ALV003 Named a Top 10 Inflammatory/Autoimmune Project to Watch

AVL003 has shown promise as a drug to help those with celiac disease cope with the serious problems related to autoimmune and inflammatory issues caused by the disease. This press release shows that this research is getting some attention, which is greatly needed in this field.

Alvine Pharmaceuticals, Inc., a biopharmaceutical company focused on the treatment of autoimmune and gastrointestinal diseases, announced today that the company’s lead therapeutic
product candidate for celiac disease, ALV003, has been selected by Windhover and its advisors as one of “The Top 10 Inflammatory/Autoimmune Projects to Watch in 2012.” This is the second year that ALV003 has been named to the Top 10 list.

Windhover is a leading provider of business information to senior executives in the pharmaceutical, biotechnology and medical device industries. Alvine has been invited to present at Windhover’s Therapeutic Area Partnerships Conference on December 1, 2011 in Boston, MA.

“We are pleased that ALV003 has the rare privilege of being included for a second consecutive year on this prestigious list,” said Abhay Joshi, Ph.D., Alvine’s President and Chief Executive Officer. “The selection, along with our recently announced Phase 2a clinical trial results, validates our belief in the potential value of new therapeutics for use in the treatment of celiac disease.”

Projects are selected by committee based on a rigorous review of the most attractive inflammatory/autoimmune opportunities in the drug industry. The selection criteria include: demonstration of high unmet medical need, large market potential, strong science, multi-level partnering opportunities (biotech and pharma), potential for new opportunities beyond initial indications and corporate stability.

“In the current competitive drug development environment, very few projects rise to the level of being recognized in the top 10 list more than once,” said David Cassak, VP, Content, Windhover Conferences and Elsevier Business Intelligence. “The selection of Alvine’s ALV003 as one of the Top 10 Projects to Watch for a second consecutive year is a highly unusual and exceptional honor.” Alvine recently reported results of a Phase 2a study of ALV003 in well-controlled celiac disease patients that demonstrated for the first time, in a controlled clinical trial, that a drug has the potential to diminish gluten-induced injury in celiac disease patients.

Details of the study can be found on http://www.clinicaltrials.gov

As the trials progress, the future of ALV003 looks good and maybe one day we will have medication that can assist the celiac patient.

Source: http://www.marketwatch.com/story/alvines-alv003-named-a-top-10-inflammatoryautoimmune-project-to-watch-by-windhover-for-a-rare-second-year-2011-11-29


Social Challenges of Celiac Disease

There are many social challenges of celiac disease. It is estimated that 1 in 133 people have celiac disease and 97% of those are undiagnosed. An article from celiac.com last year discussed some of these social challenges and research that is being conducted on the topic:

Anyone who’s tried to maintain a gluten-free diet for celiac disease or other reasons can likely tell stories about the difficulties and challenges they face on a regular basis. Still, very little research has been done regarding the psychological and social challenges faced by people with celiac disease who are attempting to follow a gluten-free diet. Successful treatment of celiac disease requires full compliance with a gluten-free diet. Non-compliance increases risk factors for numerous celiac-associated conditions.

Think about how many social functions center around eating. Almost all of them, holidays, birthdays, business meetings, the list goes on. For someone with celiac disease it makes the function difficult, if not impossible to take part in. The following video explains these challenges from a celiac’s point of view:


Gluten In Medications

A press release today about gluten in medications discusses a a research grant awarded by the FDA for the first scientific research on gluten in medications. Here are some excerpts from the press release.

Ambler, PA, November 16, 2011 –(PR.com)– The National Foundation for Celiac Awareness (NFCA) is proud to announce that the organization has been awarded a $50,000 grant from The Food and Drug Administration (FDA) to fund the first scientific research in the area of gluten in medication.

The project entitled, “Gluten in Medication: Qualifying the extent of exposure to people with celiac disease and identifying a hidden and preventable cause of an adverse drug event,” will characterize the problem of unlabeled gluten in medication and raise awareness of the potential harm that can occur to patients who ingest medications that they do not recognize as containing gluten, a protein found in wheat, barley, rye and their various derivatives.

Although gluten may be included in excipients used in medications, there currently are no regulations requiring drug manufacturers to label the source of excipients used in their prescription or over-the-counter (OTC) medications. To date, there has been no scientific research conducted to determine if the amount of gluten that is in medication results in harm to people with celiac disease or gluten sensitivity, although there are reports of significant patient reactions to gluten in medication.

