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  • Dr. Jennifer Sealey Voyksner
    Dr. Jennifer Sealey Voyksner

    ImmunogenX Continues Developing New Treatment Options for Celiac Disease

    Reviewed and edited by a celiac disease expert.

    Jennifer A. Sealey-Voyksner, PhD Chief Scientific Officer and Co-Founder of ImmunogenX provides a progress update on a potential new treatment for celiac disease.

    ImmunogenX Continues Developing New Treatment Options for Celiac Disease - Image: CC--Idaho National Laboratory
    Caption: Image: CC--Idaho National Laboratory

    Celiac.com 08/11/2017 - We are very pleased to provide an exciting update on our progress on bringing our therapeutic drug "latiglutenase" and our diagnostic disease management tool "CypCel" to market for patients suffering with celiac disease.

    ImmunogenX is a clinical-stage company founded by dedicated scientists committed to bettering the lives of celiac disease patients. We are focused on celiac disease therapy, disease management and food safety. We acquired the assets of Alvine Pharmaceuticals in 2016 and are marching ahead with great confidence and enthusiasm and plan to start our final Phase 2 trial for latiglutenase later this year.



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    Latiglutenase is a natural product, a mixture of two gluten-specific enzymes that break down gluten in the stomach. A patient would take the therapy orally while maintaining a strict gluten-free diet. The intent of the therapy is to combat low levels of gluten that persist in the food chain, as well as in situations where ingestion of gluten is unavoidable due to cross contamination, such as at restaurants.

    The recent latiglutenase Phase 2b trial (CeliAction) conducted by Alvine and AbbVie unfortunately did not meet their primary goal of demonstrating clinically significant intestinal healing. The secondary goal of symptom reduction did show evidence of success in a subclass of celiac disease patients. ImmunogenX, following the acquisition of the Alvine assets, completed a post hoc data analysis from this trial. Statistically and clinically significant symptom improvement was shown for abdominal pain, bloating, tiredness, and constipation for patients who had persistent positive readings in key antibody levels (i.e., seropositive). These exciting results were highlighted at the Digestive Disease Week meeting in May 2017 and are now published in Digestive Diseases and Sciences. We will travel to India in September to present our research at ICDS 2017 (International Celiac Disease Symposium).

    If the primary endpoint of the CeliAction trial had been focused on reducing symptoms of gluten exposure, then that trial could rightfully have been called a success. Therefore, as a next step, ImmunogenX will be to go back into the clinic and reconfirm these positive results, demonstrating symptom improvement, in our next phase 2 trial. This will enable the company to transition to a pivotal trial for FDA registration.

    We attended another FDA Type C meeting in May 2017, which reinforced the continuing positive support from the agency regarding our symptom label, our Phase 2/3 trial strategy and our celiac disease symptom diary (CDSD) patient reported outcome (PRO) instrument. It is very gratifying to have such documented support from the FDA for our mission.

    Please visit our website www.immunogenx.com for updates on our progress and feel free to contact us with any questions (info@immunogenx.com).



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    Thank you for reporting negative results! These are incredibly important in steering research toward success. And congrats on the positive results your team has made. Millions of celiacs are looking forward with hope to what labs like yours will produce.

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    So, this article is saying they are going for symptom relief not blocking actual damage done? Long term effects of malnutrition from damaged villi can lead to life threatening and debilitating symptoms, and the damage can lead, also, to cancer. This does not sound like anything a person with celiac should rely on for actual health, so why is it being called a celiac treatment?

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    So, this article is saying they are going for symptom relief not blocking actual damage done? Long term effects of malnutrition from damaged villi can lead to life threatening and debilitating symptoms, and the damage can lead, also, to cancer. This does not sound like anything a person with celiac should rely on for actual health, so why is it being called a celiac treatment?

    Their approach would prevent the damage as well.

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  • About Me

    Dr. Jennifer Sealey Voyksner

    Jennifer has 30 years of experience in government and industry-based R&D. She is a pioneering mass spectrometrist focused on allergenic protein marker discovery and allergenic protein analysis. She is the CSO and co-founder of ImmunogenX™, a biopharmaceutical company focused on developing therapies and diagnostics for autoimmune and gastrointestinal diseases. Most recently, she was a co-founder and Director of R&D of LCMS Limited in North Carolina, an independent analytical laboratory.

