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Found 12 results

  1. Celiac.com 01/14/2019 - There are a number of new drugs in development that are designed to treat celiac disease. In addition to a possible vaccine, those drugs include enzymes and other drugs that are designed to reduce or eliminate the body’s adverse reaction to gluten through various mechanisms. Here's a 2019 status update for every drug for treating celiac disease currently in development: ALV003—Created by Alvine Pharmaceuticals, is a combination of two enzymes that break down gluten before it can provoke an immune reaction. The drug is a powder to be dissolved in water and taken before meals. ALV003 passed a phase 2 clinical trial, and results were published in the June 2014 issue of Gastroenterology. Post-trial biopsies showed that ALV003 prevented intestinal damage in 34 volunteers with celiac disease, each of whom ate 2 grams of gluten per day for six weeks, in addition to taking ALV-003. Phase 2b, a 12-week trial, is now underway. AN-PEP (aspergillus niger prolyl endopeptidase)—Created by DSM Food Specialties, AN-PEP is another enzyme that degrades gluten. AN-PEP is believed to work best when taken while gluten is still in the stomach. A 2013 study showed AN-PEP to be safe, but failed to show that the enzyme had any effect, so further study is under way. That study appeared in the World Journal of Gastroenterology. In a 2018 study, AN-PEP extensively degraded gluten concentrations of up to 80,000 mg/kg in rye flour, rye sourdough, and sourdough starter under specific temperatures and pH values, while leaving the microorganisms in the sourdough starter fully intact. ActoBiotics—Created by ActoGenX uses Lactococcus lactis as an expression system to locally secrete bio-therapeutics such as cytokines, antibodies, hormones, etc. Early pre-clinical work with a genetically altered L. lactis secreting a peptide derived from gliadin demonstrated an in vivo suppression of gluten sensitization. Specifically, Huigbregtse et al. engineered L. lactis to secrete a deamidated DQ8 gliadin epitope (LL-eDQ8d) and studied the induction of Ag-specific tolerance in NOD ABo DQ8 transgenic mice [34]. Although apparently not part of the ActoGenX development program, recent work by Galipeau et al. also deserves mention in this context. The group treated gluten-sensitive mice with elafin, a serine protease inhibitor, delivered by the L. lactis vector, and found normalization of inflammation, improved permeability, and maintained ZO-1 expression. There is speculation that this is due to reduced deamidation of gliadin peptide. AVX176—Created by Avaxia Biologics, is an investigational oral antibody drug patented to provide "Antibody Therapy for Treatment of Diseases Associated with Gluten Intolerance." The patent, which expires on May 27 2029. AVX176 provides broad coverage for treating celiac disease using orally administered antibodies produced by Avaxia's proprietary platform technology. BL-7010—by BioLineRx, is a novel co-polymer for the treatment of celiac disease, which significantly reduces the immune response triggered by gluten. This drug has been shown in mice to reduce the immune system response that leads to intestinal damage and villous atrophy in celiac disease. BL-7010 actually binds to the gluten protein, reducing the protein's toxicity.The drug, with the gluten molecule attached, then passes harmlessly through the digestive system to be expelled as stool. BL-7010 has undergone safety testing in humans and was found to be well tolerated. According to BioLineRx, testing will begin in mid-2015 to see if the drug works as expected to diminish gluten's effects on the body. However, BL-7010 is designed to protect only against gluten cross-contamination; it won't allow people with celiac disease to eat large amounts of gluten. CCR9—by Chemocentryx, is a drug called vercirnon, which is also known as Traficet-EN, or CCX282B), and was originally intended for patients with moderate-to-severe Crohn's disease. CCR9 has completed one Phase 2 trial in 67 patients with celiac disease. However, despite the completion of the trial several years ago, no results relating to celiac disease have been made public or published. Egg Yolk Enzyme—Little is known about efforts to develop a celiac treatment that uses egg yolk to coat gluten and allow it to pass through the body undetected, thus preventing an adverse gluten reaction in sensitive individuals. Like most other drugs being developed, this treatment would work to prevent reactions to small amounts of gluten, rather than as a cure for celiac disease. Recent news shows that the egg yolk enzyme is safe for humans. GliadinX (Aspergillus niger)—GliadinX is a dietary supplement with the highest concentration of AN-PEP, Prolyl Endopeptidase (Aspergillus Niger), the most effective enzyme proven to break down gluten in the stomach. This high potency enzyme formulation is specifically designed to break down gliadin. GliadinX does not prevent or cure celiac disease. However, clinical research has shown that it effectively breaks down gliadin into small, harmless fragments before it can reach the small intestine. INN-202 (Larazotide Acetate)—Created by Alba Therapeutics and later acquired by Innovate Pharmaceutical, and renamed INN-202, larazotide acetate works by blocking a protein that carries pieces of gluten across the gut. Results of a phase 2 trial