Jump to content
This site uses cookies. Continued use is acceptance of our Terms of Use and Privacy Policy. More Info... ×
  • Welcome to Celiac.com!

    You have found your celiac tribe! Join us and ask questions in our forum, share your story, and connect with others.




  • Celiac.com Sponsor (A1):



    Celiac.com Sponsor (A1-M):


  • Get Celiac.com Updates:
    Support Our Content
    eNewsletter
    Donate
    1. sc'Que?

      sc'Que?

  • Get Celiac.com Updates:
    Support Celiac.com:
    Donate
  • About Me

    Jefferson Adams

    Jefferson Adams is Celiac.com's senior writer and Digital Content Director. He earned his B.A. and M.F.A. at Arizona State University. His articles, essays, poems, stories and book reviews have appeared in numerous magazines, journals, and websites, including North American Project, Antioch Review, Caliban, Mississippi Review, Slate, and more. He is the author of more than 2,500 articles on celiac disease. His university coursework includes studies in science, scientific methodology, biology, anatomy, physiology, medicine, logic, and advanced research. He previously devised health and medical content for Colgate, Dove, Pfizer, Sharecare, Walgreens, and more. Jefferson has spoken about celiac disease to the media, including an appearance on the KQED radio show Forum, and is the editor of numerous books, including "Cereal Killers" by Scott Adams and Ron Hoggan, Ed.D.

    >VIEW ALL ARTICLES BY JEFFERSON ADAMS

     


  • Celiac.com Sponsor (A17):
    Celiac.com Sponsor (A17):





    Celiac.com Sponsors (A17-M):




  • Related Articles

    Jefferson Adams
    Promising Celiac Disease
    Celiac.com 07/01/2019 - Drugmakers have pulled the plug on a phase II trial of Nexvax2, a promising drug for treating celiac disease. Pharmaceutical company ImmusanT, said that "results from an interim analysis revealed Nexvax2 did not provide statistically meaningful protection from gluten exposure for celiac disease patients when compared with placebo."
    That's a lot of fancy language to say that the drug simply didn't work. It did no better than a placebo. If there were any other way to spin it, the company would have spun it. They didn't. That basically means total failure.
    We've written about Nexvax2 over the years, and followed it through its development. It was promising enough to earn fast-track development status by the FDA.
    The company's press release reads...


    Kelly Carter
    A Participant's Perspective on the Failure of the Nexvax2
    Celiac.com 07/09/2019 - Everyone in the Celiac community has read the press release about ImmusanT stopping the Phase 2 clinical trial of their drug Nexvax2. The drug was going to modify the immune system to ignore gluten. The hope was no more worries about cross contamination! However, in late June, ImmusanT issued a press release stating, "Nexvax2 did not provide statistically meaningful protection from gluten exposure for celiac disease patients when compared with placebo." Wait what?
    Let's go back a bit and talk about my experience in the clinical trial.
    I was in the Nexvax2 clinical trial. It consisted of five phases. The first phase was screening where they got all of your medical records that confirmed a celiac diagnosis and a gluten challenge. The gluten challenge ...


    Jefferson Adams
    FDA Issues New Guidelines for Celiac Drug Trials
    Celiac.com 07/04/2022 - The Food and Drug Administration (FDA) has issued a set of new guidelines for companies doing celiac disease drug trials. The agency noted that the guidance is intended only to provide clarity regarding existing requirements, and should be viewed solely as recommendations, unless they mention specific regulations or laws.
    The FDA directs sponsors of trials for clinical drugs to ensure the following regarding celiac disease patients on a gluten-free diet:
    Trial population
    Patients should undergo diagnostic esophagogastroduodenoscopy, with multiple biopsies to confirm celiac diagnosis. The biopsies should include one or two samples of the duodenal bulb and at least four samples of the distal duodenum.
    To avoid inclusion of patients whose ...


    Jefferson Adams
    Once Promising Celiac Drug Larazotide Looks Doomed After Disappointing Phase 3 Trial
    Celiac.com 07/18/2022 - Currently, a gluten-free diet is the only treatment for people with celiac disease. A number of companies have been attempting to create treatments that reduce or eliminate celiac disease symptoms, mostly for patients on a gluten-free diet. 
    Larazotide, whose clinical trial is dubbed "CedLara," is such a drug. It's designed to reduce persistent celiac disease symptoms for people on a gluten-free diet. 
    In an earlier phase 2 trial, Larazotide was shown to reduce celiac symptoms in patients who had been on a gluten-free diet for at least 12 months. Many were excited to see how it would do in a phase 3 trial. The answer, unless we get some better news from 9 Meters Biopharma, the company that has been developing it, is badly.
    For the phase 3 t...


  • Recent Activity

    1. - Kwinkle replied to Kwinkle's topic in Coping with Celiac Disease
      5

      I’m so confused…

    2. - Deanne jones replied to Matt13's topic in Celiac Disease Pre-Diagnosis, Testing & Symptoms
      28

      Can food allergies like milk and soy flatten villi?

    3. - knitty kitty replied to DayaInTheSun's topic in Coping with Celiac Disease
      12

      Being a burden to family/friends

    4. - Celiacandme replied to Kwinkle's topic in Coping with Celiac Disease
      5

      I’m so confused…

    5. - lmemsm replied to jasoncrest's topic in Gluten-Free Recipes & Cooking Tips
      4

      Recipe Apps?


  • Celiac.com Sponsor (A19):



  • Member Statistics

    • Total Members
      127,279
    • Most Online (within 30 mins)
      7,748

    Deborah Pepin
    Newest Member
    Deborah Pepin
    Joined

  • Celiac.com Sponsor (A20):


  • Forum Statistics

    • Total Topics
      121k
    • Total Posts
      70.1k

  • Celiac.com Sponsor (A22):





  • Celiac.com Sponsor (A21):



  • Popular Now

    • Kwinkle
      5
    • RobHicks
      6
    • ellyelly
      4
    • trsprecker
    • TerryinCO
      14
  • Popular Articles

    • Scott Adams
    • Scott Adams
    • Scott Adams
    • Scott Adams
    • Scott Adams
  • Upcoming Events

×
×
  • Create New...