Oral Therapy for Celiac Disease

This press release came across my newswire yesterday. I still have mixed feelings about taking medication to control my celiac disease but I am happy that there is now research going on in our community. 

NORTH CHICAGO, Ill. and SAN CARLOS, Calif., May 14, 2013 /PRNewswire/ -- AbbVie (NYSE: ABBV) and Alvine Pharmaceuticals, a leader in celiac disease therapeutics development, announced today that they have entered into a global collaboration to develop a novel oral treatment for patients with celiac disease, currently in Phase 2 development.  This collaboration builds on AbbVie's expertise and leadership in the field of gastroenterology with its on-market products to treat Crohn's disease, ulcerative colitis, and diseases associated with exocrine pancreatic insufficiency.

ALV003 is an investigational oral therapy composed of two recombinant, gluten specific enzymes (a cysteine protease (EP-B2) and a prolyl endopeptidase (PEP)), that degrade gluten in-vitro and in human clinical testing, and may reduce the symptoms and intestinal injury associated with celiac disease in patients attempting to adhere to a gluten-free diet.  Data from a Phase 2a study reported at Digestive Disease Week (DDW) 2012, showed reduction of intestinal inflammation in patients exposed to gluten and treated with ALV003 compared to patients treated with placebo.

"Celiac disease is an area with significant unmet medical need," said Scott Brun, M.D., vice president, pharmaceutical development, AbbVie.  "Patients who currently are unable to completely avoid gluten in their diets could potentially benefit from this promising investigational treatment. AbbVie has significant experience within immunology and gastroenterology and the exclusive option to acquire this asset complements AbbVie's broad mid-stage pipeline."

"A collaboration between Alvine and AbbVie combines our respective strengths and expertise in the development of what could become the first therapeutic option for this major unmet medical need," said Abhay Joshi, Ph.D., president and chief executive officer, Alvine.  "We are pleased to have an industry leader in gastroenterology as a collaborator, whose considerable global development reach can be focused on getting this novel therapy to more patients."

Under the terms of the agreement, AbbVie will make an initial upfront payment of $70 million for an exclusive option to either acquire the assets relating to ALV003, or the equity of the company. Alvine will maintain responsibility for Phase 2 clinical development, and upon successful completion of the approximately 500 patient Phase 2b study, AbbVie may exercise its option for the agreed upon additional consideration.  Alvine will also be entitled to receive a milestone payment upon AbbVie's initiation of Phase 3 development.  In collaboration with AbbVie Biotech Ventures, Inc., a subsidiary of AbbVie dedicated to making early investments in emerging biotech and pharmaceutical companies, AbbVie was an early investor in Alvine Pharmaceuticals.

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About Alvine Pharmaceuticals 

Alvine Pharmaceuticals, Inc. is a private, clinical-stage, specialty biopharmaceutical company located in San Carlos, CA, focused on the development of biologics targeting autoimmune and inflammatory diseases, including celiac disease.  Alvine is focusing clinical development efforts on ALV003, an investigational drug in Phase 2 trials that could potentially be the first approved therapeutic treatment for patients with celiac disease.  For additional information about the company, please visit http://www.alvinepharma.com.

AbbVie Forward-Looking Statements

Some statements in this news release may be forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995.  The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements.  AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements.  Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry.  Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," in our 2012 Annual Report on Form 10-K/A, which has been filed with the Securities and Exchange Commission.  AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

About AbbVie

AbbVie is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott.  The company's mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world's most complex and serious diseases.  In 2013, AbbVie employs approximately 21,000 people worldwide and markets medicines in more than 170 countries.  For further information on the company and its people, portfolio and commitments, please visitwww.abbvie.com.  Follow @abbvie on Twitter or view careers on our Facebook or LinkedInpage.

