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Found 5 results

  1. Celiac.com 06/23/2017 - Dr. Alessio Fasano from the University of Maryland's Celiac Research Center published a paper in Clinical and Developmental Immunology last month. It focused on a new drug developed by Dr. Fasano that has shown promising results in both animal and human trials. But is this the 'magic pill' that will cure celiac disease and gluten sensitivity? Let's take a look. The new drug, formerly called AT1001 but now renamed Larazotide Acetate, is a zonulin inhibitor. For those who have never heard the word 'zonulin', you might think it's a term from a science fiction movie. But zonulin is the protein that causes the 'gates' or openings between the cells making up the lining of the small intestine to open and close. These openings are called tight junctions and when zonulin gets excessive, a leaky gut ensues. Dr. Fasano has made great inroads to prove that a leaky gut is a problem that must be handled with gluten intolerance. The leaky gut perpetuates gluten's negative impact on other parts of the body. It can also initiate autoimmune disease. One key point to keep in mind is that 'leaky gut' occurs because molecules can pass between cells when they shouldn't. In addition, molecules can pass through cells which they also shouldn't. Unfortunately this new drug only impacts the former, not the latter. So, the drug Larazotide Acetate is a zonulin inhibitor. Now that we've reviewed what zonulin does as regards opening the gates, the purpose of inhibiting its action should make sense. How well does it work? In the recent human trials that were double-blind, randomized placebo-controlled (the best type of study, but I would expect no less from the stellar Dr. Fasano), a gluten exposure created a 70% increase in intestinal permeability (leaky gut) in 57% of the placebo group but only 28.6% of the patients receiving the drug (4 out of 14 patients) experienced such increased permeability. Further, gastrointestinal symptoms were significantly more frequent among patients of the placebo group as compared to the group that received the Larazotide. A pro-inflammatory substance known as interferon gamma was also evaluated. This is manufactured by the body when a specific foreign/toxic agent is recognized by the body's immune system. As expected, levels of interferon gamma increased in 4 out of 7 of the placebo patients (57%) but only 4 out of 14 larazotide patients (28.6%) saw any increase. The good news is that this drug seems well tolerated and it does reduce the leaky gut response that gluten ingestion normally creates. Further, it also reduces the percentage, by about half, of the production of interferon gamma. These are all excellent results. But, and it's unfortunately a very big 'but', we have a very long way to go before such a drug would be useful for your typical celiac or gluten sensitive patient. Will Dr. Fasano and his team be able to tweak this drug such that it functions at a higher level of efficacy? I certainly hope so, but let's analyze exactly what this drug does in its present state: The drug still resulted in almost 30% of the patients experiencing a 70% increase in permeability (leaky gut) – Not good. A highly pro-inflammatory (this means that it creates degenerative disease) substance known as interferon gamma was also produced in nearly 30% of the drug-consuming patients tested – Not good. Leakiness, or the passage of negative substances through cells is not affected by this drug – Not good. Of course on the plus side, over 70% of those tested DID have a very good result with apparently no untoward side effects – Very good. At what point is the efficacy high enough that you'd be willing to subject yourself to a possible reaction? Do realize that any gluten ingested increases your chance of disease, chief amongst them cancer and autoimmune disease. Is there a level of function of the drug that you would chance taking it? Is it 90%, 99%? Does any drug ever get that good? Well, as a big fan of Dr. Fasano's, I would say that if anyone can do it, he and his team can. But at the same time, I cannot help but think of all the other drugs I have encountered. As 'wonderful' as they sometimes seem initially, they almost always fall from grace when some horrible side effect is realized. Would I guinea pig my own health that I've fought so hard to regain? Would I recommend taking such a chance to my children just so that they could consume some white flour product? I don't think so. How about you? What do you think? If the drug were available right now at its efficacy of 71%, would you take it and hope you weren't in the 29% for whom it didn't work? I'd love to hear your thoughts. If you are wondering if you're gluten intolerant or know that you are but still aren't enjoying good health, consider calling us for a free health analysis: 408-733-0400. We are here to help! Our destination clinic sees patients from across the country and internationally so you do not need to live locally to receive assistance. To your good health! Reference: Alessio Fasano, Clinical and Developmental Immunology, Published online 2012 October 10. "Novel Therapeutic/Integrative Approaches for Celiac Disease and Dermatitis Herpetiformis."
  2. I found this easy-to-follow lecture by Dr. Fansano, a leading celiac researcher, regarding the implications of zonulin, (a newly found protein) that is involved in regulating intestinal permeability. It might be the cause of why we celiacs have so many varied intolerances to foods other than gluten! Better yet, zonulin might be linked to other autoimmune disorders. Here is his bio: https://celiac.org/provider/alessio-fasano-md/ Here is the video: No time to watch or you like reading scientific papers? http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3384703/ Enjoy!
