PA Vaccine Update

30 replies [Last post]
By B's Mom on Mon, 03-10-03, 20:28

See new info about the vaccine at
[url="http://wcbs880.com/medicine/health_story_069142305.html"]http://wcbs880.com/medicine/health_story_069142305.html[/url]

It looks like it's getting closer to becoming a reality

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By choguy on Mon, 03-10-03, 21:13

I have downloaded the research articles from the website of the New England Journal of Medicine (my company has a subscription). I will begin reading through them and mention anything of interest to the board. The articles will be available in hardcopy when the Journal publishes them on March 13th. I would imagine most large librarys would have it. As one who works for a biopharmaceutical company, I know how data can get people a little too excited. Even if everything went perfectly, this treatment is at least 4-5 years away. But, it is definite progress!

Troy

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By Joanne on Mon, 03-10-03, 21:37

Links to articles published online today in the New England Journal of Medicine

Link for "Factors Associated with the Development of Peanut Allergy in Childhood" by Lack et al.

[url="http://content.nejm.org/cgi/content/abstract/NEJMoa013536v1"]http://content.nejm.org/cgi/content/abstract/NEJMoa013536v1[/url]

Link for "Effect of Anti-IgE Therapy in Patients with Peanut allergy" by Leung, Sampson et al
[url="http://content.nejm.org/cgi/content/abstract/NEJMoa022613v1"]http://content.nejm.org/cgi/content/abstract/NEJMoa022613v1[/url]

Link for "Studying Peanut Anaphylaxis" by Mertz
[url="http://content.nejm.org/cgi/content/abstract/NEJMp030008"]http://content.nejm.org/cgi/content/abstract/NEJMp030008[/url]

Link for an Editorial: "Two Approaches to Peanut Allergy"
[url="http://content.nejm.org/cgi/content/abstract/NEJMe030007v1"]http://content.nejm.org/cgi/content/abstract/NEJMe030007v1[/url]

[This message has been edited by Joanne (edited March 10, 2003).]

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By mchammond on Mon, 03-10-03, 22:02

Thank you for the articles. Maybe eczema and PA have more of a link then once thought.

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By JSaastad on Mon, 03-10-03, 22:20

Thank you Troy very much for reviewing the data and reporting back here, I really appreciate it!!

Jill

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By Beth on Tue, 03-11-03, 17:00

While I am very hopeful about this treatment, the statement about the possible cost of this medication ($10,000 per year) made my jaw drop. Imagine how horrible it would be to know there is such a drug, but not be able to use it due to the cost. You can bet the insurance companies won't be lining up to pay for this. I don't mean to be negative, but the price tag is definitely a huge disappointment. And of course, the fact that no actual release date is in sight.

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By choguy on Tue, 03-11-03, 17:31

I have read all of the associated articles from NEJM about the PA treatment. It is heartening, but one must keep it in perspective. I'm sure many here have read these articles and have your own thoughts, but I will mention a few things that I caught.

1) The study group did not include anybody younger than 12 years of age. In fact, only about 20% of the entire group was less than 17 years old. The immune systems of young children may respond completely differently to this treatment than adults. It may not work as well or there could be more side-effects. Younger children must be included in the next study especially since this is the group most likely to have an accidental exposure.
2)This was a phase II study designed to show efficacy and find a suitable dose. It concerns me that it took almost three years to enroll 82 patients in the study. It could mean people were afraid to go through the peanut challenge or the selection criteria were too stringent. Sometimes in order to get the best results in a study one can make the patient selection criteria very stringent. A phase III study must be done with probably greater than 500 paitients. How long will it take to enroll this many people? The results could be completely different.
3)Subjectivity was introduced in the study when dermining the baseline tolerance. Each study MD had to watch his/her patient during a food challenge and determine the amount of peanut protein that began an allergic reaction. Check the threshold sensitivity ranges: 1-2000 mg! This could skew the outcome quite a bit. A more objective system to determine threshold must be established.
4) As I have reminded several friends already, this is not a cure. This is a potental LIFE-LONG treatment to prevent anaphylaxis from accidental ingestion. As everyone knows, this means a shot every four weeks for life to maintain increased tolerance. It took three shots before most in the sudy reached steady-state levels of the drug. There still was significant protection 8 weeks after the last dose, but it had begun to decline. To be safe, you wouldn't be able to miss any shots. I am sure there are plans to find a better delivery system for the drug, but that could be 10+ years away from the market.
5)I would like to know what happens to the study group after a few years of shots and multiple low-level peanut challenges (cross-contamination levels). Would the dose have to be increased? Is there a dose plateau? Are there more serious side-effects after several years? These are the kinds of things usually answered by a phase III study.