Elimination Experiment: Almond Meal Pancakes

I got the go ahead to add eggs back into my diet on Friday. This made me very happy. The one thing I really feel that is lacking during this elimination diet is protein. Actually, I always feel like I should have more protein in my diet. Anyway, with the green light for eggs I decided to make some almond meal pancakes both days this weekend.

On Saturday, I made pancakes using this low-carb recipe minus the sweetener. They were good although I was missing that pancake syrup big time! On Sunday, I decided to change it up a little bit. I wanted more flavor so I put my own spin on these Paleo Pumpkin Pancakes. I basically took the first recipe and added pumpkin puree and pumpkin pie spice instead of all of the individual spices. Although I didn't get the ingredients quite right and the pancakes fell apart a little bit, I liked these much better than Saturday's batch. They had more flavor, which is what I was looking for.

Although I miss my sugary maple syrup, it is nice to know I can once again have a weekend breakfast favorite like pancakes.

Food Frustrations

I am on day 12 of my elimination diet and I am frustrated. You see, I love food. I write this blog about living a lifestyle that revolves around particular food choices. I run a Meetup group that encourages others to not be afraid to socialize (many times with food) outside of the home. I enjoy meeting up with friends for a bite to eat and to catch up. But over the past 12 days, food has become a nuisance. Planning a meal is a chore, not something that I enjoy doing anymore. I get annoyed in the kitchen when I have to spend so much time thinking about what I am going to eat and not just grab something and go.

On this elimination diet, I feel very restricted. I realize how much I love fruit and how often I eat eggs. These are two big no-nos on this elimination diet. I also realize that sugar is in damn near everything. I know there are still a ton of things I CAN eat, but for some reason I cannot get over what I CANNOT eat. For me, this is the first major elimination diet of my life. I was diagnosed with Celiac when I was only 2.5 years old, so I don't remember what it is like to cut out gluten. In my mind, I just always ate gluten-free. This is different and this is hard. Really hard.

Last night, I hosted an awesome NYC Celiac Meetup event at S'MAC. This is one of my favorite gluten-free places to eat in New York City. Who doesn't like gluten-free mac-n-cheese? I sat there chit-chatting with the group members but I was not eating anything. Everyone else was devouring their gluten-free dinner and I was just talking and getting more and more hungry and a worse headache by the minute. It wasn't fun at all. I met great people but I was so annoyed that I couldn't kick back and enjoy the food that they were eating right next to me.

I know I need to eat more on this elimination diet and that I am not eating nearly enough. This is obvious to me, my daily headaches are proof. But with such a busy weekday schedule and a lack of ideas, I just eat what I can. This is not good enough. If I was home all day every day, perhaps I could make a meal plan and spend more time actually planning ahead but I do not have this luxury. I am actually somewhat jealous of these stay-at-home bloggers who make these elaborate meal plans for each week and then cook those meals. Or these people in New York City that spend a quarter of their weekly paycheck to get fresh meals delivered to their homes each day. I know I CAN cook these meals but I just don't have the time nor can I justify paying that much money for someone to do what I know I can do myself.

I called this blog Gluten-Free Fun for a reason. I really do love living a healthy, gluten-free life and having fun while doing it. So this elimination is putting a temporary kink in my fun for the time being and I need to deal with it. End of story.

Ok, I am done venting for today. Thanks for bearing with me, dear readers! 

Free Guide to Gluten Free Living

I got this email last night and I was excited to share the link with my readers. This guide is so great. Be sure to download and save today! 

Celebrate National Celiac Awareness month with your free interactive Guide to Gluten-Free Living.   Click here:  http://deliciousliving.com/gluten-free/guide-gluten-free-living-0. GIG created this Guide in partnership with Delicious Livingto provide terrific recipes, kitchen wisdom, health information and shopping tips. All designed to make gluten-free living more healthy and delicious than ever.

