolerable to humans. Nexvax2 is slated to begin Phase II trials, which address efficacy, within the next year. Nexvax2 was developed by Nexpep Pty, Ltd., a company in Melbourne, Australia. It is based on their findings that only three peptides are responsible for eliciting the majority of the T cell response that goes on to destroy the intestines of celiac patients. HLA molecules function to present these toxic peptides to T cells; this presentation is what activates the T cells, instigating the inflammatory response. Thus, this vaccine relies on the HLA type. It is specific for celiacs with the HLA-DQ2 haplotype, accounting for about 90% of celiac patients. Nexvax2 encompasses these three proprietary peptides, presenting them to T cells in the absence of a second, T-cell stimulatory signal. T cell recognition of the HLA-DQ2 bound toxic peptides thus occurs in a non-inflammatory environment, establishing tolerance to dietary gluten. This peptide based approach has been successful in generating tolerance in people with cat-sensitive asthma, and has not been used more broadly because it has been difficult to identify the correct toxic epitopes. Similar efforts are underway to discover and develop peptide-based therapeutic vaccines for other autoimmune diseases, including multiple sclerosis, Type-1 diabetes, and rheumatoid arthritis, but celiac disease is an ideal target for the technology because the HLA types that activate the inflammatory T cells in celiac disease are so well defined. The vaccine consists of a weekly or monthly injection, and would allow those with celiac disease to resume eating "normal" levels of gluten without suffering adverse effects. Other therapies that have proposed to treat celiac disease, such as those promoted by the companies Alva, Alba, and Chemocentryx, did not aim to replace the gluten free diet; they allowed only small, intermittent exposure to gluten. During the Phase I trial of Nexvax2, some people who got the injections containing the highest doses of the toxic peptides suffered gastrointestinal distress; they thus inadvertently acted as a positive control, indicating that the peptides administered are in fact the correct ones. ImmusanT is also partnering with INOVA Diagnostics to use reactivity to these peptides as a diagnostic test both for celiac disease and for those celiac patients who might be good candidates for the Nexvax2 vaccine - i.e. those 90% who are HLA-DQ2 rather than those who are HLA-DQ8. Source: http://www.sciencedaily.com/releases/2011/05/110509091559.htm
  10. Celiac.com 12/07/2009 - Collagenous sprue is associated with high morbidity, but the etiology of this condition is poorly understood. There is little data concerning the pathological and clinical manifestations of patients with collagenous sprue. The research team set out shed some light on the etiology, disease manifestations and outcomes of collagenous sprue. A team of researchers recently undertook a clinico-pathological study of 19 patients with collagenous sprue and found that the condition does not always end badly for the patient. The research team was made up of Efsevia Vakiani, Carolina Arguelles-Grande, Mahesh M Mansukhani, Suzanne K Lewis, Heidrun Rotterdam, Peter H Green and Govind Bhagat. They are associated with either the Department of Pathology at New York's Memorial Sloan-Kettering Cancer Center, or with Columbia University's Department of Medicine or of Pathology. The team searched their departmental database covering the periods from 1999–2008 to identify cases of collagenous sprue and to gather clinical and lab data. The team evaluated small bowel histology, including thickness of sub-epithelial collagen, intra-epithelial lymphocyte phenotype and results of T-cell clonality assays. The found nineteen patients (15 women, 4 men, age 22–80 years, mean 57 years). Seventeen (89%) suffered from celiac disease and two from unclassified sprue. 9 of 17 (53%) celiac disease patients had refractory disease; 5 of 15 (33%) presented atypically without diarrhea, including 2 of 6 (33%) with active (untreated) celiac disease, and 3 of 9 (33%) with refractory celiac disease. They found autoimmune disorders in 12 of 19 (63%) patients and microscopic colitis (n¼7), lymphocytic gastritis (n¼2) or collagenous gastritis (n¼2) in nine patients. Thickness of subepithelial collagen increase varied from mild (n¼6), moderate (n¼10), or marked (n¼3), and villous atrophy from total (n¼13) to subtotal (n¼6). In no case did they find phenotypically aberrant intraepithelial lymphocytes. The only patient with refractory celiac disease type II showed a dominant T-cell clone with polymerase chain reaction analysis. 7 of 11 (64%) patients showed histological improvement. Overall, 8 of 19 (42%) responded favorably to a gluten-free diet, including 2 of 9 (22%) with refractory celiac disease. 10 of the 19 patients responded to immuno-modulatory therapy, including 6 of 9 (67%) with refractory celiac disease. Only one patient died from the effects of refractory celiac disease. No patient developed lymphoma. The vast majority of patients with collagenous sprue did have celiac disease. Even though numerous patients required immuno-modulatory therapy to control symptoms, many responded to gluten-free diet alone. The researchers conclude that most collagenous sprue patients have relatively good clinical outcomes. Source: Modern Pathology 23 October 2009; doi:10.1038/modpathol.2009.151