I know it seems like I have thrown "water on the fire" but keep in mind that is what I am trained to do. My research gets torn apart too but that criticism only helps in the long-run. This really is good news: they have shown you can block a peanut-specific antibody by giving another anibody (anti-antibody). The mean tolerance in the study group increased more than 15-fold on average. No more cross contamination worries - maybe [img]http://uumor.pair.com/nutalle2/peanutallergy/wink.gif[/img].

As so often in my field, I am aware of some associated patent issues with this drug (I don't know the details). Every company wants to recoup its hard-earned R&D money from other companies using their technology. Costly court battles could hold-up development of this drug for several years [img]http://uumor.pair.com/nutalle2/peanutallergy/frown.gif[/img] I know that sounds terrible, but believe me, if you saw a competitor using technology you worked on for years (and spent millions on) you would want a piece of the pie too. Lets keep our fingers crossed and hope things work out. I will look forward to seeing the phase III data in a few years. Only then can we be sure on this.

Troy

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By choguy on Tue, 03-11-03, 17:47

I know the price sounds incredibly steep. You are correct - the insurance companies will balk at first. Without going into a lot of detail, $10,000/yr. for this sort of "specialty" product is reasonable. Manufacturing costs are enormous and the patient population is relatively small. Over several years the cost would come down. However, it would be up to all of us to push the insurance companies to pay for the treatment. You would be surprised how quickly things can change once you explain how many ER visits/year could be prevented. I believe some patients have tried lawsuits with some degree of success. If one child were to die (God forbid) that could have been saved if they had access to this drug, the blocking insurance company would probably move pretty quickly to pay for the drug. It has happened before. Also, the marketing drug company has quite a bit of power to sway the insurance companies. If the drug is approved, insurance will cover it - eventually.

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By McKenziesMom on Tue, 03-11-03, 18:15

Thumbs up, Choguy, for your insightful comments about this "cure". It's great to have people on this board that can provide knowledgeable insight on topics that are extremely complex for a layperson such as myself.

The efficacy of this treatment, the cost issues and the long-term effects are significant areas that I'm sure will take years more research.

I think the fact that this even made it to TV just shows that there is a lot more public awareness about peanut allergies and this in itself is a good thing.

Linda

__________________

Linda

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By Beth on Tue, 03-11-03, 18:29

Choguy, I also want to thank you for your comments. What you said about insurance makes sense. I see in your profile that you are a cell biologist. I comment on that because my PA daughter who is in 10th grade has a huge interest in biology and genetics. Hopefully some day she will help with a cure for PA. She is very interested in research, too, so she will be checking out the NEJM, as soon as we can get our hands on it at the library.

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By Love my C on Tue, 03-11-03, 20:26

Qoute from the article:
"Peanut allergies have been rising in recent decades. No one is sure why, but a new study found that baby creams or lotions containing peanut oil may lead to peanut allergies."

I was thinking that these (our) babies were already predisposed to allergies and that eczema was an early indicater of that allergic tendency, not that the creams caused the allergy. They were just bringing relief to our already allergic babies.

But if this theory has been looked into...give me names!!! What lotions and creams have the peanut oil in them?! Let us know so they can be avoided!

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By Chris PeanutAllergy Com on Wed, 03-12-03, 03:35

NEW DRUG CAN BLUNT PEANUT ALLERGIES, TESTS FIND
[url="http://www.safetyalerts.com/articles/03/peanutall.htm"]http://www.safetyalerts.com/articles/03/peanutall.htm[/url]

Read Article

------------------
Stay Safe,

[email]Chris@PeanutAllergy.Com[/email]

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By hannah mom on Wed, 03-12-03, 04:15

Troy
I would also like to thank you for taking the time to post your thoughts about the PA-vaccine studies in such a clear, easy-to-read manner.
Sarah

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By Wilton on Wed, 03-12-03, 05:26

Troy,

Do you have insight into how similar TNX-901 is to Xolair? Today's NYTimes indicated that Tanox, Genentech and Novartis are discussing whether to market a separate PA drug, or get approval for Xolair in treatment of PA. If the products are essentially identical, then I am encouraged by the thought that (1) millions of asthma sufferers will be "testing" the drug before it is approved for PA, (2) it's much easier to find asthma sufferers willing to participate in a study than it is to find PA sufferers willing to be orally challenged, (3) testing of the drug's safety for children will be performed quickly to further tap the asthma market, and (4) research will continue to be well-funded because of the much larger asthma market. As I see it, if the same drug suppresses both PA reactions and asthma attacks, we may have a lot of allies for this and other similar drugs, and may see faster progress than we would if the drug was for PA alone.