Brain Fog

Foggy brain day

This picture is a pretty close representation of what my brain was like coming to work in New York City last week. Foggy. Thick. Not clear. Yeah, I had some pretty bad brain fog last week. I could't form complete sentences, I was forgetting what I was doing, and I was so exhausted. While I think a lot of it had to do with changing my diet so dramatically for this elimination diet, I also think it had to do with a new "gluten-free" food I put into my mouth.

Last week, I introduced Trader Joe's gluten-free oats into my diet. I had those GF oats in cookies a few times over the past year. I only got sick the very first time but after that I had no noticeable side effects from eating the oats. As a Celiac diagnosed in the 1980s, I was always told to avoid oats. So for more than 25 years, I avoided oats. I did try some crackers and cookies made from certified GF oat flour over the past few years, but I always got sick. I decided I needed something for breakfast each morning and after checking on my elimination diet worksheet, oats seemed to be allowed. I took the plunge and I tried a bowl for dinner one night. I did this at night in case I got "glutened" and needed to be home (aka, near the toilet!) I had no tell-tale signs of my "glutening". No stomach ache, no throwing up, no bathroom runs. I figured I was in the clear. I had oats 3 more times last week and still no regular gluten reaction. But I was foggy, oh so foggy.

I went to the chiro on Friday for my weekly exam. (He is the doctor working with me on this elimination diet.) I told him about my fogginess and he said it might be the sugar withdrawal. He put me on some additional supplements to help me work through the major changes going on in my body. He told me to drink more water, which I think is impossible since I already drink tons each day, and to increase my protein. I left there feeling frustrated and even more foggy.

That night, I thought maybe the gluten-free oats were causing this fogginess. Brain fog is a very real symptom of ingesting gluten and it occurred to me that the oats were the culprit. I actually had a really bad bought of brain fog after my last glutening. I decided that I have lived 30 years without oats in my diet so what is another 30 more without oats. Right there and then I put the oats in the back of the cabinet and decided no more oats.

I have now been GF oat free since Friday and you know what? No more fog! Seriously, I have been more alert and able to remember so much more in the past three days. It is interesting to me that I now have a new symptom to be aware of in case of possible gluten ingesting. I definitely wasn't aware of this symptom in the past but now I know that  this is how my body might react to eating gluten.* I am ok with no oats, especially when I feel like this instead:

Clear brain day

* I did use Trader Joe's gluten-free oats during this experiment. I am not saying these oats have gluten, I am just saying that my experience with ingesting them left me with similiar symptoms as when I eat gluten. By no means does my reaction mean you will have the same reaction. I just want to share my experience with  my readers.

Rudi’s Gluten-Free Bakery Awards 10 Gluten-Free Camp Scholarships

I am so excited about this announcement and slightly jealous. I've said it before and I will say it again, I LOVE CAMP! I think every child should go to camp at least twice in their life. Twice, because if they are like my sister and I your kid might hate their first time. ha! My camp summers were my best summers. I went to sleep-away for seven summers and was gluten-free every single summer! More than 15 years later I still keep in touch with friends from camp. Read on to learn about an exciting scholarship opportunity from Rudi's Gluten-Free.

Rudi’s Gluten-Free Bakery Celebrates National Celiac Awareness Month by Awarding 10 Gluten-Free Summer Camp Scholarships

Rudi’s Gluten-Free now accepting entries to the Gluten-Free ‘Happy Camper’ essay contest on Facebook 

Boulder, Colo. – (May 1, 2013) –Rudi’s Gluten-Free Bakery® is ready for summer vacation and can’t wait to help kids across the country enjoy their summer camp experience, even if they eat gluten-free. According to the American Camp Association, 10 million kids attend a summer camp every year. Since it’s a part of so many kids’ summer vacations, Rudi’s Gluten-Free is inviting Facebook fans to visit the “Rudi’s Gluten-Free Happy Camper” application this May, National Celiac Awareness Month, to submit a 200-word essay from their child for a chance to win one of 10 scholarships to a gluten-free summer camp.

