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
  • Record is Archived

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

    Scott Adams
    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



    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:
    Donate
  • About Me

    Scott Adams

    Scott Adams was diagnosed with celiac disease in 1994, and, due to the nearly total lack of information available at that time, was forced to become an expert on the disease in order to recover. In 1995 he launched the site that later became Celiac.com to help as many people as possible with celiac disease get diagnosed so they can begin to live happy, healthy gluten-free lives.  He is co-author of the book Cereal Killers, and founder and publisher of the (formerly paper) newsletter Journal of Gluten Sensitivity. In 1998 he founded The Gluten-Free Mall which he sold in 2014. Celiac.com does not sell any products, and is 100% advertiser supported.


  • 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. - Scott Adams replied to Vozzyv's topic in Celiac Disease Pre-Diagnosis, Testing & Symptoms
      5

      Weird Symptoms

    2. - Jeff Platt replied to Vozzyv's topic in Celiac Disease Pre-Diagnosis, Testing & Symptoms
      5

      Weird Symptoms

    3. - cristiana replied to Vozzyv's topic in Celiac Disease Pre-Diagnosis, Testing & Symptoms
      5

      Weird Symptoms

    4. - Scott Adams replied to More2Learn's topic in Celiac Disease Pre-Diagnosis, Testing & Symptoms
      1

      Celiac Maybe a Possibility?

    5. - More2Learn posted a topic in Celiac Disease Pre-Diagnosis, Testing & Symptoms
      1

      Celiac Maybe a Possibility?


  • Celiac.com Sponsor (A19):



  • Member Statistics

    • Total Members
      126,104
    • Most Online (within 30 mins)
      7,748

    Gay Britton
    Newest Member
    Gay Britton
    Joined

  • Celiac.com Sponsor (A20):


  • Forum Statistics

    • Total Topics
      120.9k
    • Total Posts
      69.2k

  • Celiac.com Sponsor (A22):





  • Celiac.com Sponsor (A21):



  • Popular Now

    • Vozzyv
      5
    • Kathleen JJ
    • Captain173
      10
    • jjiillee
      7
    • Kristina12
      7
  • Popular Articles

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

×
×
  • Create New...