  3. Celiac.com 05/14/2000 - Scientists from the University of Maryland have discovered that people with the autoimmune disorder celiac disease have higher levels of the protein zonulin in their bodies. This discovery may ultimately lead to more insight into the causes of other autoimmune diseases, including diabetes, multiple sclerosis and rheumatoid arthritis. In people with celiac disease who eat gluten, which is found in wheat, rye and barley, an autoimmune reaction is set off that creates antibodies that end up attacking their intestines. This causes symptoms like diarrhea and abdominal pain, and may lead to long-term damage and a large host of other problems. Researchers at the University of Maryland have finally found the cause of this curious reaction: a protein in the body called zonulin. Zonulin is a human protein that acts like a traffic conductor for the bodys tissues by opening spaces between cells, and allowing certain proteins to pass through, while keeping out toxins and bacteria. People with celiac disease have higher levels of zonulin, which apparently allows gluten to pass through the cells in their intestines, which triggers an autoimmune response in their bodies. Until now, researchers could never understand how a big protein like gluten could pass through the immune system. According to author Alessio Fasano, M.D., people with celiac have an increased level of zonulin, which opens the junctions between the cells. In essence, the gateways are stuck open, allowing gluten and other allergens to pass. Further: I believe that zonulin plays a critical role in the modulation of our immune system...(f)or some reason, the zonulin levels go out of whack, and that leads to autoimmune disease. Ultimately these finding may help doctors understand the causes of other, more severe autoimmune disorders.
  4. Celiac.com 11/08/2005 - Today a team of scientists at Alba Therapeutics Corporation (Alba) and the University of Maryland School of Medicine reported a direct link between gluten-induced intestinal permeability and zonulin in tissues from patients with celiac disease. The investigators were able to successfully prevent gluten-induced intestinal tissue leak with the administration of the zonulin antagonist FZI/0 (AT-1001). AT-1001 is an orally administered peptide currently under development for the treatment of celiac disease. Published in the November issue of the Scandinavian Journal of Gastroenterology, these results describe the role that leaky gut plays in celiac disease and the role that zonulin plays in establishing the leak. These results are another milestone towards understanding the role of zonulin in celiac disease, says Alessio Fasano, M.D., lead author of the paper, professor of pediatrics, medicine and physiology at the University of Maryland School of Medicine and director of its Center for Celiac Research. These results reinforce our conviction that AT-1001 has great therapeutic potential and we look forward to confirming these observations in celiac patients soon, stated Alba CEO Dr. Blake M. Paterson. About Zonulin Zonulin is a 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. Zonulin appears to be involved in many diseases 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 autoimmune diseases. 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. According to the National Institutes of Health, 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 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 other auto-immune illnesses. Contact: Dr. Blake Paterson Alba Therapeutics Corporation (410) 522-8708
  5. Celiac.com 02/25/2005 - Today a team of scientists at Alba Therapeutics Corporation and the University of Maryland School of Medicine report a direct link between zonulin-mediated increased intestinal permeability and Type 1 Diabetes (T1D) in the BB/wor Rat Model of Diabetes. Even more remarkable, the investigators were able to successfully prevent the onset of the autoimmune destruction of pancreatic beta cells and the onset of T1D in these animals by using the specific zonulin blocker AT-1001. Daily, oral administration of the drug beginning before the onset of auto-immunity in the diabetic prone rats cut the incidence of the disease by 2/3, and completely blocked the development of autoimmune antibodies in the treatment responders. Published in the latest issue of the Proceedings of the National Academy of Science (PNAS), these results constitute the first successful result in preventing the autoimmune process characteristic of T1D by blocking the zonulin-mediated abnormal intestinal permeability. These results go well beyond the development of a prevention strategy for T1D, says Dr. Alessio Fasano, lead author of the paper and Professor of Pediatrics, Medicine and Physiology and The University of Maryland School of Medicine. They open a new field of investigation in which the interplay between host and environment at the mucosal level may help us understanding the molecular basis of many diseases. These results reinforce our conviction that the zonulin pathway provides a roadmap for the discovery and development of innovative products to treat many important diseases, including diabetes, in ways previously thought to be inconceivable stated Dr. Blake M. Paterson. These preclinical proof-of-concept results with AT-1001 support the salvaging of beta cell function in pre-diabetics or in new-onset diabetes, giving us the impetus to rapidly move through the development process, bringing this dream to a reality for treatment in the diabetes community. T1D is an autoimmune disease that results in the destruction of the insulin producing cells of the pancreas, the islet beta cells. Current treatment of T1D is limited to the administration of insulin and other medications to treat the consequence of diabetes, elevated blood sugar and the complications thereof. The inability to treat the cause of T1D - a process known as autoimmunity, in which the bodys immune system attacks the beta cells of the pancreas - has been the key obstacle to the freeing patients from the yoke of this disease. Autoimmune diseases are thought to occur in individuals with the genetic pre-disposition to attack and destroy various organ tissues by the bodys own immune system. This immune misrecognition is thought to be triggered by the presence of an environmental stimulus; in the case of T1D, the trigger is unknown. While the majority of research efforts have focused on identifying the trigger of T1D and modifying immune pathways, little is known about how such a trigger might enter the body and about how such an entry-way might serve as a target for the treatment of the disease. The discovery of zonulin - a gatekeeper of intestinal barrier function, and its involvement in celiac disease, led to the hypothesis that its malfunction could be involved in a series of other autoimmune diseases characterized by a leaky gut, including T1D. Previous work by Dr. Alessio Fasano has shown a close association of celiac disease in children at risk of developing T1D and led to the novel discovery research in support of AT-1001. About Alba: Alba Therapeutics is a Baltimore based biopharmaceutical company 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 and is in the final stages of pre-human testing. Contact Alba Therapeutics Corporation, Baltimore Dr. Blake Paterson, 410-522-8708
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