“Enthusiastically giving back to our communities has long been an important part of our business, and this is the third year we’ve made a commitment to the gluten-free community during Celiac Awareness Month,” said Doug Radi, senior vice president of marketing and sales for Rudi’s Organic Bakery. “Summer camp is all about making memories that last, and a child’s dietary restrictions shouldn’t prevent them from having the experience of a lifetime. We’re thrilled that the Rudi’s Gluten-Free Happy Camper program will provide 10 deserving kids with a gluten-free camp experience.”

Parents with eligible children, ages 8-17, can enter the contest by ‘liking’ Rudi’s Gluten-Free on Facebook and submitting an essay from their child explaining what going to a gluten-free summer camp would mean to them. As an additional incentive to enter in early May, Rudi’s Gluten-Free has promised to give the first 250 eligible fans that enter an official Rudi’s Gluten-Free Happy Camper water bottle. The 10 winners will be selected by Rudi’s Gluten-Free Bakery and announced on Facebook on June 10, 2013, giving parents and campers time to plan and pack up for a summertime camp adventure.

"Having a special dietary need like celiac disease can make the simple act of going to camp far more challenging,” said Alice Bast, founder and president, National Foundation for Celiac Awareness (NFCA). “Fortunately, there are more options today than ever before, whether it’s a dedicated gluten-free summer camp or a ‘mainstream’ camp that has been properly trained to serve gluten-free campers. Rudi's Gluten-Free Bakery has done an excellent job supporting the gluten-free community, and we are glad to see them continuing that work with their camp scholarship program."

In the spirit of summer camps, National Foundation for Celiac Awareness (NFCA) also offers a gluten-free training program called GREAT Schools, Colleges and Camps. The online course will prepare camp directors and kitchen staff to safely accommodate your child's gluten-free dietary needs. Learn more at CeliacCentral.org/GREAT/schools. 

Rudi’s Gluten-Free strives to create partnerships and programs that give back to the gluten-free community in a way that drives toward a better, brighter future. Offering gluten-free summer camp scholarships provides the perfect opportunity for kids to be kids without worrying about dietary restrictions. Parents can rest assured knowing that many camps are either entirely free of gluten or cater to gluten-free diets.

In addition to connecting with gluten-free fans for summer camp fun, Rudi’s Gluten-Free recently reintroduced its line of Sandwich Breads with a new Soft & Fluffy recipe. With a yummy taste, longer shelf life, double the fiber content with 2g per serving and the Gluten Free Certification Organization (GFCO) recognizable seal, these breads are the perfect base to a delicious sandwich while camping or hiking this summer. Rudi’s Gluten-Free Sandwich Breads come in Original, Multigrain, and Cinnamon Raisin varieties. 

For more information on the Happy Camper contest and Rudi’s Gluten-Free, visit rudisglutenfree.com.

About Rudi’s Organic Bakery, Inc.

Rudi’s Organic Bakery, Inc., has been passionate about baking better breads for families for more than 35 years. Founded and headquartered in Boulder, Colo., Rudi’s Organic Bakery is the only nationally available brand offering a full line of nutritious and delicious, certified organic breads and baked goods. Rudi’s Organic is committed to baking breads using only the best organic ingredients and no artificial additives, preservatives and GMOs. In 2010, Rudi’s Organic leveraged this heritage to create Rudi’s Gluten-Free Bakery, a line of gluten-free breads and baked goods made with wholesome, all-natural ingredients so that each bite tastes like the real thing. Rudi’s Organic and Rudi’s Gluten-Free products are available nationally at natural foods stores and select mainstream supermarkets. For more information, visit rudisbakery.com.

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2013 Celiac Awareness Month with the NFCA

All month the amazing staff at the National Foundation for Celiac Awareness are working hard to help spread awareness about Celiac Disease. They have a very busy schedule of events including webinars, Twitter chats, giveaways, fundraisers, and more. The NFCA is also featuring gluten-free bloggers on their site throughout the month of may and I am honored to share my gluten-free story with them and you during the month.