  11. Celiac.com 03/03/2010 - A team of researchers set out to assess long-term outcomes of thyroid function and autoimmunity in a large population of children with celiac disease. The research team included Alessandra Cassio, MD, Giampaolo Ricci, MD, Federico Baronio, MD, Angela Miniaci, MD, Milva Bal, MD, Barbara Bigucci, MD, Veronica Conti, MD, and Alessandro Cicognani, MD. To accomplish this, they conducted a longitudinal, retrospective study at the Pediatric Department, University of Bologna, Italy (duration of follow-up, 8.9 +- 4.0 years). In all, the team examined one hundred thirty-five consecutive patients diagnosed between June 1990 and December 2004 and followed on a gluten-free diet. To be included, researchers required study subjects to maintain good dietary compliance and duration of follow-up for at least 3 years. A total of 101 patients showed no positive antithyroid titers during the follow-up, while 86 remained euthyroid; 15 showed high thyroid-stimulating hormone values at diagnosis that normalized in 11 cases after 12 to 18 months of gluten withdrawal. A total of 31 patients showed persistently positive antibody titers, with 23 of those (74%) remained consistently euthyroid during the follow-up and 8 (26%) had a subclinical hypothyroidism. Children with growth retardation or gastroenterological symptoms at diagnosis and different lengths of gluten exposure showed similar rates of positive antibodies. In children with celiac disease, antithyroid antibodies have a low clinical value for predicting the development of thyroid hypo-function during the indicated surveillance period. They encourage a more comprehensive follow-up. Source: J Pediatr. Volume 156, Issue 2, Page A2; February 2010
  12. Celiac.com 05/08/2007 - Announces Plans for Advancing AT-1001 into Later Stage Clinical Trials Alba Therapeutics Corporation today announced preliminary results from its Phase IIa clinical trial for AT-1001 in subjects with Celiac Disease (celiac disease), an autoimmune disease affecting over 3 million people in the United States. Albas study, the first Phase IIa trial in celiac disease and the first to assess dosing requirements for AT-1001 in celiac disease, was designed to evaluate the safety, tolerability and efficacy of multiple doses of AT-1001 in celiac disease subjects during a 2-week gluten challenge. The randomized, double-blind, placebo-controlled clinical trial enrolled 86 patients who were confirmed biopsy positive for celiac disease and in compliance with a gluten-free diet for at least six months prior to enrollment. Patients were randomized into seven drug-treated and placebo groups and challenged three times a day with gluten during a 14-day period. Four doses of the enteric coated oral formulation of AT-1001, all less than 10 mg, were given prior to each gluten challenge. Study endpoints included intestinal permeability (IP) -- a marker of disease state in celiac disease -- as well as patient symptoms and outcomes, measured by two validated tests of gastrointestinal disease outcome: the Gastrointestinal Symptoms Rating Scale (GSRS) and the Psychological General Well-Being Index (PGWBI). Preliminary analysis revealed the following: -- At day 14, IP, as measured by the change in urinary lactulose-to- mannitol (LA/MA) ratio, exhibited a dose dependent response. On day 21, one week after the final drug dosing and gluten challenge, the dose dependent trend continued to statistically significant levels. -- The GSRS and PGWBI provided additional efficacy signals that further support the IP observations. Patients on the AT-1001 drug arms performed better than those on the gluten/placebo arm. Analyses demonstrated that several symptoms and outcomes improved at statistically significant levels. -- Safety and tolerability of multiple oral doses of AT-1001 in the patient population was demonstrated. There were no Severe Adverse Events and all Adverse Events were reported as mild or moderate. "We are very encouraged by the preliminary data and look forward to applying the extensive knowledge gained in this Phase IIa exploratory clinical trial to a larger, highly powered Phase IIb gluten challenge study later this year" said Blake Paterson, M.D., Chief Executive Officer of Alba Therapeutics. Using the highly complex and ambitious seven arm study design for the Phase IIa trial, we repeated the proof of concept from the Phase Ib study, showed a statistically significant effect across a variety of measures and are well prepared to move the celiac program forward." Based on these results, Alba will advance AT-1001 into a Phase IIb clinical study in celiac disease subjects during the third quarter of 2007. The Phase IIb study, to be performed in multiple centers in the United States and Canada, will assess the efficacy of AT-1001 utilizing multiple endpoints, including a composite index of disease activity. The first patient is expected to be enrolled into this study in the third quarter of 2007, and the study should conclude in early 2008. About Celiac Disease Celiac Disease is a T-cell mediated autoimmune disease that occurs in genetically susceptible individuals and is characterized by small intestinal inflammation, injury and intolerance to gluten. According to the National Institutes of Health, celiac disease affects approximately 3 million Americans. The only current treatment for celiac disease is complete elimination of gluten from the diet, which results in remission for some patients. About Alba Alba Therapeutics Corporation is a privately held biopharmaceutical company based in Baltimore, Maryland dedicated to the development and commercialization of disease modifying therapeutics to treat autoimmune and inflammatory diseases based upon the regulation of tight junctions. Albas lead compound, AT-1001, is targeted towards the treatment of Celiac Disease, Inflammatory Bowel Disease and Type 1 Diabetes Contact: Stuart Sedlack, SVP, Corporate Development Phone: +1-410-319-0780
