Trials For Celiac Vaccine Have Begun

[amber]

I was one of the volunteers in this trial for Nexvax2 vaccine. Have recently just finished the trials!

The great news is that with this vaccine given to me by injection, I had NO side affects what so ever.

I hope this is does work out as I would LOVE to get onto this medication and go back to a normal diet again!

Well done in volunteering to do the trial.

That's great that you had no side effects. I know it will take some years if it is successful but despite some negative comments on this topic the majority of celiacs would love be able to be free to eat whatever foods they choose.

No-one is saying that a gluten free diet is not 'normal' but it is restrictive especially when eating out and travelling.

[debmidge]

I was one of the volunteers in this trial for Nexvax2 vaccine. Have recently just finished the trials!

The great news is that with this vaccine given to me by injection, I had NO side affects what so ever.

I hope this is does work out as I would LOVE to get onto this medication and go back to a normal diet again!

Dear Wombat,

What was the injection schedule? Once a week? What foods did you eat during the test period? How did the testers monitor your progress and verify the results?

Your experience sounds interesting.

D.

[Wombat]

Dear Wombat,

What was the injection schedule? Once a week? What foods did you eat during the test period? How did the testers monitor your progress and verify the results?

Your experience sounds interesting.

D.

The trials I volunteered for was to see if any reaction to the Nexvax2 vaccine. It wasn't at this stage to see what happens eating gluten foods after the injection. I suppse the next stage will be to see Nexvax2 vaccine reation to gluten.

I was called into the research hospital (Centre for Clinical Studies) for a day once a week for over 3 weeks, also going in for just blood tests. During the days I was in, I had to fast food, so no breakfast in the morning. I arrived at 6:30am, were I met a few other people volunteering for the same study. First thing we did was asked alot of questions from a nurse to see how we are and making sure we have been on a strict gluten-free diet. After that, we had the usual medical tests (PB, temp, weight, ECG, urine sample, etc etc) and then a blood tests, and wow they took a bit of blood. I was given the vaccine at about 10:30am and was asked to stay in bed and not move much for 2 hours!!! (which also includes going to the restrooms!!) During the 2 hours, the nurses were just coming over every 60 mins and asking how I was, I just repied "I'm fine". I was still food fasting at this time and I was starving!!! We could drink water and thats it. Was getting a little boring, you can only watch so much tv and without feeling bored, Im glad I took my laptop into the hosptial as we are allowed to use them, we are also allowed to use our mobile phones (Cell phones) too!! At about 2:30-3:00pm they did another blood test and asked for another urine sample. At 3:30pm the research hopsital finally gave me a late lunch, I was SO hungry I could of eaten anything!!!

After lunch the nurses did another questionare and asked how I was feeling, again I said "I'm fine", and then finally left the hospital at 4:30pm.

I did this at the hospital 3 times, and with each day visit they were giving me more Nexvax2 vaccine.

Also duning the time they gave me a "diary" which was a question box list with about 10 questions asking how you are feeling etc.

Well this gives you a basic idea how the trials went. I am visiting the hosptial for the last time next Thursday, basically to see if I am ok and letting me know how the testing went and giving me a nice pay cheque!!!

If you have any questions about the trails, I am more than happy to answer them!

Cheers

Wombat (real name is Ty)

[Wombat]

I got mail today from the "Centre for Clinical Studies" where I volunteered for testing out a medication for people like us with Coeliac Disease. In this mail was a press release from "Alvine Pharmaceuticals Inc." which was good news from the trials I was in. Here is what the press release said...

ALVINE PHARMACEUTICALS REPORTS POSITIVE RESULTS WITH ALV003 IN PHASE 1 TRIAL OF THERAPY IN DEVELOPMENT FOR CELIAC DISEASE

Results Underscore Meaningful Advancements Being Made Towards Finding An Effective Pharmaceutical Therapy for Individuals Suffering From Celiac Disease

SAN CARLOS, Caif., October 29,2008 - Alive Pharmaceuticals, Inc., today announced proof of concept in a Phase 1 Trial of ALV003, an oral protease therapy in development to detoxify gluten, intended for use by patients with celiac disease. The trial results confirmed that single doses of up to 1,800 mg of ALV003 were safe and tolerable in healthy volunteers. Doses of the 300 mg level achieved up to a 96% reduction of gluten in a meal in the stomach at 30 minutes, and were will tolerated by patients with celiac disease. In addition, doses as low as 100 mg were shown to be biologically active in degrading gluten in the stomach. Based on these results, Alvine plans to initiate Phase 1/2a multidose trial in early 2009.

