Tanox Vaccine

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Here is a link to an announcement from Tanox about the vaccine. Anyone know what this means?

[url="http://www.prnewswire.com/cgi-bin/micro_stories.pl?ACCT=no&TICK=TNOX&STORY=/www/story/09-24-2002/0001805314&EDATE"]http://www.prnewswire.com/cgi-bin/micro_...001805314&EDATE[/url]

On Sep 24, 2002

My husband works in pharmaceuticals and he says that it means that the FDA found it to be important, so in effect, some of the red tape will be cut and they will be able to proceed with their studies by skipping over certain steps. (I hope I paraphrased him correctly.) Isn't it exciting??!!

On Sep 25, 2002

I don't know anything about the process for FDA approval. Does this mean it could be 7 years instead of 10, or what? How long does this process usually take?

On Sep 25, 2002

Found the following article from the DowJones Newsire..a spokeswoman for Tanox says the drug won't hit the market until 2005 or 2006. Here's the link:

[url="http://biz.yahoo.com/djus/020924/1643000725_1.html"]http://biz.yahoo.com/djus/020924/1643000725_1.html[/url]

On Sep 25, 2002

This is good news. Xolair, the asthma drug which is very similar to the TNX-901 (formerly HU-901) peanut allergy drug, was delayed in its FDA approval process. The FDA, responding to some recent recalls of approved drugs, asked for more testing to be done on Xolair.

There were concerns that this would delay TNX-901. It is still possible that the FDA will take a conservative approach and push TNX-901 back as well, but the Fast Track status helps.

[This message has been edited by Wilton (edited September 25, 2002).]

On Sep 25, 2002

I contacted Dr. Hugh Sampson regarding the fact that we believe the vaccine is geared towards children 12 and older, and what time frame is expected (as of the 9/24 announcement) for this vaccine to hit the market.

Here is his response received today -

"We are doing studies to cover patients from 2 yrs to 60 yrs. The company still estimates 3 - 4 years before final approval.

Hugh A. Sampson, M.D. Professor of Pediatrics & Immunobiology Chief, Pediatric Allergy & Immunology Director, Jaffe Food Allergy Institute"

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

On Sep 26, 2002

I wish he could have been more specific. It is my understanding that initially, it will be approved for children 12 and over - children under 12 would have to wait much longer for it to be approved for them. Maybe I'm wrong. I sure hope I am!

On Sep 26, 2002

In the quote above Dr. Sampson mentions "2 yr to 60 yrs". Although it is only being presently tested in 12 yr olds and up for efficacy (since one would need to injest peanuts in order to prove that it works), it is being presently tested on children for safety and possible side effects. So, once it is approved, doctors will be able to prescribe for anyone. This is so hopeful! Andrea

On Sep 26, 2002

That is wonderful news, Andrea! Where did you get that information?

Thanks, Judy

On Sep 26, 2002

Does anyone with asthma remember when albuterol (same as ventolin) was brand new? It was first approved for age twelve and up, then age six and up, later age two and up. But many physicians were prescribing it for younger children, younger than the approved age level at the time because it was such an effective medication with fewer side effects than the medication before it (which was alupent). So....maybe even when this pa medication is only approved for twelve and up, maybe we will be able to ask our physicians to prescribe it anyhow if our child is younger.

On Sep 26, 2002

I imagine the day when I'm sitting around saying "remember when our son had peanut allergy? Gosh that was a difficult time, wasn't it? So glad we don't have that to deal with anymore".

On Sep 26, 2002

Judy H, I heard it from Amie Rappoport, Administrative Director of the Food Allergy Initiative, who was the guest speaker at our Food Allergy And Asthma Group meeting this month. She spoke of various VERY promising studies that FAI is presently involved in, but I hesitate to post, since I don't have a hard copy or link. They are planning to publish a newsletter, coming out in October, describing the studies that FAI is working on and sponsoring. Andrea

On Sep 26, 2002

Thanks, Andrea. That is terrific.

On Sep 28, 2002

I had contacted Amie Rappoport also and here's the response I received from her today via e-mail -

"This drug is not approved. Phase III, the last of the three phases before the FDA will even consider approving it, has not started yet and I am not certain of the protocol.

I know several of the children who are in a trial where they are given one dose of the drug. They are investigating if there are side-effects of children.

We are very optimistic, but this is just a safe-guard, not a cure. But, fast tracked status is very good and very exciting!

Amie Rappoport Food Allergy Initiative "

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

On Sep 28, 2002

I wrote to Dr. Nancy Chang at Tanox and told her that we in the PA community are wishing her godspeed on TNX-901. I wanted to say "kick some peanut a*&!" but kept it professional. Told her I would rather have a vaccine for PA than win the Texas lottery!