  13. Celiac.com 12/27/2005 - The BioBalance Corp. (BioBalance), a wholly owned subsidiary of New York Health Care (OTC BB: BBAL), announced today that it has received approval to begin a small-scale clinical trial of its proprietary biotherapeutic agent, Probactrix, in the dietary management of patients with celiac disease, a chronic disorder of the gastrointestinal (GI) tract. The Company also announced that it has responded to the U.S. Food and Drug Administration (FDA) regarding questions received earlier this year on the Companys Investigational New Drug (IND) application for Probactrix as a prescription drug for pouchitis, a frequent complication following bowel surgery. The pilot study for celiac will take place at Rambam Medical Center in Haifa, Israel. Dr. Rami Eliakim, the Centers Director of Gastroenterology, is the principal investigator. The study will be conducted in approximately 38 celiac patients to demonstrate the ability of a medical food formulation of Probactrix to modify the bacterial flora in the GI tract and improve quality of life. Probactrix has been proven to displace pathogenic bacteria in the GI tract and prevent their re-colonization, restoring and maintaining a healthy balance of intestinal flora without the potential negative consequences of antibiotic use. We are very excited to have approval to initiate this celiac study and to have provided a comprehensive response to FDA questions on our pouchitis IND, said Dennis ODonnell, BioBalances President and CEO. Celiac disease is an inherited condition where gluten proteins found in grains trigger an immune system attack on the lining of the small intestine. While celiac disease is rarely life threatening, it is a life altering disorder with symptoms such as diarrhea, fatigue, nausea and weight loss. Celiac is also linked to other autoimmune disorders and is now believed to lead to osteoporosis, anemia, infertility and cancer if left untreated. Diagnosis is often difficult because of the range of GI symptoms. A 2001 survey found that celiac patients in the U.S. suffer for 11 years on average before they are successfully diagnosed. Estimates from the NIH indicate that as many as one in 100 Americans have celiac disease, with significantly higher levels found in Finland, Italy, Ireland and Israel. Dr. Robert Hoerr, BioBalances Vice President of Medical & Regulatory Affairs, commented, Recent studies have identified a potential link between the overgrowth of pathogenic bacteria in the gastrointestinal tract and the symptoms of celiac disease. We are pleased to participate in this study, which will test the use of Probactrix as a means of modifying the bacterial flora in the GI tract and its impact on quality of life for these individuals. Contacts: Dennis ODonnell CEO The BioBalance Corp Tel: (212) 679-7778 Fax: (212) 679-7774 Stanley Wunderlich CEO Consulting For Strategic Growth Tel: (800) 625-2236 Fax: (212)337-8089
  14. Celiac.com 09/01/2002 - Patients with celiac disease are 20 times more likely than the general population to have epilepsy and often have associated cerebral and cerebellar calcifications imaged by CT and MRI. Depression, dementia, and schizophrenia are all also common in persons with untreated celiac disease. Cerebellar degeneration with resulting ataxia (gluten-associated ataxia) is a known entity in Europe, and the National Institutes of Health (NIH) is currently recruiting subjects with ataxia to examine them for gluten sensitivity and celiac disease. Focal white matter lesions in the brain recently have been reported to occur in children with celiac disease and are thought to be either ischemic in origin as a result of vasculitis or caused by inflammatory demyelination. Parents of children with celiac disease have reported behavioral changes such as irritability, separation anxiety, emotional withdrawal, and autistic-like behaviors that all seemed to improve on a GFD. Although not scientifically validated, the GFD is now also being advocated for children with autism by several groups. Whether or not children with autism are at a higher risk for celiac disease or celiac children have a higher incidence of autism remains to be proven. However, children with Down syndrome, who often have autistic-like behaviors, are at higher risk for celiac disease. It has been hypothesized that gluten may be broken down into small peptides that may cross the blood-brain barrier and interact with morphine receptors, leading to alterations in conduct and perceptions of reality. The serologic tests can be divided into 4 different types of antibodies: antigliadin (AGA), antireticulin, antiendomysium (AEA), and antitissue transglutaminase (tTG). Each antibody varies widely in its sensitivity, specificity, and positive and negative predictive values (Table 2). Table 2 (from Pietzak et al, 2001, compiled data from multiple studies) Test Sensitivity Specificity PPV NPD AGA IgG 57-100 42-98 20-95 41-88 AGA IgA 53-100 65-100 28-100 65-100 AEA IgA* 75-98 96-100 98-100 80-95 Guinea pig tTG† 90.2 95 Human tTG† 98.5 98 * Patients older than 2 years of age. † IgG +IgA antibodies. The AEA IgA immunofluorecent antibody is an excellent screening test for celiac disease, with both a high sensitivity and specificity. This antibody was discovered in the early 1980s and rapidly gained use as part of a screening celiac panel by commercial laboratories in combination with AGA IgG and AGA IgA. Its major drawbacks are that it may be falsely negative in children under the age of 2 years, in patients with IgA deficiency, and in the hands of an inexperienced laboratory. Also, the substrate for this antibody was initially monkey esophagus, making it expensive and unsuitable for screening large numbers of people. Recently, the human umbilical cord has been used as an alternative to monkey esophagus. However, the subjective nature of the AEA assay may lead to false-negative values and unacceptable variability between laboratories. Because tTG had been first described as the autoantigen of celiac disease in 1997, it has been used to develop innovative diagnostic tools. The tTG IgA ELISA test is highly sensitive and specific, using either the commercially available guinea pig tTG or human recombinant tTG. The tTG assay correlates well with AEA-IgA and biopsy. However, it represents an improvement over the AEA assay because it is inexpensive and rapid (30 minutes), is not a subjective test, and can be performed on a single drop of blood using a dot-blot technique. Therefore, this test is ideally suited for mass screenings and in the future could be performed in the general practitioners office, much like the now routine finger-stick hematocrit. For the reasons outlined above, the IgA class human anti-tTg antibody, coupled with the determination of total serum IgA, currently seems to be the most cost-effective way to screen for celiac disease. AEA should be used as a confirmatory, pre-biopsy test, whereas AGA determinations should be restricted to the diagnostic work-up of younger children and patients with IgA deficiency, using the guidelines in Table 3. Table 3 Probability of celiac disease based on three antibodies in combination AEA IgA AGA IgA AGA IgG Interpretation + + + Celiac disease 99% probable + - + probable + + - Celiac disease probable + - - Celiac disease probable - + + Celiac disease less likely* - - + Celiac disease less likely* - + - Celiac disease less likely - - - Celiac disease very unlikely+ * If patient is IgA sufficient: AGA IgG > 100 warrants work-up of enteropathy. + If patient is on a gluten-containing diet. Celiac disease: AEA, antiendomysium antibodies: AGA, antigliadin antibodies.
  15. TI- Klinika nietolerancji biaLek mleka krowiego i glutenu u dzieci. AU- Kaczmarski M JN- Pol Tyg Lek; 44 (4) p86-8 PY- Jan 23 1989 AB- In two comparative groups of 50 children with cow milk proteins and 45 children with gluten intolerance retrospective analysis of initial symptoms was carried out. The initial symptoms of intolerance included: vomiting, loss of appetite, recurrent diarrhea, and weight gain disorders. These symptoms closely correlated with the type of nutrition (mixed, artificial) and the duration of exposition to harmful component of the food. The symptoms appeared within first days after birth with peak intensity in 6-8 weeks of life in the group with cow milk proteins intolerance. The symptoms of intolerance were most frequent in children of group II in 7-12 months of life. To prevent food intolerance in Polish children, it is recommended to feed them naturally as long as possible and to introduce flour and 4 basic grains late (after the 6th months of life).
  16. TI- Proba prowokacyjna u dzieci z nietolerancja biaLek mleka krowiego i glutenu: ocena reakcji klinicznych i zmian w bLonie sluzowej jelita cienkiego. AU- Kaczmarski M CS- Kliniki Chorob Zakaznych Dzieci AM w BiaLymstoku. JN- Pol Tyg Lek; 45 (8-9) p161-5 PY- Feb 19-26 1990 AB- Provocation test (re-introduction of the noxious protein) was carried out in two groups of patients: (a) with intolerance to the cow-milk proteins (41 children) treated with milk-free diet for 6-24 months, and ( with gluten intolerance (26 children) treated with gluten-free diet for 6-36 months. The following parameters were compared: type and frequency of the clinical symptoms seen in these patients prior to the introduction of allergen-free diet. Moreover, the type of observed morphological changes in the small intestine mucosa following provocation test were analyzed in the groups of 7 patients. A two-year elimination of milk from the diet produces milk tolerance in about 61% patients; clinical symptoms in the remaining children are diversified. Re-introduction of gluten with the diet (provocation test) produces recurrence of gluten intolerance in 96% of children treated with gluten-free diet for 2-3 years. Recurrence of the disease was accompanied by the atrophy of the intestinal villi.
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