"The outcome of the Phase 1 Trial of ALV003 is a major step towards providing people with celiac disease a better quality of life, as there are currently no approved pharmaceutical therapies available", said Dr. Ciaran P. Kelly, Medical Director of the Celiac Center at Beth Israel Deaconess Medial Center and Harvard Medical School.

"Given the difficulty of following a strict gluten free diet, and the potentially serious health consequences of gluten exposure, there is a great medical need for ALV003 and other new therapies targeting celiac disease."

In addition of reporting Phase 1 results today, Alvine presented data in October, 2008 at the United European Gastroenterology Week conference in Vienna, Austria from a study in patients with celiac disease. The study demonstrated that patients with celiac disease who ingested gluten pre-treated with ALV003 showed elimination of peripheral gluten specific reactive T cells as measured by ELISpot responses. The study, conducted at the Alfred Hospital and Burnet Institute in Melbourne, Australia, suggests that a gluten specific ELISpot response may be a useful test for assessing the affectiveness of therapeutics in subjects with celiac disease.

"Results from these studies support the use of ALV003 as a drug to be taken with meals to address unintentional gluten exposure. In addition, the ELISpot study provides evidence that treatment of gluten with ALV003 may result in a reduction in the immune response to gluten in patients with celiac disease," said Dr. Peter H. R. Green, Professor of Clinical Medicine and Director of the Celiac Disease at Columbia University.

"These results provide a strong rationale to advance the clinical development of this compound as a treatment for celiac disease"

About ALV003

ALV004 is an orally administered combination of two proteases engineered to degrade gluten into non-imminotoxic fragments, by targeting the glutamine and proline residues that are common in gluten. ALV003 consists of a glutamine specific cysteine protease (EP-B2) and a proline specific prolyl endopeptidase (PEP).

There is more to that press release, but its about Coeliac Disease and about Alvine Pharmaceuticals.

IF anyone wishes to see a copy of this press release, please PM me a message with your email address, and I'll send it over to you.

Cheers

Ty

[RiceGuy]

Sounds to me that the drug doesn't switch off the immune response. Rather, it's a sort of engineered, targeted enzyme, to be taken with food, to deal with accidental gluten exposure.

So it's sorta akin to how lactaid pills help digest lactose. But most importantly, it does not mean that a person who takes the stuff could go out and have a big mac or a gluten-filled pizza. It doesn't mean returning to the typical American junk food diet.

So it breaks up gluten. Interesting. I wonder what would happen if it was added to wheat dough. Mush? LOL (I'm reminded of how flies barf goop onto their food to break it down, then slurp it up)

[ranger]

I also totally agree with these statements, Momma Goose! Allergy is not the same as an intolerance. I used immunotherapy for my seasonal allergies and had great success with that but Celiac is entirely different. My immune system is wonky enough without introducing a vaccine which claims to allow people to eat whatever they want with no side effects.

The second issue I have with this article is the attitude that Celiacs do not eat normally, as stated by that woman in the article. I have no idea what she eats but I certainly do eat a normal diet. It's a healthy, normal diet also....not the crap that I see people in the US eat on a daily basis. As for more variety, yup, I do that to. I guess it all depends on how much work you are willing to put into one of the most important aspects of a healthy life.....food. All restaurants have gluten-free options too. A piece of pan seared fish or steak plus a baked potato is gluten-free enough for me. Couple that with a good salad and eating gluten-free out is not as hard as some like to think. This disease is as easy or hard as you make it.

Doctors are looking for ways to make money off of Celiac Disease or it's treatment. If they ever do come up with something, whatever form that may take, all of a sudden people will be screened for the smallest amount of acid reflux and put on a pill for life. They will also be (my favorite medical term) monitored, ad nauseum, because this requires regular visits to a medical person. There is no money in celiac disease right now as it only requires adherence to a healthier diet. I'll take that over pills, questionable vaccines and surgery any day!

Dittoe! I eat a varied and delish diet. I eat less bread and more fruits and veges than before, so it's also healthier. My husband also eats gluten free and likes all my gluten-free food. It's not that much more work, but I've always been a from scratch cook.

I also hate taking meds and always prefer a natural solution to medical problems. I can't even fathon taking a pill just so I could eat a peice of bread!