This critically needed preliminary research aims to validate or nullify the anecdotal adverse experiences associated with gluten in medications that are reported by the celiac and gluten sensitive patient population. Findings from this project will provide a foundation for future investigation within the FDA and scientific communities, through which additional research, labeling, and safe use guideline initiatives can advance.

“This is a major milestone for the celiac disease and gluten sensitive community,” said NFCA President and Founder, Alice Bast. “A central part of NFCA’s mission is improving the quality of life for the diagnosed population. Keeping patients safe is an integral part of this undertaking.”

Research will be underway in November 2011. A national survey distributed to the celiac disease patient population, which will help researchers identify the adverse interactions patients experience and the types of medications that may have caused them, is set to begin in early 2012.

You can access the full press release here:  http://www.benzinga.com/pressreleases/11/11/r2135820/nfca-receives-fda-grant-for-gluten-in-medications-research#ixzz1e5CM21i4

Although the amount of this grant is low for the amount of research needed, the research is long overdue and this is a great step forward in providing information to celiac patients about gluten in medication that impacts their everyday living and quality of life.

Gluten Free Fast Foods

The gluten free diet is becoming ever more popular for a couple of reasons. The diet has caught a following of people that love organic foods and vegan selections but the most popular reason is the new awareness of celiac disease. A gluten free diet is the only treatment available for those diagnosed with celiac disease, which affects an estimated 1 in 133 people worldwide. As reported by Jane Anderson for about.com, more fast food chains are offering gluten free fast foods selections.

The growing popularity of the gluten free diet means even fast food restaurant chains, which tend to have pretty gluten filled menus, are jumping on the bandwagon, providing more options for those of us with celiac disease or gluten intolerance.

Just be careful; the risk of cross contamination in fast food restaurants, even those with gluten-free menus, is extremely high, and it’s unlikely the people behind the counter have been trained in avoiding it. Keep your order simple and your instructions explicit for the best results.

Here is a rundown of common fast food restaurant chains and their gluten free menu options:

1. Wendy’s

Many people with celiac or gluten intolerance head to Wendy’s as their first choice when looking for a gluten-free fast food restaurant. According to Wendy’s published gluten-free menu, most or all of the chain’s trademark baked potatoes are gluten-free, as are Wendy’s chili and chocolate and vanilla Frostys.

At Wendy’s, you can eat the salads without croutons (assuming they’re not pre-prepared with croutons — never, ever pick croutons off a salad!), and most of the salad dressings are listed as gluten-free, as well. You also can order a hamburger or cheeseburger without the bun. In some Wendy’s locations, you may be able to eat the French fries — you’ll need to check to see if they’re fried in the same oil as gluten-containing items.

2. Arby’s

Arby’s, owned by the same company as Wendy’s, also features a fairly comprehensive gluten-free menu for a fast food restaurant. If you’re gluten-free, it’s possible to dine at Arby’s on most of the meats (without a bun, of course) and two meal-sized salads — the farmhouse salad with turkey and ham and the farmhouse salad with roast chicken. The chocolate, jamocha swirl and vanilla shakes also are listed as gluten-free.

However, unlike Wendy’s (and like most other fast food restaurants), Arby’s prepares its fries in the same oil as it cooks gluten foods, so Arby’s fries and potato cakes are not safe.

3. Chick-fil-A

Chick-fil-A provides the best gluten-free list of any fast food restaurant — the six-page document lists a huge variety of menu options and provides the ingredients for each one, so people with additional food allergies or intolerances can determine what’s safe for them to eat. It’s possible to enjoy several different meal-sized salads (with chicken or without), a couple of different breakfast items, and Chick-fil-A’s waffle fries, which are cooked in separate fryers (be sure to check with your individual restaurant to be sure about the fryer status). In addition, Chick-fil-A’s yogurt parfait and Ice Dream dessert cup are listed as gluten-free. Many people report good gluten-free experiences at Chick-fil-A.

4. McDonald’s

McDonald’s doesn’t maintain a gluten-free menu, stating instead that since ingredients and suppliers change frequently, people with concerns should check back at the company’s website. There’s a tremendous debate in the celiac community about whether McDonald’s fries are gluten-free.

5. Burger King

Burger King unveiled its new gluten-sensitive list in early 2010 as part of its “BK Positive Steps” campaign to provide more nutrition information on its menu items.

