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Found 9 results

  1. Celiac.com 10/15/2012 - The drug ALV003, a potentially promising treatment celiac disease, made by Alvine Pharmaceuticals, Inc., has received Fast Track designation from the U.S. Food and Drug Administration (FDA). ALV003 is an orally administered mix of two recombinant gluten-specific proteases, a cysteine protease (EP-B2) and a prolyl endopeptidase (PEP). ALV003 works by targeting gluten and breaking it down into tiny fragments, which, in tests has been show to greatly reduce its ability to trigger immune responded in people with celiac disease. ALV003 is being developed as a potential treatment for celiac disease patients in conjunction with a gluten-free diet and is currently in phase 2 clinical development. The Fast Track status is important for ALV003, because there are currently no approved therapeutic treatment options available to patients and their physicians," said Abhay Joshi, Ph.D., Alvine's President and Chief Executive Officer. Fast Track is part of the FDA Modernization Act, passed in 1997. It is designed to streamline the development and review of drugs that treat serious or life-threatening conditions, and which address unmet medical needs. Source: Marketwatch
  2. Celiac.com 10/29/2012 - Celiac disease with epilepsy and cerebral calcifications, also known as CEC, is a rare form of celiac disease that is accompanied by occipital epilepsy. Past studies have suggested that the neurological symptoms could be the result of a folate deficiency, as folate levels are typically low in patients suffering from CEC. However, a recent case report indicates that as with other neurological gluten-related diseases (such as gluten ataxia), there may be some correlation between CEC and TG6 autoantibodies, indicating that the disease is autoimmune in nature. The case study focuses on a four year old boy who suffered from 30+ minute long complex partial seizures every two to three days. He was given antiepileptic drugs (carbamazepine, sodium valproate, levetiracetam), but these only slightly helped reduce seizure frequency. After one year, MRI and CT scans revealed bilateral occipital calcifications over parieto-occipital regions of the brain. The patient also suffered from chronic diarrhea: endoscopy and biopsy confirmed villous atrophy and patient tested positive for antibodies associated with celiac disease. His folate levels were also markedly low. After being placed on a gluten-free diet, the patient's symptoms, including seizures, cleared within two weeks. After the seizures had ceased, the patient was given folate supplements, and taken off antiepileptic drugs. Gluten challenge caused a relapse of all symptoms. At the time of the report, the patient had been gluten-free and seizure-free for 18 months, and showed improved behavior and reading and writing abilities. Because the patient responded so well to gluten-free diet treatment before being given folate supplements and all symptoms resumed during gluten challenge, it would seem that the neurological symptoms of CEC are the result of immune mechanisms rather than vitamin deficiencies or malabsorption. Most CEC patients have low folate levels; folate deficiency was previously thought to play a causative role in the disease, but this case study brings that conclusion into question. Furthermore, the patient tested positive for TG6 autoantibodies, which are associated with gluten ataxia (another gluten-related disease with neurological symptoms, which are an autoimmune response). More studies are required, but this case study suggests that gluten ataxia is not the only gluten-related disease with autoimmune neurological manifestations. Source: http://www.ncbi.nlm.nih.gov/pubmed/22845673
  3. Gastroenterology 2005;129:797-806,1111-1113. Celiac.com 10/28/2005 – According to Dutch researchers, it may be possible to produce varieties of wheat that are safe for people with celiac disease. Dr. Spaenij-Dekking of Leiden University Medical Center and colleagues examined public databases that contained data on the many different varieties of wheat gluten proteins which can be found in wheat. Their goal was to identify the wheat varieties that contained the lowest levels of T-cell- stimulatory epitopes. The researchers found that the level of toxicity of the different types of wheat varies greatly, and the more ancient and grass-like the variety the less T-cell- stimulatory epitopes it contained, and conversely, the more modern the variety the greater its level of toxicity for those with celiac disease. They concluded that the use of selective breeding and screening could create a variety of wheat that is safe for those with celiac disease, and one that could prevent disease in those who are at risk.