of larazotide acetate appear in the February 2015 edition of Gastroenterology. While INN-202 may greatly reduce the symptoms of gluten exposure in celiacs, it is unlikely that a permit consumption of unlimited amounts of gluten. The U.S. Food and Drug Administration (FDA) has fast-tracked the drug. Phase III clinical trials are currently underway. Results of the trial should be available soon. Nexvax2—Created by ImmusanT, Nexvax2 is touted as a vaccine, but works much like an allergy shot. Nexvax2 combines three proprietary peptides that elicit an immune response in celiac disease patients who carry the immune recognition gene HLA-DQ2. Similar to allergy shots, the vaccine is designed to reprogram gluten-specific T cells triggered by the patient's immune response to the protein. Nexvax2 exposes the immune system to gluten in a controlled way so that immune cells that are usually activated get turned off or eliminated. So far, Nexvax2 has completed a phase 1 trial showing it to be safe, and the company has begun Phase II trials on humans in Australia and New Zealand. Saliva Rothia—Researchers at the Henry M. Golden School of Dental Medicine were looking at how proteins in general break down in saliva when they discovered an enzyme in a bacterium called Rothia that pulverized gluten as if it were Pac Man. That happy accident has led to a new stream of study that has moved beyond petri dishes to study the effect of the so-called ‘subtilisin,’ or protein-ingesting enzyme on the tiny digestive systems of mice. In so doing, they have found another bacterium, B. subtilis, which produces an enzyme similar to the Rothia one and is already safely consumed in Japan in a fermented soybean dish called ‘natto.’ A 2018 Boston University report concludes that “oral Rothia bacteria to gliadin digestion and pharmaceutical modification can protect Sub-A from auto-digestion as well as from acidic insults, thus rendering the usefulness of coated subtilisins as a digestive aid for gluten degradation.” ZED1227—Created by Dr. Falk Pharma and Zedira recently announced the start of phase II clinical trials for the drug candidate ZED1227, a direct acting inhibitor of tissue transglutaminase. ZED1227 molecules work by targeting the dysregulated transglutaminase within the small intestine in order to suppress the immune response to gluten which drives the disease process. Sources: An Update on Every Celiac Disease Drug Currently in Development Inside The Race for a Celiac Disease Treatment Promising Celiac Disease Drugs in the Pipeline Development of drugs for celiac disease: review of endpoints for Phase 2 and 3 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 01/31/2014 - Drug company BioLineRx has announced trials of BL-7010, a drug for treating celiac disease. BL-7010 is a new, non-absorbable, orally available polymer with a high affinity for gliadins, the immunogenic proteins present in gluten that cause celiac disease. BL-7010 is intended to treat celiac disease by sequestering and effectively masking gliadins from enzymatic degradation and preventing the formation of immunogenic peptides that trigger the classic adverse immune reaction. The BL-7010 is then excreted with gliadin from the digestive tract, preventing the absorption of gliadin into the blood. The overall effect is to significantly reduce the immune response triggered by gluten. According to BioLineRX, pre-clinical studies have shown BL-7010 to be both safety and effective. BioLineRX's Phase 1/2 study is a two-part, both single and repeated, double-blind, placebo-controlled, dose escalation study of BL-7010 in up to 32 patients. The main goal is to gauge the safety of single and repeated increasing doses of BL-7010 in well-controlled celiac disease patients. They also hope to assess the results of systemic exposure, if any, of BL-7010 in the study patients. Source: Wall Street Journal Online
  4. Hi. Feeling very sick and in desperate need of help. About a year ago, my IBS-like symptoms were worse than they'd ever been, and I wasn't sure what I was doing wrong. I was eating copious amounts of gluten and wheat products every day - countless PB&J sandwiches, toast, cereals, pasta, etc. (I was a big wheat bread eater because I was a vegetarian, and PB&J is a convenient non-meat food to take to school for lunch.) The biggest issue for me was frequent gas and bloating. Other than that, I only had occasional diarrhea usually related to panic attacks, but I normally had one or two healthy poops a day. I thought I'd cut out gluten for awhile just to see if I felt better. I really did initially. I also lost about 10 lbs., probably because I was eating less overall, and compensating for the lack of starches in the bread with healthier options like fruits and veggies. I assume that's why I felt better at first. But then I kept having problems after awhile. It got to the point where I started cutting out food group after food group, growing more and more paranoid that it was this or that. I lost 20 more lbs. unintentionally, then lost more intentionally, because this stuff is a sick cycle, and I'm now underweight and fatigued all the time. I eventually went to see a gastroenterologist as a last desperate effort to diagnose my problem. He did an endoscopy, took biopsies, took a blood test, and a stool sample. All of them came back negative for Celiac disease or gluten intolerance. I had not been eating gluten or