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  • Kelly Carter
    Kelly Carter

    A Participant's Perspective on the Failure of the Nexvax2 "Celiac Disease Vaccine" Clinical Trial

    Reviewed and edited by a celiac disease expert.

    Journal of Gluten Sensitivity Summer 2019 Issue

    A Participant's Perspective on the Failure of the Nexvax2
    Caption: Syringe and Vaccine. Image: CC BY 2.0--NIAID

    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 was drinking a nasty gluten drink with the equivalent of 2 slices of bread and to evaluate your reaction and confirm that it was violent enough.



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    The second phase involved updosing. We had to go to the center twice a week for six weeks to receive dose increase injections of the medicine. (I'm going to refer to the test drug as medicine - I don't know if I got Nexvax2 or placebo, but it's just easier to say medicine.) During this phase, I did experience some side effects. Occasionally I would be exceptionally tired or have an upset stomach. It was not bad and nothing that couldn't be managed with a nap and acetaminophen.

    The third phase was maintenance dosing. We had 10 weeks of bi-weekly self injections of the full dose of the medicine. The fourth phase was the food challenges. The fifth stage was post study testing.

    Last time I wrote about my experience, I was all the way into self-injections. I was given 20 pre-filled auto-injectors. I was given a schedule and a log to note when and where I injected. All of these shots went into my stomach. My abdomen was divided into 4 quadrants at my belly button - upper right, upper left, lower right, and lower left. I rotated where the shot went into my abdomen. They didn't hurt at all. I also noted the date, time, and whether or not I received the full injection.

    During this time, I never felt better. My energy levels were up. My weight was dropping without even trying. I was sleeping better. I was exercising better. I had normal bowel movements—which I haven't had in over 10 years—long, soft, well-formed just perfect. Dr. Oz would be proud. All of my celiac symptoms went away. It was like I was normal. This was a very, very good time for me.

    At week 6 of the 10 maintenance doses is when the food challenges began. There were three food challenges. In the three challenges, one challenge would be gluten, one challenge would be placebo, and the third would be of their choice, either gluten or placebo. So, I could potentially get gluten twice or a placebo twice.

    For the first challenge they brought out a big white box with my name on it. Inside were three smaller boxes labelled 1, 2, and 3. The smaller boxes contained a shaker bottle, water, and the powder that could be gluten or placebo. If it's gluten, it has the equivalent of two slices of bread. To start the test I had five minutes to consume the drink.

    This part was mentally challenging for me. In the first phase of the study, I knew I was getting gluten. I could prepare. I knew I was going to be sick and was doing this on purpose for science. That I could handle. This time I didn't know whether I was getting gluten or not. It is mentally tough to not know what you are getting.

    What happens if I react? What happens if I don't react? Does that mean this is a placebo? Does that mean I got a placebo instead of the medicine? What if I got the drug and I still react? Am I an outlier? What does that mean for the study? All of these things were going through my head as I was mentally preparing to drink the beverage. I cannot explain how challenging it was to drink that drink with the time pressure, not knowing what would happen.

    The first challenge went well. No reaction. I was a little nauseous but nothing like my first trip down the gluten road. All was well. It would be two weeks until the next challenge.

    Here's where things go a little sideways.

    I had to go to California between the first food challenge and second food challenge to help a relative who was recovering from a stroke. I packed my study medication, got on a flight, and flew out to the West Coast. Getting the auto-injectors through security was easy with my doctor's note, as well as the frozen ice packs needed to keep the Nexvax2 cold. On my first day in California I woke up with pink eye and a terrible cold. Off to urgent care I went for medicine because I can't risk giving my relative pink eye or a cold. I got pink eye medicine and amoxicillin.

    I was in California for about a week and planed to fly home the following Tuesday. I finished the antibiotic on Tuesday, and did my injection on Wednesday, per the protocol. Thursday I did the food challenge.

    This second challenge did not go well.

    I threw up about an hour after drinking the food challenge drink. That stunk. But I will say this. When I drank the gluten drink at the beginning of the study, I was sick for a week. On the couch with extreme exhaustion, gastrointestinal distress, and just general yuckiness. When I woke up on Friday, I didn't feel bad. I felt quite good. The change between feeling bad for a week and being able to bounce back from a glutening was glorious.