    Jennifer was diagnosed with celiac disease in 2002. This is an autoimmune disease related to ingestion of dietary gluten, for which there is no cure. She has since dedicated her professional and business career to bettering the lives of those who suffer from food-related diseases.


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    Jefferson Adams
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    Read more: Dig Dis Sci. 2017 Doi:10.1007/s10620-017-4687-7.


    Jefferson Adams
    Celiac.com 10/02/2017 - For anyone following the efforts by ImmusanT to develop a vaccine for celiac disease, the company's recent presentations at the 2017 International Celiac Disease Symposium (ICDS) in New Delhi, India, were welcome news.
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    The company announced at ICDS 2017 that it has presented data showing the immunologic basis for the early clinical effects of gluten in celiac disease.
    Presented in two poster presentations and an oral presentation, the company says its data show that "early cytokine changes in blood following gluten ingestion could provide the basis for a new diagnostic for celiac disease in patients on a gluten free diet with an uncertain diagnosis," said Robert Anderson, MBChB, Ph.D., Chief Scientific Officer of ImmusanT.
    The company says its results are "significant" because celiac disease sufferers often adopt a gluten-free diet prior to being diagnosed by a doctor. This can cause problems and lead to unreliable or misleading results with current diagnostic tests.
    ImmusanT says that their data demonstrate that early changes in circulating cytokines after a single gluten exposure may offer a clinical way to assess celiac disease activity.
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    Read more at BusinessWire.com


    Jefferson Adams
    Celiac.com 11/13/2017 - ImmusanT, Inc., the company working to develop a therapeutic vaccine to protect HLADQ2.5+ patients with celiac disease against the effects of gluten, presented data that shows a way to tell the difference between celiac disease and non-celiac gluten-sensitive (NCGS) based on cytokine levels.
    Professor Knut Lundin, University of Oslo, presented the data at United European Gastroenterology (UEG) Week 2017.
    The results are important, in part because many people go on a gluten-free diet before they ever get diagnosed with celiac disease. It's hard for doctors to ask these people to start eating gluten again so that they can be properly diagnosed. But that's how it currently works. If there are no anti-gliadin antibodies in your blood, current tests are not accurate.
    These data suggest that it is possible to spot celiac disease through plasma or blood test. Along with easier, more accurate celiac diagnoses, a blood test would be a major breakthrough because "patients would only be required to consume gluten on one occasion and would still achieve accurate results," said Robert Anderson, MBChB, Ph.D., Chief Scientific Officer of ImmusanT.
    The test may also help people who do not have celiac disease, but find symptom relief on a gluten-free diet. For these people, gluten may not be the cause of their symptoms and a gluten-free diet may be totally unnecessary.
    The latest data support the company's approach to "developing a simple blood test for diagnosing celiac disease without the discomfort and inconvenience of current testing methods. This would be the first biomarker for measuring systemic T-cell immunity to gluten," said Leslie Williams, Chief Executive Officer of ImmusanT.
    As development is ongoing, further tests are expected to flesh out the details.
    Source:
    Immusant


