Jump to content

Search the Community

Showing results for tags 'phase'.



More search options

  • Search By Tags

    Type tags separated by commas.
  • Search By Author

Content Type


Celiac Disease & Gluten-Free Diet Forums

  • Diagnosis & Recovery, Related Disorders & Research
    • Calendar of Events
    • Celiac Disease Pre-Diagnosis, Testing & Symptoms
    • Post Diagnosis, Recovery & Treatment of Celiac Disease
    • Related Disorders & Celiac Research
    • Dermatitis Herpetiformis
    • Gluten Sensitivity and Behavior
  • Support & Help
    • Coping with Celiac Disease
    • Publications & Publicity
    • Parents' Corner
    • Gab/Chat Room
    • Doctors Treating Celiac Disease
    • Teenagers & Young Adults Only
    • Pregnancy
    • Friends and Loved Ones of Celiacs
    • Meeting Room
    • Celiac Disease & Sleep
    • Celiac Support Groups
  • Gluten-Free Lifestyle
    • Gluten-Free Foods, Products, Shopping & Medications
    • Gluten-Free Recipes & Cooking Tips
    • Gluten-Free Restaurants
    • Ingredients & Food Labeling Issues
    • Traveling with Celiac Disease
    • Weight Issues & Celiac Disease
    • International Room (Outside USA)
    • Sports and Fitness
  • When A Gluten-Free Diet Just Isn't Enough
    • Food Intolerance & Leaky Gut
    • Super Sensitive People
    • Alternative Diets
  • Forum Technical Assistance
    • Board/Forum Technical Help
  • DFW/Central Texas Celiacs's Events
  • DFW/Central Texas Celiacs's Groups/Organizations in the DFW area

Celiac Disease & Gluten-Free Diet Blogs

There are no results to display.

There are no results to display.

Categories

  • Celiac.com Sponsors
  • Celiac Disease
  • Safe Gluten-Free Food List / Unsafe Foods & Ingredients
  • Gluten-Free Food & Product Reviews
  • Gluten-Free Recipes
    • Recipes by Continent / Country
    • Biscuits, Rolls & Buns (Gluten-Free Recipes)
    • Noodles & Dumplings (Gluten-Free Recipes)
    • Dessert Recipes: Gluten-Free Pastries, Cakes, Cookies, etc.
    • Bread Recipes (Gluten-Free)
    • Flour Mixes (Gluten-Free)
    • Kids Recipes (Gluten-Free)
    • Snacks & Appetizers (Gluten-Free Recipes)
    • Muffins (Gluten-Free Recipes)
    • Pancakes (Gluten-Free Recipes)
    • Pizzas & Pizza Crusts (Gluten-Free Recipes)
    • Soups, Sauces, Dressings & Chowders (Gluten-Free Recipes)
    • Cooking Tips
    • Scones (Gluten-Free Recipes)
    • Waffles (Gluten-Free Recipes)
  • Celiac Disease Diagnosis, Testing & Treatment
  • Celiac Disease & Gluten Intolerance Research
  • Miscellaneous Information on Celiac Disease
    • Additional Celiac Disease Concerns
    • Celiac Disease Research Projects, Fundraising, Epidemiology, Etc.
    • Conferences, Publicity, Pregnancy, Church, Bread Machines, Distillation & Beer
    • Gluten-Free Diet, Celiac Disease & Codex Alimentarius Wheat Starch
    • Gluten-Free Food Ingredient Labeling Regulations
    • Celiac.com Podcast Edition
  • Journal of Gluten Sensitivity
  • Celiac Disease & Related Diseases and Disorders
  • Origins of Celiac Disease
  • Gluten-Free Grains and Flours
  • Oats and Celiac Disease: Are They Gluten-Free?
  • Frequently Asked Questions
  • Celiac Disease Support Groups
  • Celiac Disease Doctor Listing
  • Kids and Celiac Disease
  • Gluten-Free Travel
  • Gluten-Free Cooking
  • Gluten-Free
  • Allergy vs. Intolerance
  • Tax Deductions for Gluten-Free Food
  • Gluten-Free Newsletters & Magazines
  • Gluten-Free & Celiac Disease Links
  • History of Celiac.com

Find results in...