    Not all that is good, can stay good. At about 2:45 that afternoon, my left ring finger became exceptionally itchy, red, and started to swell. I was on my way to pick up my kids from school and stopped to buy some Benadryl cream for my finger. As the day progressed, my finger started to swell and continued to be itchy. By 5 that night, the swelling and itchiness had spread to my palm and my right hand was beginning to itch. By 7 that night both of my hands were so swollen I couldn't make a fist. I had been drinking Benadryl like it was wine and it was not making a dent in the itch or the swelling. By 9 that night, my neck started itching. By the time I left for the Emergency Department at 11 that night, my hands were so swollen I couldn't bend my fingers and both my hands and my neck were incredibly itchy.

    After a few hours in the waiting room, I saw the doctor and he said I was having an allergic reaction. He contacted the study doctors confirming that I was having an allergic reaction. They said to make sure I was safe, give me whatever medication was needed, and don't worry about the study. My health and safety came first. I was given IV Benadryl and steroids and sent home.

    One of the reasons someone was not going to be able to be in the study was taking an oral steroid 6 months prior to the first injection. I was lying in the ER four injections from the end of the study realizing that my participation in the study may be over. The ER doctor did not know what could have caused the reaction and wouldn't hazard a guess, but did say that an allergic reaction to amoxicillin could start several days after stopping amoxicillin. I was told to not do any more self-injections until further notice.

    After a few days, the swelling in my hands went down and returned to normal. There doesn't seem to be any long term effects from this episode.

    Over the next few days, the study doctors and the people from ImmusanT talked about my case. They decided for my safety that I should be removed from the study. I felt like my rocket engine propelling me toward a cure just flamed out. But they were right. We don't know why I had a reaction and we could not risk me having another, potentially more severe reaction next time.

    I had to go to the study center to return the four remaining auto-injectors, do final blood testing, and final testing for the study. It was a very sad day for me. I felt like a failure. My body failed and there was nothing I could do about it. I still feel like that study is unfinished and it makes me sad to write my story.

    Reading the notice that the Nexvax2 trial was terminated early was another blow to me. It was even worse knowing how good I felt on the medicine. It was worse knowing that after the food challenge my reaction was totally different than the first gluten challenge. I believed it worked for me. I feel like I failed, not the medicine, by having an allergic reaction. So when they stopped the trial, I felt like a failure again.

    Looking ahead.

    I hope they look at the data and can find something good in it. I hope they are able to see that the daily journal of side effects went to almost zero when I was on the medicine compared to symptoms almost daily before starting the medicine. I hope they can retool the study to maybe not test against such a high gluten dose. I mean since when is cross contamination the gluten equivalent of 2 slices of bread? Normally, if we get glutened, it is a much smaller amount that makes us sick. Heck, the FDA says anything more than 20 parts per million causes damage, so maybe they could test against a smaller amount of gluten. I think that's where I would look if I were the ImmusanT scientists.

    I also have to remember that Nexvax2 is only one of several drugs that are currently in clinical trials for celiac disease. While I hope to see Nexvax2 again, there are other drugs with real potential. I had hoped Nexvax2 was a cure, but I would be temporarily satisfied with something that allowed me not to worry about every single morsel of food I put into my mouth making me sick.

    As a side note, I write a blog and talk about clinical trials all the time. I found a celiac study looking for healthy volunteers. I had several healthy parents of celiac kids asking for more information so they could volunteer to help propel the quest for a cure forward. The idea that these parents are willing to put themselves in a clinical trial in order to help their children has always demonstrated the quiet hope for a cure that I think we all feel.

    I firmly believe the cure for celiac disease will be here in the next 10-15 years. I'm not sure what it may look like but I do know this—each person with celiac disease and has the ability to volunteer for a clinical trial should. It is worth the time and effort and will potentially pay big dividends in the future for all of us. Science can't advance without some of us putting our bodies on the line.

    In closing, my clinical trial ended in March. I believe my body is working better today than it did before the trial and it's now July. My old celiac body is creeping in, but it still isn't as bad as it was before the trial.



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    I live in Australia and am in regular contact with Dr Jason Tye-Din, who looks after the Australian arm of the research team.