  4. Celiac.com 04/18/2011 - In an effort to improve diagnosis of celiac disease in patients already on a gluten-free diet, a team of researchers recently evaluated HLA-DQ2-gliadin tetramers for detection of gluten-specific T cells in peripheral blood and histological changes in the duodenum after a short gluten challenge as a diagnostic tool. The study team included Margit Brottveit MD, Melinda Ráki MD, PhD, Elin Bergseng MScPharm, PhD, Lars-Egil Fallang MSc, PhD, Bjørg Simonsen BLS, Astrid Løvik MSc, Stig Larsen MSc, PhD, Else Marit Løberg MD, PhD, Frode L Jahnsen MD, PhD, Ludvig M Sollid MD, PhD, and Knut EA Lundin MD, PhD. They are associated variously with the Department of Gastroenterology, the Department of Medicine, and the Department of Pathology at Oslo University Hospital in Ullevål, Norway, the Centre for Immune Regulation at the Institute of Immunology at the University of Oslo and Oslo University Hospital, the Department of Pathology at Oslo University Hospital in Rikshospitalet, Norway, and the Norwegian School of Veterinary Medicine, Oslo, Norway. For their study, the team evaluated HLA-DQ2+ individuals on a gluten-free diet for at least 4 weeks. 35 patients had uncertain diagnosis, 13 patients had celiac disease, and 2 healthy subjects served as disease controls. The team challenged each participant with four slices of gluten-containing white bread per day for 3 days (d1–d3). The team took biopsy samples via esophagogastroduodenoscopy on d0 and d4, and scored the biopsies using Marsh criteria. On d0 and d4, team isolated peripheral blood celiac disease 4+ T cells, stained them with HLA-DQ2-gliadin peptide tetramers, and analyzed the results using flow cytometry. After the gluten challenge, 11 of the 13 celiac disease patients showed a positive tetramer test, while four of them also showed typical histological changes on biopsy. Of the 35 patients with uncertain celiac diagnosis, 3 were found to have celiac disease. Two of these three patients showed both positive tetramer stains and histological changes in biopsies after gluten challenge. Overall, the team found celiac disease in about ten percent of the group with self-prescribed gluten-free diet. From these results, the team concluded that tetramer staining for gluten-specific T cells is a sensitive method in detecting an immune response in celiac disease patients after a short gluten challenge. SOURCE: Am J Gastroenterol advance online publication 1 March 2011; doi: 10.1038/ajg.2011.23
  5. Celiac disease is known to be triggered, at least in part, by environmental factors. These factors can even affect one identical twin and not the other and seem to have their greatest impact during infancy when gluten is first introduced to the diet. Gut flora makeup and vitamin D levels are 2 factors which differ in infants and could affect the development of the immune system in ways leading to celiac disease. Recent research has shown that gut Bifidobacterium levels are lower in both treated and untreated celiac disease patients. Bifidobacterium species have properties which are beneficial to the immune system such as increasing IL-10 secretion and decreasing intestinal permeability. But other microbiota species may also have important effects and benefits to the developing immune system. Scientists are only beginning to scratch the surface both in cataloging the microbiota species found in the gut and understanding how environmental factors, such as antibiotics, affect their makeup and, in turn, how the makeup of gut microbiota affects human health. A new article on Medscape.com discusses the current state of this research and is excellent reading: Gut Reaction: Environmental Effects on the Human Microbiota Melissa Lee Phillips Published on Medscape.com: 07/15/2009 http://www.medscape.com/viewarticle/705512_print It may be years before research fully understands how gut microbiota and vitamin D deficiency may be involved in triggering celiac disease. Both vitamin D and probiotic supplements (such as Bifidobacterium infantis) are cheap, readily available, and generally safe. There is much current research showing how important vitamin D is for overall health. Your infant's health is a matter of immediate concern and cannot wait 5 or 10 years for research to confirm whether such supplements can help prevent celiac disease. It would seem prudent to make use of these supplements now in both mother and infant during pregnancy, while breast-feeding, and prior to introducing gluten to your baby. Consult with your physician about how much is the right dose.