Find results that contain...


Date Created

  • Start

    End


Last Updated

  • Start

    End


Filter by number of...

Joined

  • Start

    End


Group


AIM


MSN


Website URL


ICQ


Yahoo


Jabber


Skype


Interests


Location


First Name


Last Name


City


State


Country


How did you hear about us?

Found 6 results

  1. Celiac.com 04/18/2015 - Research is underway on a number of new drugs intended to celiac disease treatment beyond a simple gluten-free diet. However, even though several drugs are in Phase 2 trials and results appear promising, discussion around regulatory endpoints is just beginning. A research team recently reviewed endpoints for Phase 2 and 3 trials of new celiac disease drugs currently under development, and detailed their results in a scientific paper. The team included Klaus Gottlieb, Jill Dawson, Fez Hussain and Joseph A. Murray. They are variously affiliated with the department of Immunology and Internal Medicine of Medical Strategy & Science, Quintiles, Durham, NC, USA, with Corporate Communications, Quintiles, Durham, NC, USA, and with the Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN, USA. In the paper, the team discusses celiac drugs currently under development, along with trial endpoints, such as patient-reported outcomes, histology, serology, gene expression analysis and other tests. They outline the differing requirements for proof-of-concept Phase 2 trials and Phase 3 registration trials, with a particular emphasis on current thinking in regulatory agencies. They conclude their paper with recommendations and a glossary of regulatory terms, to enable readers who are less familiar with regulatory language to take maximum advantage of this review. Stay tuned for more news and information on all developments concerning trials of new celiac drug treatments. Source: Gastroenterology Report, Oxford Journals. 10.1093/gastro/gov006
  2. 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
  3. 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
  4. 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
  5. Celiac.com 03/19/2009 - Numerate Inc., a biotechnology company leveraging a novel drug engineering process to design lead-stage drug compounds, announced today it has received a Phase 1 grant from the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health (NIH). The Small Business Technology Transfer (STTR) award, entitled “Drug Engineering of Transglutaminase 2 Inhibitors,” will be used to support a research collaboration between Numerate and the laboratory of Chaitan Khosla, Ph.D., the Wells H. Rauser and Harold M. Petiprin Professor of Chemical Engineering and Chemistry at Stanford University. “This NIH Phase 1 STTR award validates the attractiveness of Numerate’s drug engineering process for the design of new small molecule drugs,” stated John Griffin, Ph.D., Numerate’s chief scientific officer and principal investigator of the project. “In addition, it recognizes the potential of transglutaminase 2 inhibitors for the treatment of Celiac Sprue. Professor Khosla is a leader in Celiac disease research, and we are pleased to have the support of the NIH in our collaboration with him and his laboratory.” Professor Khosla, who will serve as co-investigator for the STTR research project, added, “Transglutaminase 2 is central to the pathophysiology of Celiac Sprue, and offers a compelling target for a disease for which no pharmacotherapy currently exists. I look forward to having Numerate apply its breakthrough technology to this important problem.” Celiac Sprue, also known as celiac disease, is an autoimmune disorder of the small intestine involving intolerance to gluten proteins found in wheat and other grains. About Numerate Numerate is a privately held biotechnology company that has developed and extensively validated a drug engineering process that rapidly and cost-effectively delivers small molecule drug candidates optimized for efficacy, safety, and patentability. Numerate’s drug engineering process combines advances in computer science, statistics, and molecular modeling to address, in parallel, the factors that determine the success and failure of a drug. Numerate applies this proprietary process to design and develop small molecule therapeutics in collaboration with a variety of partners in the pharmaceutical and biotechnology fields. For more information, please visit www.numerate.com.
  6. 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
×
×
  • Create New...