    A more dedicated researcher would be hard to find and the fact that the vaccination did not ultimately cure this disease is no reflection on the doctors/researchers involved

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    I was diagnosed with Celiac Disease in 2007. I was hospitalized in 2011, and had major problems getting safe food. One nurse even argued with me concerning whether or not a brand cereal they were trying to feed me was gluten free (it wasn’t). I had to have my husband bring me food from home during my 4 day stay. Then in 2015 I had a same-day surgery, and was required to eat something before they could release me. Except that they didn’t know what to feed me. This time I was at a large, well known university medical center, yet they didn’t know what to feed someone with Celiac Disease. This is beyond unacceptable. My husband is now deceased & I live alone. I need a hip replacement soon, and am terrified that they will feed me something that contains gluten (this will be at the university medical center). I can understand small community hospitals being confused about the gluten free diet, but when university medical centers have problems with it, something is seriously wrong.

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    I wonder if any of the other participants had any of the same reaction you did. Its entirely possible you had a reaction to nervax, or, amoxicillin and nervax together created the reaction. Whatever the reason I thank you for your participation; you risked your health for the cause; it is apparent nervax was problematic. I hope they are able to review their data and can make a conclusion  

     

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    After your first line of injections and prior to the gluten "challenge" you stated; "During this time, I never felt better".  I wonder if the vaccine can be used to improve the "gut" health of a NCGS or celiac patient while maintaining a gluten-free diet?  

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    3 hours ago, BarbaraDH54 said:

    I was diagnosed with Celiac Disease in 2007. I was hospitalized in 2011, and had major problems getting safe food. One nurse even argued with me concerning whether or not a brand cereal they were trying to feed me was gluten free (it wasn’t). I had to have my husband bring me food from home during my 4 day stay. Then in 2015 I had a same-day surgery, and was required to eat something before they could release me. Except that they didn’t know what to feed me. This time I was at a large, well known university medical center, yet they didn’t know what to feed someone with Celiac Disease. This is beyond unacceptable. My husband is now deceased & I live alone. I need a hip replacement soon, and am terrified that they will feed me something that contains gluten (this will be at the university medical center). I can understand small community hospitals being confused about the gluten free diet, but when university medical centers have problems with it, something is seriously wrong.

    Barbara.  Please discuss this with your doctors.  When my husband went in for surgery, The hospital delivered in a tiny refrigerator in his room so that I could fill it with gluten-free foods that the nurses could give to him if I was away from the hospital.  I also talked to the hospital pharmacist before the surgery and the dietitians.  It turned out they were pretty good about gluten free options, but were horrible about the cafeteria I had to use (outsourced to a different company).  I had them verify every pill, he took as often they use generics which changed during his stay.  Educate staff.  They are usually pretty nice.    Be assertive.  You are the patient and you have rights.  Document.  If you need to, file a complaint/lawsuit.  

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    There is so much talk about wheat gluten sensitivity but, very little conversation about other protiens that might be causing or, adding to someone's sickness. Before I say anymore on that I'll say I have no faith that any grains we consume in America are actually safe anymore. Honestly, I wouldn't even know how to go about being tested for so many other foods allergies. My point is made here by adding, I ate two bowls of "barley" soup the other day & what a mistake that was. The same wheat gluten reaction occured but, worse. My mind was quickly transmitted back to the days as child when I ate Cambell's beef & barley soup. I did not know then the barley in the soup might be causing some of my health issues as a child. One thing peculiar to me is, outside the quick reaction recently from the barley, my reaction to wheat gluten never happens immediately upon eating wheat. It's usually days & up to two weeks later. I have no idea if anyone else reacts this way. However, bare in mind if you will, there's not a day goes by that I'm not sickly in some form or another. I wish I knew how many monsters I'm fighting here. Nevertheless, I always find peace in the understanding that, fasting or greatly reducing all foods for a few days cleanses my gluten sickness considerably & allows me to regain the better part of myself. Perhaps someday I'll list here all my symptons. The list is lengthy & actually, pretty interesting. Even as I write this now, I'm having one of my notorious attacks. It's a blessing to know that Celiac.com is standing with us. Bless you & thank You! RMM. 07/18/2019.