The Burger King list includes both menu items and ingredients in menu items, and it can be difficult to decipher what on the menu actually will turn out gluten-free — for example, it states that “salad mix” and “lettuce” are gluten-free, but doesn’t say whether a prepared salad would be safe. Still, the list might provide some options for a starving celiac if it was coupled by an understanding Burger King staffer. It might be possible to get a bunless hamburger there.

6. Chipotle Mexican Grill

Chipotle Mexican Grill, which spans the gap between a fast food restaurant chain and a casual dine-in restaurant, offers a huge variety of options for people with celiac disease or gluten intolerance. In fact, everything on Chipotle’s menu except for the flour tortillas is listed as gluten-free on the company’s Special Diet Information handout.

Celiacs who react to distilled vinegar should avoid the red tomatillo salsa, and Chipotle’s notes that anything with corn might have been contaminated by other grains before ever getting to the restaurant (they’ve obviously done their homework!). Otherwise, if you’re lucky enough to have a Chipotle’s nearby, enjoy. Just make sure to ask the people making your food to change their gloves first.

7. Sonic Drive-In

If you like burgers without a bun, you can order one at Sonic Drive In, and the fries and tater tots are gluten-free, too, according to Sonic’s allergen table. However, Sonic’s shakes, which come with a huge variety of toppings, are a better reason to go to the drive-in fast food restaurant. Most of the potential shake toppings are gluten-free (with the exception of obvious ones, such as Oreos and pie crumb pieces).

8. In-N-Out Burger

Devotees of In-N-Out Burger (and there are quite a few in the gluten intolerant community) order their burgers “protein-style,” or wrapped in lettuce instead of in a bun. This is such a popular item (both for the gluten-free and for Atkins devotees) that the fast food restaurant chain has it listed on its secret menu. In addition, the In-N-Out fries should be gluten-free and therefore safe (but never forget to ask).

9. Taco Bell and KFC

Taco Bell maintains a list of problematic ingredients for people with allergies and sensitivities, but sadly, the only gluten-free items on it are limeade sparklers and a handful of sauces. As for KFC, there’s basically nothing safe to eat for celiacs there, and the chain has made no effort to accommodate us.

Source: http://celiacdisease.about.com/od/eatinginrestaurants/tp/More-Fast-Food-Restaurant-Chains-Offering-Gluten-Free-Menu-Items.htm

This is not a complete list of gluten free fast foods but it gives you an idea of what is available. Make sure to do your research before you go so you can make and informed and safe decision on what to eat. As a thanks for reading this post you can get a $100 gift card to your favorite fast food chain here.

 

Practical Suggestions for Celiac Patients

Here are five simple, practical suggestions for celiac patients:

  • DO NOT stop eating gluten until you have gone to the doctor, even if you think you have celiac. This may sound a bit counter-intuitive, but actually, it’s extremely important. The way that the doctor tests for celiac is by checking your blood to see if you’ve developed antibodies to the gluten you’ve been eating. If you stop eating gluten, the doctor probably will not find antibodies in your blood stream, thus impeding his ability to properly diagnose you.
  • Start talking to people who have celiac disease, so that you can learn more about coping strategies, swap stories, and share tips with one another.
  • Log onto the internet – there is a huge wealth of information available to you there. All sorts of practical tips, guides, suggestions etc.
  • Buy a cookbook. There are all sorts of yummy, gluten free recipes available out there. There’s no need for celiac disease to limit you, if anything it should serve as a motivator to expand your current repertoire. So get set up in your kitchen, and let those creative juices flow!
  • Visit your local health food store. They will have gluten free alternatives to some of your favorite foods. For example, gluten free pasta, crackers and cookies, rice or soy crackers, and bread made from soy flour to name a few possibilities. Start looking around and don’t be afraid to try things out. Learn more about which foods you like, and which ones you don’t! Original source: http://annetterozen.hubpages.com/hub/celiac-top-10

There is a lot of information out there and sorting through it can be a daunting task. I like to read people’s personal experiences because most celiac patients are honest about what works for them and what doesn’t. Every celiac patient is different and their body can react in different ways than others. It’s all about finding out what will work for you. Trial and error is what will get you on the right track, just don’t give up!

Gluten Free Bread Machine

A person with celiac disease only has two options when it comes to eating bread; pay outrageous prices for gluten free bread in the grocery store or make your own. My experience with store bought gluten free bread has not been very good. Fresh gluten free bread is just not to be found. Enter the gluten free bread machine! Finding the right gluten free bread machine can take some research but you need to look at it as an investment in your health.