In order to keep track of all of the awesome events, I encourage you to download their free Celiac Awareness Toolkit today! 

Happy Celiac Awareness Month

I want to wish you all a very happy Celiac Awareness Month. Use this month to educate others about Celiac Disease. It is your month to embrace your diagnosis and encourage others to do the same. We need to talk about Celiac, not shy away from it! I truly believe the misdiagnosis of Celiac is due to lack of education. Who better to educate than us living with Celiac!? You are not alone in this disease. There is an amazing community of people in this country who know exactly what you are going through living with Celiac. Don't believe me? Just search Google for Celiac, visit Facebook, or jump on Twitter. We will vent with you, cry with you, and this month... Celebrate with you! While you may be one in a million, those with Celiac are 1 in 100! Spread the Celiac cheer!

Day 2-4: Sugar is Everywhere... and Headaches

I admit, after being gluten-free for more than 32 years I have gotten lazy with my label reading. I stick with foods I know and trust. I eat more whole foods than packaged foods and only read labels when I am unsure of a new product or if I see that something on the packaging has changed. With this elimination diet, I have become hyper vigilant in reading labels again. And you know what?? Sugar is in EVERYTHING!!!

Seriously, I am shocked where I am finding sugar. I guess I never really thought about sugar that much until now. I don't live under a rock, so obviously I know sugar is ridiculously prevalent in most diets but the way it sneaks in is just crazy. I think I was most shocked to see sugar in sausage. Mild, Italian, breakfast, "healthy", it doesn't matter. Sugar or a derivative is literally in every sausage package I picked up (and then put down) this week. 

I think the hardest thing for me this week so far has been eating no fruit or eggs. I make fruit smoothies every morning but not during this elimination diet. It's been hard to have fruitless smoothies. Straight up kale and almond milk just doesn't taste the same without a banana and some berries. As for the eggs, I don't think I get enough protein even when not on this diet. Eggs are usually a go-to source of protein for me. I usually boil up a few at the beginning of the week and snack on them during the day. Without these eggs, I have begun to rely heavily on nuts. I do not eat that many nuts, but I am loading up on almonds, walnuts, and cashews. I also bought sunflower seeds which I haven't had in years. I was actually worrying tonight that I having too much almond products: milk, meal, almonds, and butter. I have heard of people developing allergies from eating too much of one thing so I am hoping this really doesn't happen to me.

My main issue since I started this on Friday has been awful headaches. I don't know if it is that I am not eating enough or it is a side effect of the sugar leaving my system, but I've had a headache 3 out of 4 days. I don't usually get headaches this bad so I am assuming it is related to this elimination.

To be honest, I think I could/should cut out even more. I have been eating carrots which are ok according to my doctor. He just doesn't want me eating them all the time and drinking tons of carrot juice. I also feel I am heavy on the nuts, as I said before.

Oh and who decides to go away from home (and their own kitchen) the very first weekend of their elimination diet? Me, of course. I went to babysit my nieces and nephew and went armed with a bunch of food. I was really hungry on Saturday and not as bad on Sunday but did get another huge headache. I probably should have planned ahead a little bit better and brought some additional food with me. It wasn't too bad, but it could have been better.

Let's see how the rest of this week goes. I have dinner plans and a brunch. I think the socializing and dining part of this week is going to be tough.

Thank you for your emails and support so far!