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    On 7/18/2019 at 1:40 AM, Guest PreDestination said:

    There is so much talk about wheat gluten sensitivity but, very little conversation about other protiens that might be causing or, adding to someone's sickness. Before I say anymore on that I'll say I have no faith that any grains we consume in America are actually safe anymore. Honestly, I wouldn't even know how to go about being tested for so many other foods allergies. My point is made here by adding, I ate two bowls of "barley" soup the other day & what a mistake that was. The same wheat gluten reaction occured but, worse. My mind was quickly transmitted back to the days as child when I ate Cambell's beef & barley soup. I did not know then the barley in the soup might be causing some of my health issues as a child. One thing peculiar to me is, outside the quick reaction recently from the barley, my reaction to wheat gluten never happens immediately upon eating wheat. It's usually days & up to two weeks later. I have no idea if anyone else reacts this way. However, bare in mind if you will, there's not a day goes by that I'm not sickly in some form or another. I wish I knew how many monsters I'm fighting here. Nevertheless, I always find peace in the understanding that, fasting or greatly reducing all foods for a few days cleanses my gluten sickness considerably & allows me to regain the better part of myself. Perhaps someday I'll list here all my symptons. The list is lengthy & actually, pretty interesting. Even as I write this now, I'm having one of my notorious attacks. It's a blessing to know that Celiac.com is standing with us. Bless you & thank You! RMM. 07/18/2019.

    Have you been tested for celiac disease? Celiac, an Autoimmune disorder, is triggered by gluten found in wheat, barley and rye.  A wheat allergy or intolerance is just triggered by wheat alone.  

    Learn more about testing:

    https://celiac.org/about-celiac-disease/screening-and-diagnosis/screening/

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    I was diagnosed with Celiac Disease more than 10 years ago.  Your reaction after you took Amoxicillin sounds very similar to what I experienced when on that same drug.  I found out that I am highly allergic to any penicillin type drugs.  Thankfully, there are substitutes I can take.  I'm so sorry you weren't able to finish the trial and that they stopped it.  I pray for the day when researchers come up with something I can take to counteract gluten in my system!

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  • About Me

    Kelly Carter

    I was diagnosed with Celiac in 2012 and have been gluten free ever since.  I live in Atlanta with my husband and two medium sized children.  I run a blog at FatCeliac.net that covers real life issues with celiac disease, upcoming drug trials, and try to be a reliable source of information for the celiac community.