wheat for almost a whole year at this point, though. I've read that this makes a difference. Does not having any gluten in your system guarantee a false negative? Anyway, after he told me the 'good' news that there was absolutely nothing wrong with me, I felt a bit encouraged. I was at that point (and still am) a vegan, so being a gluten-free vegan left me with not a lot of food options. Funny enough, going vegan was the best thing for me as far as managing my symptoms. All of the symptoms that going gluten free didn't cure were pretty much cured by going vegan. So, I've been wanting to eat more normally, and since my doc gave me the OK, I've been trying to slowly reintroduce gluten into my diet again. The results: First time, had half a slice of whole grain bread - felt okay for the first few hours, but later that night it felt like I'd swallowed a potato whole. Bloated, nauseous, and miserable. Second time, had a tiny handful of bran flakes. Same effects, but less severe. Third and fourth time - had some small pieces of whole grain crackers, felt no reaction except for a bit of bloating. Very mild. Fourth, fifth, and sixth times - had half to a full slice of whole wheat bread with fruit and peanut butter and some tea with ginger and peppermint to ease the transition. No stomach cramps this time and slightly less bloating, but I got very constipated. Then I took a laxative and some fiber supplements and even an enema (because I can't stand the feeling of being constipated, even for just a day; I'm such a baby), and I actually had to leave work early because I'm going to the bathroom every few minutes, ughghh. I know. I overdid it. What's going on? I'm clearly reacting to either the wheat or the gluten or both, but I don't know if it's because I'm legitimately gluten intolerant or sensitive or if it's because it's just a shock to my body after not eating it for so long. (I can eat heaps of non gluten-free oatmeal and have no adverse reaction at all.) I'm going to give my body a little break for a few days, and then maybe try eating a bit of bread again to see if I get used to it. I'm pretty upset. Going gluten-free was probably the worst decision of my life, because I was processing it without much problem before, and now I react so badly to it. It's really an issue because I can't tell you how much I miss sandwiches, and I can't find gluten-free and vegan-friendly bread anywhere. My doctor really got my hopes up, and now I'm feeling really discouraged. My family seems to think that I should stick with my original plan of gradually reintroducing gluten into my diet to get myself used to it again, which I felt like was possible since my stomach cramps went away eventually. My questions are: do you think there is any getting used to it? If so, do you have any tips on how to go about doing this? Is it possible my doctor misdiagnosed me? Did I "sensitize" myself to gluten or wheat by eating so damn much of it before? Not one person in my family has Celiac disease or is gluten sensitive or intolerant, so I don't have the genes for it. I'm just praying I can eat bread again someday. Am I in denial?
  5. Celiac.com 07/23/2012 - At 2012 Digestive Diseases Week in San Diego, California, Alvine Pharmaceuticals, Inc. announced the publication of data from Phase 2A trial of its main celiac disease compound, ALV003. The results show that ALV003, orally administered to celiac disease patients on a gluten free diet, significantly reduces gluten-triggered intestinal mucosal damage. For the trial, 41 adults with clinically proven celiac disease who had followed a gluten-free diet for at least one year were randomly given ALV003 or a placebo each day for six weeks. During that time, they also received 2g of gluten in the form of bread crumbs. Participants received a small bowel biopsy prior to randomization and again, at the end of the six week challenge. The results showed that the study met its primary endpoint of a clinically and statistically meaningful reduction in intestinal mucosal damage in celiac patients on a gluten-free diet. Damage was measured by the ratio of the villus height to crypt depth, or Vh:celiac disease between the ALV003 and placebo treated groups over the six week study period. Secondary endpoints included change in intraepithelial lymphocyte (IEL) density, gastrointestinal symptoms as measured by Gastrointestinal Symptom Rating Scale (GSRS) scores, celiac serologies, safety and tolerability. Each subject received small bowel biopsy at the start of the trial, and again after six weeks of daily gluten challenge. When researchers compared biopsy results from 34 patients, they found significantly less small intestinal mucosal damage in patients treated with ALV003 than in placebo-treated patients (p=0.013). Placebo-treated patients suffered worse damage and symptoms. Most often, these included abdominal distention, flatulence, eructation, abdominal pain and diarrhea. The published data shows that: Biopsy results for patients who received ALV003 had significantly reduced small intestinal mucosal damage compared with placebo-treated patients (p=0.0133). For placebo-treated patients, IELs, including CD3+ and CD3+ aB and subsets, which measure cellular inflammation responses, were significantly higher, but were mostly normal in the ALV003-treated patients. ALV003-treated patients had better overall GSRS scores and scores for indigestion and abdominal