Day 1: Elimination Diet Worries and Woes

Today is the first day of my new elimination diet. Under guidance of my chiropractor, I am starting a three-week anti-yeast, fungus, and mold diet. Ever since the toxic mold in my old apartment in 2011, I haven't been quite right. Although not constantly in pain, I do feel like I am sick 4 or 5 days out of the week. I still go about my life, but I am not ever feeling 100% and haven't been for a long time. I have been to so many doctors, had so many tests, and took so many pills that I pretty much gave up on traditional medicine around December. I started seeing this chiro at the beginning of the year and besides the molds (which are still in my system according to blood work) my chiropractor says my adrenals, stomach, and gut are all in need of help. Since everything is connected within your body, I think he has finally convinced me that I need to do something to get my body in check. I am not a total believer of these alternative medicines yet, but we will see how I feel in a month. Whether or not I believe what my chiro is telling me, he listens to me. This is more than I can say about most of the doctors I have seen in the past year.

I just turned 35 and I use a nebulizer breathing treatment twice a day. I feel like a damn old lady on oxygen. I travel frequently so try explaining why a healthy-looking young female has this machine with wires and switches and 20-40 viles of medication in her carry-on bag. It always makes for an interesting conversation, to say the least. I am on PPI (proton pump inhibitors) for acid reflux but I have no traditional reflux symptoms like heartburn. My ENT said it was silent reflux which manifests itself in me as asthma symptoms and constant hoarseness in my throat. The dosage of PPI I was on in the beginning had me lose 9 lbs in 10 weeks. Everyone always says they want to lose ten pounds, but for someone that has pretty much been the same weight since college this was alarming. Basically, I want to get off the PPIs and treat the cause not the symptoms anymore. The doctor reduced my dosage but I am still on the PPIs and don't want to be anymore.

In comes the new diet as suggested by my doctor. I was diagnosed with Celiac as a toddler so I don't remember making the switch to gluten-free. My parents obviously prepared my food so I didn't have to do anything but eat the safe foods they gave me. This is the first time EVER that I have to seriously eliminate anything from my diet. I did make some changes when I went on the acid reflux medication (no caffeine, chocolate, onions, peppers, tomatoes, and any other triggers) but this new diet seems HUGE to me. I love sweets. As a blogger, I am sent samples all of the time and I eat those samples and then some. I travel and love seeking out new gluten-free bakeries in the cities I am in. I love chips and snacks and if I didn't go to the gym 3 or 4 times a week, I think I would be "as fat as a house" as my grandma Peggy would always say about her sweet tooth as well.

Today is Day 1 of the anti-yeast, fungus, mold diet. This means meats/fowl/fish, veggies, limited grains,  legumes, some nuts, and seeds are allowed. This means absolutely no sugar in any form, no fruit, no dairy, no alcohol, no fermented foods, processed meats, yeast, and snack foods are allowed. The fruit is going to be the hardest, I think. That and sugar is in EVERYTHING! Don't believe me, read the ingredients of your packaged gluten-free food. Where there is no gluten, there is sugar and lots of it. Sugar in mayonnaise. I had no idea! I am also taking some supplements on direction of my doctor as well as my normal medications (for now), vitamins, and a pro-biotic.

Last night, I gorged myself on nachos for dinner with not one but two desserts. I went to bed feeling overfull and not great. I cleaned out my cupboards to remove anything that might be tempting as well as isolated things in my fridge and freezer that I cannot eat. I am such a snacker that I physically had to move snacks to a place I wouldn't just mindlessly reach for them when I was hungry or bored. This is what I needed to do for me and might seem extreme but it is the only way I think I can control myself.

I want to use this blog to vent, hold me accountable, and share my progress with my readers. But I also need your help. I want you to share your recipes, favorite websites, and tips with me. I need your support to go through this. I know so many of you have gone gluten-free as adults so you have already made this major life change. Remember, I was a child and have no recollection of changing my diet. I think I nee to make a meal plan for the first time in my life and figure out what I am going to eat days in advance. This freaks me out a bit.

It is now 10am and I haven't had any food to eat yet today. My normal morning starts with a huge bowl of gluten-free cereal and a fruit smoothie. I am at a loss on how to start this but know I should eat something. The idea of eating chicken for breakfast just seems too weird to me. Ugh. ok. here I go...