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    Kelly Carter
    Celiac.com 03/22/2019 - I'm going to talk about my journey through the Nexvax2 trial. It is a clinical trial to study the effectiveness of this drug to prevent mucosal damage due to cross contamination. There are 4 phases to this trial - Screening, Updosing, Maintenance, and Post-Study. Each phase has different requirements from the patient and different goals.
    Screening for the Nexvax2 Clinical Trial
    I found out about the Nexvax2 trial from my sister. Her job involves keeping up with medical stocks. She saw that ImmusanT had started their clinical trial - a double, blind, placebo controlled study for an injection to retrain the immune system to stop recognizing gluten as a foreign invader. It works similarly to allergy shots desensitizing the immune system to gluten. I looked up the trial at ClinicalTrials.gov and made a phone call to the nearest location. 
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    I called and talked to Nurse Ratchet (not her real name, to protect the innocent). She explained that it was a long trial, about 7 months, and that I had to be in Nashville twice a week for six weeks. She said she would send me the patient disclosure and she would answer any questions I had when I was ready. She also said that I needed to be able to prove my Celiac diagnosis with both positive blood work and positive endoscopic biopsy. I would have to be on a gluten free diet for 12 months. I would also have to carry the DQ2.5 gene and do a gluten challenge. I will also have to decide if I'm going to participate in the optional endoscopy portion of the trial.
    The twice a week for six weeks thing threw me for a loop. That would be a big time commitment, hard on my family, and very expensive. I wasn't sure we could do this.
    As my husband and I review the disclosure document, there is a lot of information to take in. One of the requirements to get in the trial is having the DQ2.5 gene. I've had genetic testing done several times and knew I had one copy of DQ2.5. In reading the documents, if you have one copy of DQ2.5, you have a 1 in 2 chance of receiving the drug. If you have two copies of DQ2.5, you have a 2 in 3 chance of receiving the drug. Nexvax2 does not work for those with DQ8. According to research, over 90% of people with Celiac have DQ2.5.
    So, I have 50/50 chance of getting the medicine and I have to be in Nashville twice a week for six weeks. That is a big time commitment for a 50/50 chance at the medicine. We decide it isn't worth it. Until, I talk to Nurse Ratchet and she confirms that if I get placebo in the trial, I will get the medicine when the drug is approved. Now we are talking. I have a 100% chance of getting the medicine - either sooner or later. We decide to go for it!!
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    I'm miserable the whole week after the gluten challenge. Fatigue, brain fog, gastrointestinal distress, and just feeling bad is what I dealt with for a week. A full seven days of being completely incapable of living my life in any meaningful way. It was a week of watching TV, ordering food in, and just breathing. Eventually I get better. When the malaise lifts, it lifts like opening a curtain to reveal bright sunshine. I am finally better.
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    We have completed phase 1 - the screening phase. Now, it is time for phase 2 - updosing.
    Updosing: Reaching the Nexvax2 Dosage
    In reading the consent document, updosing is important because when they tried to give people the full dose of the medication in Phase 1 trials the side effects were too dramatic and people dropped out. The main side effects of this medicine are headache, fatigue, and diarrhea.
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    On the first injection day, I had to be in Nashville for for 4 hours so medical personnel can watch you and make sure you don't have an allergic reaction. They use a small insulin needle to inject the drug, so it doesn't hurt. The shot does have to go into your belly, so that's a little weird. I would have preferred it in my arm! The first dose is a very small dose of the medicine with a lot of saline. Over time the amount of medicine increases and saline decreases until about half way through. About half way through the up dosing, you get the medicine straight, no chaser (no saline).
    The updosing is not a challenge. I did have periods where I did experience side effects. Occasionally, I had problems with fatigue and headache, but it did not affect my life or how I functioned. There was one time, specifically, I had an issue with fatigue and headache. This was a bad headache. It did not let up with ibuprofen or acetaminophen alternating every 4 hours. It was about half way through the updosing and it lasted for about 3 days. Then it lifted. Everything was gone and I was back to feeling good.
    Also over the course of this study, I've had periods of flushing. Flushing where my face and neck would turn bright red and feel like they are on fire. When this happens, I would take a Benadryl and go to bed. My mom thinks it is menopause, but that's just for old ladies, not me. The hardest part about updosing was the travel and the grind of going twice a week. I also was doing this in December and January. December and January are hard because of the holiday season, but we also have 3 family birthdays during the span of this period. But we made the best of it and one time the whole family came with me and we spent a couple of days in Nashville.
    Maintenance Dosing
    Once updosing is complete, maintenance dosing starts. Maintenance dosing is 10 weeks of twice weekly injections of the full amount of medicine. They are self-injections. The injections need to stay refrigerated, so I have this super cool cooler in my fridge. TSA didn't even flinch when I came through security!
    I got 20 auto-injectors for the ten weeks of twice weekly injections, alcohol swabs, and a log book. I had to log the date, time, and location of my injection. You inject in a pattern in your abdomen- upper right, lower left, lower right, and finally upper left. I will say this phase was a bit of a relief for me. It meant less travel and just kind of coasting along. Until, the food challenges - duh duh duh daaaaa!
    The food challenges are to see if the medicine is working. There are three food challenges - one gluten, one placebo, and one either gluten or placebo. So, you will get gluten at least once but not more than twice. The challenges are spaced two weeks apart.
    The procedure for the food challenge is much the same as at the initial gluten challenge. They do the normal stuff - weight, blood pressure, and temperature. Then they pull out the big white box with my name on it. Inside the big white box is three smaller white boxes. They all are sealed. These are my food challenge boxes. She takes the first box out and opens it. It contains a shaker bottle, a box of water, and two packets of powder. One packet of powder is flavoring and the other is the test material. She mixes the drink per the instructions and I have 5 minutes to consume this beverage.
    The drink is pink and overly sweet. (At the gluten challenge, there was no flavoring. Just straight up gluten.) The test drink tastes terrible, but I consume the beverage. Then we wait.
    We wait to see if my body reacts the same or differently to the initial gluten challenge at the start of the trial process. It is just a waiting game.
    They said I could keep the shaker bottle we mix my food challenge drinks in. They are really nice shaker bottles. I cannot keep them. I truly never want to see those shaker bottles again. Those shaker bottles are my enemy and I want no part of them. Those shaker bottles make me sick and I don't want them.
    I've done two food challenges to this point. One I had no reaction and the other I reacted. I threw up, but I wasn't tired for a week. I was tired for 24 hours.
    So, that's where we are. We are working through the process.
    I have no idea if I'm getting the medicine or placebo. I don't know if I got gluten at any of the food challenges. That is what makes this so hard. The mental gymnastics of am I getting the medicine or am I not - is very, very challenging. It can consume all of your thoughts if you let it.
    Post Trial
    I haven't gotten to this part yet, I'm still in the food challenges phase of the study. The final part of the study means I will turn in all my used autoinjectors and boxes, log from where and when I did injections, and be turned loose into the world with my new found protections against cross contamination. It will be exciting.
    Conclusion
    I don't know if I got medicine or placebo. I may never know for sure. I have guesses and theories but that is all I have, which makes this really hard mentally. It is hard to have symptoms or not have symptoms and not know if you are getting the medicine. But I think those mental gymnastics are not helpful. I went into this hoping for a cure with the expectation that I would not receive the medicine and would be sick quite often. I haven't been any more sick than I would have been living my life normally, so that's a good thing.
    Some people argue that they never want a medicine for Celiac. They don't want a vaccine or any part of anything from Big Pharma. They say putting gluten in your body is inflammatory and bad for everyone. They say Roundup causes Celiac disease and if you eat organic all will be fine.
    Here's my answer - If you don't want the medicine, don't take the medicine. It isn't required and nobody will force you to take it. But this disease has impacted my life so dramatically, I'm willing to try a new medicine to alleviate the symptoms. This disease has affected my family, my health, my social life, and my ability to vacation among other things.
    Even if this or any other medicine is approved, I'm not sure I would return to a full gluten diet. I don't mind a gluten free diet. I mind the constant vigilance I have to have all the time while eating three meals a day. I mind that many labels are not accurate when they say an item is gluten free, but it has barley or rye in the product. I mind that I can't just take a road trip with my family without carefully planning each meal along the route so that I'm sure I can eat safely. I mind that I have to ask every waiter 15 million questions before ordering at a restaurant in order to get a meal that is safe and even then I'll probably be sick. I mind that I can't engage in normal social activities, like sharing a meal with someone, without doing research on where we can go or just having to bring my own food. I mind not being able to have a scoop of ice cream with my kids at the beach in the summer. I mind a lot of things that this disease has imposed on me.
    I believe most other Celiac sufferers endure the same hardships I do in finding safe foods. So, finding a cure or at least something that makes our lives better is a worthy cause that should be encouraged and cheered. Maybe others don't share my struggles and that is great. Maybe they are happy never going to dinner or out with friends. I'm not. I want a normal life or even some semblance of one where I can do the most basic and ancient ritual of society - sharing a
    meal without fear.
    So, take the medicine or not - it's up to you, but don't knock the people who want it.