  6. J Pharmacol Exp Ther. 2004 May 13 Piper JL, Gray GM, Khosla C. Stanford University. Celiac.com 11/28/2004 - A study by researchers at Stanford University looked at the ability of Prolyl endopeptidase (PEP)--a specific type of enzyme--to break down gliadin peptides in a living organism--rats. In an effort to determine whether a resistance to the break down of proteins by proteases enzymes is the cause of toxicity of the Pro- and Gln-rich peptides, the scientists analyzed the digestive resistance of a panel of alpha and gamma-gliadin peptides that are believed to induce gluten toxicity--all of which happen to be very resistant to gastric and pancreatic protease digestion--but can be broken down by intestinal brush border peptidases. The researchers determined that supplementation of PEP substantially reduced the concentrations of these peptides, and they determined a pharmacologically useful PEP dosage. According to the researchers: "This data verifies and extends our earlier proposal that gliadin peptides, while resistant to proteolysis, can be processed efficiently by PEP supplementation. Indeed, PEP may be able to treat Celiac Sprue by reducing or eliminating such peptides from the intestine."
  7. (Celiac.com 08/13/2000) Because celiac disease has emerged as a public health problem, Swedish researchers conducted a study to analyze the trends in the occurrence of symptomatic celiac disease in Swedish children from 1973 to 1997, and to explore any temporal relationship to changes in infant dietary patterns. The researchers established a population-based prospective incidence register of celiac disease in 1991, and collected data retrospective date from 1973. A total of 2,151 cases met their diagnostic criteria, and were used in the study. In addition the researchers collected national data on an annual basis regarding the duration of breastfeeding and intake of gluten-containing cereals and recommendations on when and how to introduce gluten to the diets of infants. The incidence of celiac disease in children below 2 years of age increased fourfold (200-240 cases per 100,000 person years) between 1985 and 1987, followed in 1995 by a sharp decline to the previous level (50-60 cases per 100,000 person years). A pattern like this one is quite unique for a chronic disease of immunological pathogenesis, which suggests that prevention could be possible. This study demonstrates that the celiac disease epidemic is in part the result of a change in three factors within the area of infant feeding, including the amount of gluten given, the age of gluten introduction, and whether breastfeeding was ongoing or not when it was introduced. There may also be additional factors involved, and the search for them should be intensified. Ivarsson A, Persson LA, Nystrom L, et al Acta Paediatr. 2000 Feb;89(2):165-71
  8. 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
  9. Celiac.com 10/28/2005 - Alba Therapeutics Corporation (Alba) today announced successful completion of its first Phase I trial for the drug candidate AT-1001, and that the FDA has granted Fast Track designation to AT-1001 for treatment of celiac disease. We are pleased to have concluded our first human study of oral AT-1001 and delighted that the FDA has granted fast track status to AT-1001. These two events are important additional milestones in our efforts to help those suffering from celiac disease, a disease for which there is no effective treatment, said Blake Paterson, MD, President and CEO of Alba. Alba plans to begin a proof of concept study demonstrating efficacy of AT-1001 in celiac patients within the next few months. Fast track process is designed to facilitate development and expedite the review of new drugs with the potential to address significant unmet medical needs for the treatment of serious or life-threatening conditions. Potential fast track benefits include FDA input into development, submitting new drug applications in sections rather than all at once and the option of requesting Accelerated Approval. About Celiac Disease Celiac disease is a T-cell mediated auto-immune disease that occurs in genetically susceptible individuals and is characterized by small intestinal inflammation, injury and intolerance to gluten. Gluten is a mixture of proteins found in common food grains such as wheat, rye and barley. According to the NIH, celiac disease affects approximately 3 million Americans, although the diagnosis is rarely made. The only treatment for celiac disease is complete elimination of gluten from the diet, which results in remission for some patients. About Zonulin Zonulin is an endogenous signaling protein that transiently and reversibly opens the tight junctions (tj) between the cells of epithelial and endothelial tissues such as the intestinal mucosa, blood brain barrier and pulmonary epithelia. Discovered by Alba co-founder Dr. Alessio Fasano, zonulin appears to be involved in many disease states in which leakage occurs via paracellular transport across epithelial and endothelial tight junctions (tj), and thus may play an important potential role in the treatment of auto-immune diseases. About Alba Alba Therapeutics Corporation is a privately held biopharmaceutical company based in Baltimore, Maryland. Alba is dedicated to commercializing disease-modifying therapeutics and drug delivery adjuvants based on the zonulin pathway. Albas lead molecule, AT-1001, is targeted towards the treatment of Celiac Disease and Type 1 Diabetes. Contact: Dr. Blake Paterson Alba Therapeutics Corporation 410-522-8708
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