    Sandi Star, HHP, CNC, CCMH
    Celiac.com 02/08/2018 - Have you ever considered being tested for a genetic defect called MTHFR? If you have a family history of heart disease or stroke, migraines, trouble getting pregnant or have a child with Autism you might want to consider reading on to learn more. These are just a few of the list of conditions linked to MTHFR mutation. Surprisingly, 60% of our population has this mutation and most do not even know what MTHFR is.
    I recently came up positive myself for MTHFR A1298C. We will talk more about the two common markers in a bit. This changes everything when it comes to choices and is important to have the knowledge when choosing foods and supplementation. It's also important to monitor your folate levels. More to come.
    Interestingly, Untreated celiac disease may be associated with hyperhomocysteinemia caused by a combination of vitamin deficiencies and variants in the MTHFR gene. If you are not healing with a gluten free diet this might be a test to consider. [1]
    So, what is MTHFR?
    The MTHFR gene (methylenetetrahydrofolate reductase) is an enzyme that plays an important role in processing amino acids, the building blocks of proteins. Now you know why it's an acronym! Methylenetetrahydrofolate reductase is important for a chemical reaction involving forms of the vitamin folate (also called vitamin B9). This enzyme converts a molecule called 5,10-methylenetetrahydrofolate to a molecule called 5-methyltetrahydrofolate. This reaction is required for the multistep process that converts the amino acid homocysteine to another amino acid, methionine. The body uses methionine to make proteins and other important compounds. [2]
    Although, there are over fifty known MTHFR variants, two are commonly tested C677T and A1298.
    Some of the key things methylation process is responsible for are:
    Cellular Repair – DNA repair is a collection of processes by which a cell identifies and corrects damage to the DNA molecules that encode its genome (genetic material of an organism). Detoxification and Neurotransmitter Production – The interconversion of amino acids. Healthy Immune System Function – Formation and maturation of red blood cells, white blood cells and platelet production. What's the Difference Between the Two Most Common Types?
    The 677T Variant is associated with heart disease and stroke whereas the 1298C is associated with a variety of chronic illness. Either one however can cause general health problems.
    Homozygous vs Heterozygous
    An organism can be homozygous dominant, if it carries two copies of the same dominant allele (allele - one of two or more alternative forms of a gene that arise by mutation and are found at the same place on a chromosome.), or homozygous recessive, if it carries two copies of the same recessive allele. Heterozygous means that an organism has two different alleles of a gene.
    If you are homozygous (2 abnormal copies) your enzyme efficiency drops to 10% - 20% of normal which can be problematic. A more serious combination is 677T/1298C which has both genetic anomalies.
    If you are having symptoms and can't quite put your finger on it I would suggest getting tested for the MTHFR. That will help your practitioner determine what supplementation best suits your needs. Diet will also be a factor as with MTHFR the body cannot process synthetic folate which is in fortified foods such as cereal, nutritional yeast (can get unfortified), breads, rice, pastas, flour, etc., This explains why I always got a headache after I ate fortified nutritional yeast. I switched to unfortified and I don't have the headaches.
    As mentioned above, there are many chronic conditions linked to MTHFR. Here are a few:
    Alzheimer's Autism Autoimmune Disorders Breast cancer Chronic Fatigue Down's Syndrome Fibromyalgia Heart Disease IBS (irritable bowel syndrome) Infertility in both men and women Mental disorders such as bipolar and schizophrenia Migraines Multiple Sclerosis (MS) Sensitivity to chemicals Stroke The Great Detoxifier
    Glutathione is the body's main antioxidant and detoxifier. What happens with MTHFR mutation is it can make you susceptible to disease by lowering your body's ability to make glutathione. Most people with MTHFR have low glutathione levels. With low glutathione levels, you are more sensitive to toxins and chemicals including heavy metals. The good news is you can supplement glutathione in the correct methyl form and change up your diet. More to come on this. With oxidative stress, we are more likely to have premature aging as well. Another reason to be aware of MTHFR and maintain a healthy high folate diet along with supporting supplementation.
    Testing
    If you have any of the symptoms above or have a family history with MTHFR mutations I highly recommend testing for both C677T and A1298. Testing can be done through a practitioner. You can go to 23andme and order the test or work with your health practitioner. It's inexpensive and well worth it. Also, testing your levels of glutathione and folate would be beneficial so your practitioner knows where your levels are before recommending supplementation.
    Supplementation for MTHFR
    If you are taking a B vitamin, make sure it's methyl-B12, methyl-folate. Taking synthetic forms (folic acid) can be more harmful than good because the body cannot do the conversion. It's essential to make sure that your method delivers the antioxidant efficiently to your cells. One of the B vitamins I recommend from Pure Genomics is their B Complex available on our marketplace.
    Glutathione is also important but hard to absorb so a liposome form is recommended or get one with a precursor called NAC (N-acetyl-cysteine). Glutathione is important for detoxification as mentioned. Here are a few to consider – Liposomal Glutathione by Pure Encapsulations as a liposome form With any supplement, you can have adverse effects so make sure you work with a knowledgeable practitioner.
    Diet and Lifestyle
    Folic Acid vs. Folate
    While folic acid and folate may be marketed interchangeably, as mentioned earlier, their metabolic effects can be quite different, especially for those with the MTHFR mutation. Folate is the bioavailable, natural form of vitamin B9 found in a variety of plant and animal foods. Folic acid, on the other hand while readily utilized by the body is synthetic. Folate is found in supplements and fortified foods such as cereals and might I add nutritional yeast. The body is more adept at using folate and regulates healthy levels by discarding excess folate in urine. With MTHFR folic acid can be problematic so make sure you purge the folic acid rich foods and supplements. For those who love the flavor of nutritional yeast and use it in vegan recipes there are a few companies who make unfortified versions you can get off amazon.
    Daily lifestyle activities such as dry brushing (lymphatic circulation) Epsom salt baths, exercise, sauna's (infrared sauna is amazing) and of course a healthy diet rich in natural forms of folate such as:
    Beans and lentils Leafy green vegetables including raw spinach Asparagus Romaine Lettuce Broccoli Avocado Bright-colored fruits, such as papaya and orange Here are just a few examples of some folate rich foods. As you can see spinach packs a powerful punch of folate as well as papaya and lentils coming in the highest. [2]
    Source
     