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By B's Mom on Wed, 03-12-03, 11:51

Choguy,
Thanks for giving us your professional view on this medical data. I agree with McKenziesMom, that is good to have you on this board to help us cut through all of the medical terminology.
Thanks again!
Helen

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By choguy on Wed, 03-12-03, 15:29

To everyone who thanked me: your most welcome. I'm very glad to be of some help. All of you have far more experience dealing day to day with PA than I. I hope you can help me from time to time with that.

Wilton, from what I have researched Xolair and TNX-901 are similar but NOT identical. As it turns out, Xolair is a competitor to a product my company is developing (they have a 4 year head start on us). Xolair appears to be an antibody to all free IgE antibodies. This includes IgE antibodies produced against peanuts, pollen, dust, pet dander, etc. All IgE antibodies share some common structural components (constant region). Xolair's target is one of those common components. TNX-901 is specific for peanut IgE antibody. Therefore, TNX-901 is what is called a monoclonal antibody - directed against a peanut antibody. The target of TNX-901 is most likely an area on the IgE that binds to peanut protein (variable region). Xolair would probably have some effect on PA but not be as effective as TNX-901. I would imagine having to use a much higher dose of Xolair to get the same results as TNX-901. Those higher doses could have far more sever side-effects. Everyone requires some amount of IgE antibodies in their system to remain healthy. If all of the IgE's are bound by Xolair, one could be more susceptable to infection.

I hope that was clear enough and I did not bog you down too much with terminology. How is Wilton these days? My family lived there back in the late 70's on Drum Hill Road. I have not been back since.

Troy

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By Rae on Wed, 03-12-03, 16:06

Thanks, Troy. I enjoy reading your explainations.

I have not come across anything that has said if there were any symptoms at all when, say, one peanut was eaten. At the risk of sounding dumb, I don't think it would do any good to be able to eat 8 peanuts, instead of less than 1, on an accidental exposure. If you don't know you are eating them, you may not stop until the symptoms are present. Has anyone read anything as to when and what symptoms were recorded?
Thanks,
Rachel

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By Richard on Wed, 03-12-03, 23:23

Rae,

I had the same thought. If you don't know what you're eating, you might keep eating until you have a reaction.

Still, it seems to me that if you can tolerate 6-8 peanuts, the risk of a reaction from airborn allergens, contact with residue and cross-contamination will be very, very low. No more need for peanut-free lunch tables. No more worries about having a piece of chocolate cake or slice of pizza at a birthday party. No more worries about airplanes, movie theaters and baseball parks. And on and on.

Also, the more you can tolerate, the greater the chance you'll be able to taste the peanuts and stop before you reach your threshhold.

Anyone else?

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By Rae on Thu, 03-13-03, 18:49

I totally agree about it helping with the airborn, residue, etc. I guess I need to start praying the insurance covers it since I have 2 PA girls!
Rachel

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By Wilton on Fri, 03-14-03, 02:04

Troy,

Excellent explanation, thanks. Makes sense.

I hope Tanox can continue development of the PA treatment, but according to the NY Times, they have some major legal battles ahead before the drug can progress farther.

Wilton is treating us very well - so far our daughter's schools have been very cooperative, for which we are very appreciative.

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By Liane on Sat, 03-15-03, 15:10

On peanut oil being in lotions etc., I just received this from my mother, who is a pharmacist in Australia (They're doing a lot of news articles on Peanut Allergy over there at the moment, too):

"It suddenly hit me that peanut oil in pharmacy is called Arachis Oil & we used to mix it up in liniments & ointments because it is a "light " oil. I especially remember making up the Methyl Sal. liniment where it is 75%. So when I got to work this am I looked up the Martindale (the pharmacist's bible) & sure as eggs I was right & read all the other things it was used for. The one that scared me was used in drops for softening ear wax eg Cerumol. So that got thrown out when I got home. Think it was 57%. At least they had it on the label. Can be used as an enema & in emollient creams. eg "Eczederm " & "Eczederm with
Hydrocortisone". These aren't Aussie but often the products they give are American or from the UK."

__________________

Rosemary N.

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By Carefulmom on Sat, 03-15-03, 23:12

Troy, the articles I read all said the Tanox drug would also help people`s other food allergies, and also hay fever symptoms not related to food allergies. If this antibody is specific for peanut, that doesn`t make any sense.

