Jump to content

  • 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

  • Record is Archived

    This article is now archived and is closed to further replies.

    Scott Adams
    Scott Adams

    By Scott Adams •

    Small Drug Firm Announces Completion of First Human Trial for AT-1001 and FDA 'Fast Track' Designation for Possible Future Celiac Disease Treatment

    Reviewed and edited by a celiac disease expert.

    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.

    Celiac.com Sponsor (A12):
    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 Open Original Shared Link

    Open Original Shared Link 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, Open Original Shared Link 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


     Share
    Go to articles

    User Feedback

    Recommended Comments

    There are no comments to display.



    Guest
    This is now closed for further comments

  • Get Celiac.com Updates:
    Support Celiac.com:
    Join eNewsletter
    Donate

  • About Me

    Scott Adams

    Scott Adams was diagnosed with celiac disease in 1994. Faced with a critical lack of resources, he dedicated himself to becoming an expert on the condition to achieve his own recovery.

    In 1995, he founded Celiac.com with a clear mission: to ensure no one would have to navigate celiac disease alone. The site has since grown into one of the oldest and most trusted patient-focused resources for celiac disease and the gluten-free lifestyle.

    His work to advance awareness and support includes:

    Today, Celiac.com remains his primary focus. To ensure unbiased information, the site does not sell products and is 100% advertiser supported.

    Scott Adams

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



    Celiac.com Sponsors (A17-M):



  • Related Articles

    Scott Adams
    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...
    Scott Adams
    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...
    Scott Adams
    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...
    Jefferson Adams
    Celiac.com 09/10/2007 - A study published recently in the journal of Alimentary Pharmacology and Therapeutics shows that the paracellular permeability inhibitor AT-1001 effectively reduces intestinal barrier dysfunction, proinflammatory cytokine production, and gastrointestinal symptoms in people who have celiac disease. At present, a lifetime devoted to following a strict gluten-free diet is the backbone of current treatment for celiac disease. However, as researchers have come to know more about celiac disease, they’re insights are leading to developments that offer more effective prognosis and treatment of the disease.
    One of those promising new approaches involves treating celiac patients with doses of AT-1001, a paracellular permeability inhibitor that is structurally d...

  • Recent Activity

    1. sleuth
      - sleuth replied to fatjacksonthecat's topic in Post Diagnosis, Recovery & Treatment of Celiac Disease
      22

      Nicotine Gum For Gluten Symptoms.. Am I Crazy?

      He is not just a psychiatrist. He is also a neuroscientist. And yes, I have already read those studies. I agree with benfotiamine. This is short term while glutened/inflammation occurs. As I had already mentioned, these symptoms no longer exist when this phase passes. And yes, I know that celiac is a disease of malnutrition. We are working with...
    2. knitty kitty
      - knitty kitty replied to fatjacksonthecat's topic in Post Diagnosis, Recovery & Treatment of Celiac Disease
      22

      Nicotine Gum For Gluten Symptoms.. Am I Crazy?

      Please do more research before you settle on nicotine. Dr. Paul New house is a psychiatrist. His latest study involves the effect of nicotine patches on Late Life Depression which has reached no long term conclusions about the benefits. Effects of open-label transdermal nicotine antidepressant augmentation on affective symptoms and executive...
    3. sleuth
      - sleuth replied to fatjacksonthecat's topic in Post Diagnosis, Recovery & Treatment of Celiac Disease
      22

      Nicotine Gum For Gluten Symptoms.. Am I Crazy?

      Thanks for your response. Everything you mentioned he is and has been doing. Tobacco is not the same as nicotine. Nicotine, in the form of a patch, does not cause gastrointestinal irritation. Smoking does. He is not smoking. Please do your research before stating false information. Dr. Paul Newhouse has been doing research on nicotine the last 40 years...
    4. Jmartes71
      - Jmartes71 posted a topic in Celiac Disease Pre-Diagnosis, Testing & Symptoms
      0

      Fighting for a name

      Im so frustrated and still getting the run around trying to reprove my celiac disease which my past primary ignored for 25 years.I understand that theres a ray of medical that doctors are limited too but not listening and telling the patient ( me) that im not as sensitive as I think and NOT celiac!Correction Mr white coat its not what I think but for cause...
    5. trents
      - trents replied to AnnK73's topic in Gluten-Free Foods, Products, Shopping & Medications
      32

      Celiac getting dentures

      @Martha Mitchell, your reaction to the lens implant with gluten sounds like it could be an allergic reaction rather than a celiac reaction. It is possible for a celiac to be also allergic to gluten as it is a protein component in wheat, barley and rye.
  • Celiac.com Sponsor (A19):


  • Member Statistics

    • Total Members
      132,017
    • Most Online (within 30 mins)
      7,748
    Sjcucinotta
    Newest Member
    Sjcucinotta
    Joined
  • Celiac.com Sponsor (A20):

  • Forum Statistics

    • Total Topics
      121.5k
    • Total Posts
      1m
  • Celiac.com Sponsor (A22):



  • Celiac.com Sponsor (A21):


  • Popular Now

    • JoJo0611
      6
      Chances of being coeliac

      By JoJo0611
      Started

    • Riley.
      5
      Outgrow celiac?

      By Riley.
      Started

    • tiffanygosci
      14
      New Celiac Mama in My 30s

      By tiffanygosci
      Started

    • AnnK73
      32
      Celiac getting dentures

      By AnnK73
      Started

  • Popular Articles

    • Scott Adams
      60
      The Gluten-Free Diet 101 - A Beginner's Guide to Going Gluten-Free

      By Scott Adams

    • Scott Adams
      144
      What Are the Symptoms of Celiac Disease?

      By Scott Adams

    • Scott Adams
      66
      Safe Gluten-Free Food List (Safe Ingredients)

      By Scott Adams

    • Scott Adams
      78
      Forbidden Gluten Food List (Unsafe Ingredients)

      By Scott Adams

    • Scott Adams
      72
      Gluten-Free Alcoholic Beverages

      By Scott Adams

  • Upcoming Events

×
×
  • Create New...

Important Information

NOTICE: This site places This site places cookies on your device (Cookie settings). on your device. Continued use is acceptance of our Terms of Use, and Privacy Policy.