    Spinach
    Asparagus
    Papaya
    Orange
    Lentils
    Pinto Beans
    Sunflower Seeds
    Serving Size
     
    1 Cup
    1 Cup
    1 papaya
    1 orange
    1 Cup
    1 Cup
    ¼ Cup
     
    Folate
     
    263 mcg
    262 mcg
    115 mcg
    40 mcg
    358 mcg
    294 mcg
    82 mcg
    DV %
     
    65%
    64%
    29%
    10%
    90%
    74%
    21%
    Did you know your liver needs glutathione to produce bile in addition to the detoxification process? Look at addressing health issues such as leaky gut, IBS and Inflammation as these can affect absorption and neurotransmitter levels as well as hormones with MTHFR A1298C mutations.
    MTHFR mutations are tied to higher mental disorders such as anxiety, depression, bipolar and schizophrenia as well as chronic fatigue and fibromyalgia. It's important to find ways to manage the stressors in addition to healing the gut as symptoms can be heightened with MTHFR.
    Protect the heart with an anti-inflammatory diet rich in omegas, fiber and plants. Omega 3 and COQ10 supplementation is helpful. A good multi is beneficial as long as you get one with B12 (methyl cobalamin) and Folate (methyl tetrahydrofolate) forms.
    Drug Interactions to consider
    You should not use any supplements without first talking to your health care provider. For example, folate should not be taken at the same time as the antibiotic tetracycline because it interferes with the absorption and effectiveness of this medication. Folate is necessary if taking medications for birth control, cholesterol or seizures for example as they may lower folic acid levels in the body. Dosage and timing is important to know.
    Here are some medications to keep in mind:
    Antacids, H2 blockers, proton pump inhibitors Bile acid sequestrants Carbamazepine Nonsteroidal anti-inflammatory drugs (NSAIDs) Sulfasalazine Triamterene When taken for long periods of time, these medications, as well as other anti-inflammatory and anti-seizure medicines, can increase the body's need for folic acid.
    Also consider drugs used for cancer, rheumatoid arthritis and psoriasis as those also reduce the folic acid in the body. Supplementing folic acid can help reduce symptoms of these disorders however with cancer, folic acid may interfere with methotrexates effects on treatment. Talk with your practitioner if you are taking any medications. [3]
    Knowing your DNA make up is important as is knowing your numbers (blood pressure, cholesterol, etc.) so you can keep a handle on your health and do your best to control stress. Getting tested for the MTHFR mutation is worth knowing whether it comes up or not. It can make all the difference in aging and detoxing and give you a peace of mind.
    Sources:
    https://draxe.com/mthfr-mutation/  http://doccarnahan.blogspot.com/2013/05/mthfr-gene-mutation-whats-big-deal.html  https://www.jillcarnahan.com/2014/02/23/health-tips-for-anyone-with-a-mthfr-gene-mutation/ 


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