    Jefferson Adams
    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 as follows: 
    ImmusanT Discontinues Phase 2 Clinical Trial for Nexvax2® in Patients With Celiac Disease
    CAMBRIDGE, Mass. – June 25, 2019 – ImmusanT, Inc., a clinical stage company leveraging its Epitope-Specific Immuno-Therapy™ (ESIT™) platform to deliver first-in-class peptide-based immunomodulatory vaccine therapies to patients with autoimmune diseases, has discontinued the Phase 2 global study for its lead candidate, Nexvax2®, intended as a treatment for celiac disease.
    Similar to earlier Phase 1 results, Nexvax2 was found to be safe and generally well tolerated. There were no concerning safety issues identified during the study. ImmusanT will be actively investigating data gathered from the trial to further understand this outcome. The company will provide further information once available."
    So, to boil it down: The drug is safe and well tolerated, but it doesn't work any better than a placebo. The company will not pursue further testing.
    That's sad news and an ignoble end for a drug that held such high hopes. Few topics have generated as much excitement among celiac sufferers as the tantalizing possibility of a vaccine. Many eagerly hoped for success, while some wouldn't take it on a bet.
     It's unclear what this means for the technology behind Nexvax 2, as the underlying mechanics for this vaccine, Epitope-Specific Immuno-Therapy (ESIT), were to serve as the platform for future autoimmune treatments.
    Stay tuned for more on this and related stories.


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