pain symptoms, compared with placebo-treated patients, though the results were not statistically significant. Patients reported no serious adverse events, however, placebo-treated patients reported more regular and consistent non-serious adverse. Such events that occurred in 10 percent or more patients included abdominal distention, flatulence, eructation, diarrhea, nausea, headache and fatigue. Celiac-disease blood tests revealed no significant changes between the ALV003 and placebo-treated patients, though results did show positive trends for tissue transglutaminase and deamidated gliadin peptide antibody titers in the ALV003-treated group, which indicates improved immune response. Daniel Adelman, M.D., Alvine's Senior Vice President and Chief Medical Officer, says that the trial results represent the first time that any such treatment for celiac disease has met its pre-specified primary endpoint of providing protection against damage from gluten-exposure in celiac disease patients, with data that is both clinically and statistically significant. Such a drug could help to protect gluten-free celiac disease patients against accidental gluten contamination. The company plans to initiate a Phase 2B trial later this year. Read the abstract of the presentation (Sa1342) on the DDW website. Review information on Alvine's current clinical trial titled "Evaluation of Patient Reported Outcome Instruments in Celiac Disease Patients" at the NIH website.
  6. 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
  7. Celiac.com 04/09/2011 - A Durham, North Carolina man is currently on trial for fraud after being accused of deliberately selling bread labeled gluten-free that contained gluten, and which sickened more than two dozen people with food allergies. According to a Wake County prosecutor, the man, Paul Seelig, owner of Great Specialty Products, repeatedly lied to customers about the ingredients in his bread. Seelig faces more than two dozen fraud charges for taking customers' money under false pretenses. Prosecutors plan to call almost 50 witnesses. Prosecutor Evans told jurors that witnesses would include two dozen customers who suffer from celiac disease and gluten intolerance, and who became ill after eating Seelig's products, along with the University of Nebraska experts who tested the bread. Evans said a former employee would testify that Seelig told her to lie to investigators about their operation, and that, during the State Fair, Seelig sent her and other workers to buy standard bagels at Costco and B.J.'s that Seelig's operation sold as gluten-free. "What this case is about is misrepresentations built on top of misrepresentations that this defendant made to people with medical conditions," Assistant District Attorney Shawn Evans said Tuesday during opening arguments in the trial. "The consequence was that many people got sick." According to prosecutors, Seelig knowingly misrepresented his bread as handmade, prepared in a dedicated gluten-free facility, and tested weekly for gluten contamination. Defense lawyer Blake Norman of Durham says Seelig, who reportedly suffers from Crohn's disease and cannot eat gluten, is merely a businessman who was looking to offer "reasonably priced gluten-free products" for consumers who suffer from food allergies. Norman also told jurors that Seelig would take the stand to tell his side of the story. However, Seelig might face an uphill battle for credibility if his criminal past comes under scrutiny. He has spent time in prison for two separate criminal convictions, the first for grand theft in 1991, which sent him to prison for more than two years, and a second in 2002, when Seelig was convicted in federal court of wire fraud and sentenced to four months in prison followed by three years of federal probation. If convicted of all the charges in the Wake County cases, Seelig, 48, faces at least eight years in prison if sentenced to consecutive terms. Source: Newsobserver
  8. 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
  9. 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
  10. Celiac.com 03/14/2006 - Alba Therapeutics Corporation announced today successful completion of Phase Ib proof-of-concept studies for its lead compound, AT1001. In a 21-patient cohort of celiac disease sufferers, the oral administration of AT1001 versus placebo control induced a significantly positive result in the trials primary target endpoint. "We anticipated a strong signal, however, the magnitude of the response surpassed our expectations," stated Blake Paterson, M.D., President and CEO of Alba. "We are particularly excited, as to the best of our knowledge this is the first demonstration of a desired and systemic immunological effect resulting from a physiological event at a mucosal surface." AT1001 is an antagonist to the zonulin system -- a signaling pathway discovered by Alessio Fasano, M.D., Professor of Pediatrics, Medicine and Physiology at the University of Maryland School of Medicine, and the basis of Albas extensive intellectual property portfolio. 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 (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 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. 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: Heather Bakalyar, 410-522-8708 x1106
  11. 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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