The many advantages to owning your own bread maker

There are a variety of reasons why baking using a bread maker is the chosen method for many people today and we’re going to examine a few of them. Preparing your own bread at home is a superb idea and one that comes with many benefits when making use of a bread machine.

Bread these days can be filled with chemical preservatives and various other ingredients that do not need to be there. Using a bread machine to make your own bread in the home gives you freedom over just what ingredients go into your bread to be sure its nice tasting as well as great for you as well as for your family.

Another benefit is that using a bread machine lets you bake gluten free breads, which are a necessity for celiacs and perfect for those who have lower level gluten intolerance. Utilizing a bread machine enables you to bake using only ingredients that are harmless and healthy for you as well as your household. A perfect example is the Panasonic SD-YD250 Breadmaker.

Together with the health advantages there’s also cost savings for households who go through a lot of bread. While the initial cost of a bread maker may set you back somewhat, it will last you for years and save you a ton of money over buying loaves from the supermarket or bakery.

These days many top line bread machines feature extra options that enable you to do great things such as bake cakes, make pizza dough etc. Quite a few bread machines incorporate several functions above and beyond simply baking plain old bread.

There’s practically nothing quite like a fresh loaf of bread from the bakery, especially very first thing each morning. So consider what it might be like to wake to a home baked loaf every morning, right out of your bread machine, all set for your family to enjoy.

And last, but not least, is the fun factor. Baking bread at home in your favorite bread maker is really a satisfying experience and something that a whole family can enjoy. There’s absolutely nothing quite like trying something completely new, or maybe a twist on a favorite recipe to discover how it turns out. From subidores.com

A gluten free bread machine would not be complete without a gluten free bread recipe. I found this one at my-extraordinary-life.blogspot.com

Dry Ingredients
2 cups Tapioca Starch
1 1/2 cups Brown Rice Flour
1/2 cup Potato Starch
5 Tablespoons Sugar
4 teaspoons Xanthan Gum
2 teaspoons Salt
2 teaspoons Baking Powder

Wet Ingredients
6 egg whites, lightly beaten
1 1/4 cup Warm Water (approximately 110 degrees)
1 teaspoon Vinegar
4 Tablespoons Oil
4 teaspoons Yeast

  • Combine dry ingredients (first 7) and mix well.  Make sure those dry ingredients are fully incorporated.
  • Add yeast in warm water.  Allow sit until it starts to become foamy.
  • Add egg whites into a bowl large enough to beat with a fork.
  • Whip egg whites with a fork for 2-3 minutes or until light and fluffy, ALMOST soft peaks.  We are just looking to break up the egg white jell here, not to foam it up to soft peaks.
  • Add oil and vinegar to egg mixture and place into machine pan with paddles inserted. (first layer)
  • Add yeast/water as next layer. (second layer)
  • Next add the dry ingredients gently over top. (third layer)
  • Set your machine according to the programming up top.
  • Machine will beep once mixing cycle is almost complete.  Take this opportunity to check batter consistency, scrape the batter down with a spatula and remove paddles if necessary.
  • One bread machine beeps to alert you to the baking cycle being complete, take loaf pan immediately out of the machine.
  • Gently tap the side of the pan to loosen the bread and take it out.
  • Cool COMPLETELY on a rack until bread is room temperature.  Dont’ cheat here, it needs to cool.

Notes:
I can’t stress this enough, take the bread immediately out of the pan once it is finished baking in the bread machine.  Otherwise too much moisture will cause the bread to collapse.

Try adding dry powdered milk for the nutritional value (if you can tolerate it).  I have small children with growing bones and added Calcium and Vitamin D would definitely help.

I am using Instant Dry Yeast and I am proofing it first even though manufacturers say you do not have to.  For some reason it works better for me this way.  The non proofed yeast results in a more dense bread.

Dough that is perfect for the bread machine will form a soft peak. Dip a spoon or spatula into the batter and pull gently up.  Dough will just drop over at the very top is the correct softness.

Humidity and where in the world you live has a huge influence on your bread.  Try the recipe first.  If you need improvements or have issues, start by leaving out 2-4 tablespoons of water and look for the correct consistency during the mixing cycle.

If you never made Gluten Free bread before, it will not look like gluten bread.  It will be more dense and sticky and should form soft peaks (like egg whites).

Check out some of these gluten free bread machines to compare features and prices:

I hope you agree with me that a gluten free bread machine is a necessary tool for the celiac following a gluten free diet. Leave a comment below to let me know what you think!