About the peanut oil in creams for babies,that study was done by Lack in England. The Los Angeles Times said "The significance of Lack`s results with baby products is less clear. Sampson, who is medical director of the Food Allergy and Anaphylaxis Network, siad the group has been unable to identify any baby products containng peanut oil in U.S. stores" (they are referring to Dr. Hugh Sampson).

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By cooper on Sun, 03-16-03, 02:38

Does anyone else feel that this complicates the issue of when to react to an exposure? Now, for example, we give the epi when there is any known ingestion, but with this new drug, how do we know when to respond? Will my DS be in trouble after two peanuts instead on one? Instead of feeling encouraged, I'm somehow more anxious. Maybe I just don't understand. [img]http://uumor.pair.com/nutalle2/peanutallergy/frown.gif[/img]

__________________

**Allergy Eliminator**

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By choguy on Sun, 03-16-03, 19:18

Careful Mom,
You might want to check to be sure which Tanox drug is being discussed in the article (probably both). Xolair, the non-specific anti-IgE drug will be on the market in a year or less. There is some thought of using that against all alergies - pollen, food - as well as asthma. Because of the legal issues with TNX-901, the company is trying to decide whether to file for Xolair to be used for PA and other food alergies (a way to squeeze more money out of a drug). To the best of my knowledge and my collegues' knowledge, 901 is specific for PA. It was developed for this purpose alone.

Cooper, I think the use of the Epipen would be indicated if you see all of the "usual" symptoms that you would see without the vaccine. The vaccine simply prevents the onset of those symptoms from minimal exposures. Simply put, it increases the amount of peanut protein your child can be exposed to before allergic symptoms begin. Once you pass that threshold, which will be different for everyone (as it is now), you would have to give the Epipen. Hope that explains things. It really allows for a greater margin of safety.

Troy

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By Carefulmom on Sun, 03-16-03, 21:28

Troy, all the articles I read this past week after the presentation at the American Academy of Allergy and Immunology meeting were specifically about Tnx-901. None were about Xolair. It says that Tnx-901 has not been tested for other allergies, but will most likely be helpful. So that makes me think it isn`t specific for peanut. I will email you the story from LATimes.com. There were several others, all after this study was presented on Monday, all about Tnx-901. They all said pretty much the same thing. The others were on paper, so I can`t email them. Let us know what you think.

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By choguy on Mon, 03-17-03, 18:09

CarefulMom, thanks for the articles. Scientific information is not always communicated well be the lay press. However, it did cause me to re-check the scientific literature on 901 and Xolair. You are correct, it appears that I was mistaken about the specificity of 901. It appears to be directed against all IgE antibodies that are typically involved in allergic responses, more especially to food allergies. It is different than Xolair - Xolair binds to a completely different site on the IgE antibody. I apologize for the error to all. I still stand by the statement that 901 should work better against food allergies than Xolair. Xolair really is meant to be a very general IgE blocker. It could have some effectiveness against PA and other food allergies, but would likely require higher doses which may cause other problems. In general, this anti-IgE technology is new and opens up an entire new area of research.

Thank you for alerting me to my error. Like I said, science is all about criticism [img]http://uumor.pair.com/nutalle2/peanutallergy/smile.gif[/img]

Troy

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By ajinnj on Sun, 10-12-03, 22:23

raising for prayforacure

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By MICHELE03142002 on Wed, 10-29-03, 23:15

Anyone have any update on what is going on with any new products to treat or cure peanut allergy? Last year there was so much in the news about Tanox or a vaccine in the near future and now there seems to be nothing even talked about. Also, are the clinical trials for Xolair going to start any time soon? It would be nice to have something positive to focus on (I seem to be having a bad "peanut" day). Thanks.

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By MommaBear on Fri, 02-27-04, 21:26

reraising.

__________________

"Artificial intelligence is no match for natural stupidity."

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By darenberg on Sat, 02-28-04, 02:06

Quote:Originally posted by choguy:
[b]Careful Mom,
To the best of my knowledge and my collegues' knowledge, 901 is specific for PA. It was developed for this purpose alone.[/b]

Troy. I am not sure this is accurate. As I understand the description of TNX-901, it too is just an anti-IgE monoclonal,but is NOT specific for anti-peanut IgE. The fact that so many had improvements in their asthma and other IgE mediated diseases while on TNX certainly suports this notion.

[This message has been edited by darenberg (edited February 28, 2004).]

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By synthia on Thu, 01-13-05, 15:11

bump

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