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      Frequently Asked Questions About Celiac Disease   04/07/2018

      This Celiac.com FAQ on celiac disease will guide you to all of the basic information you will need to know about the disease, its diagnosis, testing methods, a gluten-free diet, etc.   Subscribe to Celiac.com's FREE weekly eNewsletter   What are the major symptoms of celiac disease? Celiac Disease Symptoms What testing is available for celiac disease?  Celiac Disease Screening Interpretation of Celiac Disease Blood Test Results Can I be tested even though I am eating gluten free? How long must gluten be taken for the serological tests to be meaningful? The Gluten-Free Diet 101 - A Beginner's Guide to Going Gluten-Free Is celiac inherited? Should my children be tested? Ten Facts About Celiac Disease Genetic Testing Is there a link between celiac and other autoimmune diseases? Celiac Disease Research: Associated Diseases and Disorders Is there a list of gluten foods to avoid? Unsafe Gluten-Free Food List (Unsafe Ingredients) Is there a list of gluten free foods? Safe Gluten-Free Food List (Safe Ingredients) Gluten-Free Alcoholic Beverages Distilled Spirits (Grain Alcohols) and Vinegar: Are they Gluten-Free? Where does gluten hide? Additional Things to Beware of to Maintain a 100% Gluten-Free Diet What if my doctor won't listen to me? An Open Letter to Skeptical Health Care Practitioners Gluten-Free recipes: Gluten-Free Recipes
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Celimmune Commences First-Ever Dosing with AMG 714 in Celiac Disease

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Celimmune LLC, a clinical development-stage immunotherapy company focused on treating and preventing immune-mediated diseases, announced that it has dosed the first patient in its Phase 2 clinical study for AMG 714 in celiac disease. AMG 714 is an investigational anti-IL-15 monoclonal antibody being studied for the treatment of gluten-free diet non-responsive celiac disease (NRCD) and refractory celiac disease Type II (RCD-II). The celiac disease study is being conducted by several expert academic medical centers in Tampere, Oulu, and Turku, Finland, a country where the incidence and understanding of celiac disease ranks among the highest in the world.

Image: CC--Counselman CollectionThe randomized, double-blind, placebo-controlled, parallel-group study is expected to enroll 63 patients with a diagnosis of celiac disease confirmed by intestinal biopsy at least 12 months prior to screening. The study will evaluate the efficacy and safety of AMG 714 for the attenuation of the effects of gluten exposure in adult patients with celiac disease during a gluten challenge. Study duration is 20 weeks and visits to the site take place every two weeks.

Francisco Leon, M.D., Ph.D., CEO and Chief Medical Officer of Celimmune, commented, "Dosing the first celiac disease patient with AMG 714 is an important milestone for our company and an exciting step forward in the endeavor to find much-needed therapeutic treatment options for celiac disease when the gluten-free diet is not effective and for refractory celiac disease type II (RCD-II). We have chosen Finland for the excellence of its celiac research, its efficient clinical research community and its generous celiac patients, at the forefront of advancing the field."

Markku Maki, professor and celiac disease researcher at Tampere University and University Hospital of Tampere, and an eminent figure in the field of celiac disease, commented, "AMG 714 is the first experimental therapeutic for celiac disease designed to block IL-15. We believe this approach to treating celiac disease has strong potential and look forward to continuing the enrollment of this study and evaluating the results to further our understanding of celiac disease."

AMG 714 is a human immunoglobulin monoclonal antibody that binds to IL-15 and neutralizes its effects. IL-15 is considered to have a central role in celiac disease and to be a key driver of the generation of aberrant and malignant intraepithelial lymphocytes (IELs) in RCD-II. In four previous clinical studies, AMG 714 has been well tolerated by healthy volunteers, as well as by patients diagnosed with rheumatoid arthritis or psoriasis.

NRCD is defined as persistent symptoms, elevated celiac antibodies, or small intestinal damage following 6-12 months on a strict gluten-free diet. In most cases, NRCD is caused by unintentional gluten exposure from unrecognized gluten-containing products, such as foods believed to be, or labeled, gluten-free, or non-food products such as medications or household items (e.g. toothpaste, lipstick).

To learn more about Celimmune, AMG 714 or our Phase 2 clinical studies, visit www.celimmune.com or www.clinicaltrials.gov:

Celiac Disease:
ClinicalTrials.gov Identifier: NCT02637141
https://clinicaltrials.gov/ct2/show/NCT02637141?term=NCT02637141&rank=1
Refractory Celiac Disease Type II:
ClinicalTrials.gov Identifier: NCT02633020
https://clinicaltrials.gov/ct2/show/NCT02633020?term=NCT02633020&rank=1

About Celimmune
Celimmune, LLC is a clinical development-stage immunotherapy company focused on treating and preventing immune-mediated diseases and is headquartered in in Lebanon, New Jersey, and Bethesda, Maryland. Celimmune will initially focus its distinctive core competence in translational medicine, immunotherapy clinical development and commercialization on combating celiac disease and other serious immune-mediated diseases. Celimmune has an exclusive licensing agreement with Amgen to develop, manufacture and commercialize AMG 714, a Phase 2-stage anti-IL-15 monoclonal antibody.

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