On Sep 30, 2002

hmmmmmmmmmmmmmmmmmmmmmmmmmmmmm About a year and a half ago...........a pulmonary specialist at a very large children's hospital in my area was eager to have my son, an asthmatic with allergies and a severe peanut allergy, (and reactive airway disease subsequent to RSV as an infant) participate in an anti-Ige vaccine which had been studied in Britain. Because my son came to him on very little medication and left on inhaled steroids and puffers, (which just by coincidence made him an IDEAL candidate for the study) and because my child was not in dire need of any additional treatment for his asthma or allergies, (at least in my opinion), we opted not to submit him to the study. It involved injecting substances in his body to supress part of his immune system, specifically, his high IgE level. I'm not a particularly trusting person, especially where big dollars and matching "kudos" for physicians are involved. Not to mention the involvement of pharmaceutical companies. I detected a conflict of interest which involved a physician heading a study recruiting my child who he just coincidentally prescribed for. I could be wrong. This aside, I did not feel it was a particularly safe thing to mess around with, this "repressing IgE" and all................afterall, we are finding out that our immune system is involved with much more than just fighting colds. Now don't get me wrong, I get my children vaccinated and feed them antibiotics when necessary. I even allow steroid medications in their bodies when the need arises. But, only those medications which have survived the "mass clinical trials". In other words, the medications must have been on the open market for several years and adverse effects documented in a large population. Let's say over 2 million people 2-5 years later. I regularly check "Med-Watch", an FDA website, for medication withdrawals and potential problems. You would not believe how many drugs actually get pulled after initial introduction, especially antibiotics. And they get pulled for some pretty scary reasons. Who knows, this drug may turn out to be a miracle cure, or it may not pass muster. A side note here, when I allow my child to be vaccinated, I ALWAYS make sure they have been healthy prior to vaccination, and that the number of vaccines are limited during the visit. I only allow one at a time (and one could be a combo vaccine such as MMR). Just my own thoughts.

On Sep 30, 2002

When I first read the literature on the trials they did on the mice with the vaccine there was a big question mark as to how it would act in the 'real world'. This is because the mice that they injected were bred to carry the gene for reactivity to peanuts ie they wouldn't have had a first reaction to peanuts BEFORE they had the vaccine - now which parent do you know would KNOW that their child is allergic to peanuts until they've had a reaction to it? Maybe this was just the first trial they did and future trials did prove that it was effective for the 'real life scenario'...here's hoping...

On Oct 1, 2002

MammaBear - there was a story on "Dateline NBC" 2 weeks ago about an 18-year-old with a genetic condition which typically kills the person before age 2. His body produced too much ammonia. He was a miracle of medicine, taking all sorts of medications and having a very strict diet. Against his father's wishes, he volunteered for a gene therapy study, which would attach a modified gene to a virus and be injected into his body. To make a long story short, it turns out the doctor had a financial interest in this vaccine, as he owned the company. They put too much virus in his system and his body shut down. He died. All of these improprieties came out well after the fact. The doctor approached the boy's father and asked him to support the program, even though it killed his son. I believe the doctor really wanted to find this "cure", but not at the expense of this boy. All of this was done at the University of Pennsylvania, not a rinky dink hospital.

So, I do not blame you for your decision. That story was so scary; there has to be a way to test new medical tests and vaccines, but it's hard for people to know what the true motivations are.

On Oct 1, 2002

I was reading the Tanox site the other day. It says that the trials involve giving the person one peanut, then another until they react. After receiving the vaccine the process is repeated to see if they can be exposed to more peanuts before they react.

Considering that my daughter will react to just touching the peanut, yet not actually eating it, I wonder how they were able to find people able to participate in the study and if it is reflective of a person with a severe allergy.

Just wondering

deb

On Oct 1, 2002

The treatment is supposed to take the anaphylaxis out of the allergy. Participants are entitled to the treatment free for life.

On Oct 1, 2002

Heather 2, where did you hear that the treatment is supposed to take the anaphylaxis out of the allergy? I`d love to see that in print somewhere. I was wondering the same thing as DebO, since my daughter`s allergist wanted to put her in the study, then didn`t when he found out about the peanut challenge after the vaccine. It makes me think that the study would select out for people who are mild.

On Oct 2, 2002

I have also heard that this will "take the anaphylaxis out of the allergy". This is not a cure, but will hopefully prevent severe reactions due to cross-contamination, contact, inhalation, and all the other every-day situations that could potentially effect a severely allergic person's life.

Now, if a multiple food allergic child was on the Anti-Ige to lessen or prevent accidental exposure to peanuts, how would we know if they had outgrown or become less sensitive to other foods? We are hoping that ds will eventually outgrow his egg, and possibly milk allergy. Would the Cap Rast be able to detect the Ige levels if the Anti-Ige was helping these levels to remain low? How would we know? Andrea

On Oct 3, 2002

The Asthma and Allergy Foundation of America has lectures locally every month. I have attneded so many of those lectures, I couldn't even begin to count them. Here in the Boston area we almost always get a speaker that is affiliated with Children's Hospital, one of the test sites for Tanox's treatments. After each lecture, there is a Q&A session and I try to make it a point to ask about the treatment each time. If I say, "tell me about the progress of the vaccine" they correct me and say it is not a vaccine - it is a treatment which will have to be kept up every month. It is these doctors that have told me it will not make the allergy go away, but just take the life threatening part away. Hey, I'll take what I can get. I'm hoping it will mean we can nix the stupid EpiPens. Or at least not worry about keeping them at the right temperature all the time. Now this is not to say that there is not a vaccine in the works - there is. The company is called Dynavax. I put their web site on here somewhere. It's just that Dynavax is much further behind in the process. Last time I checked, they were still in preclinical phase testing on mice. But their vaccine is supposed to be very promising. Let's keep our fingers crossed for both companies!

On Oct 21, 2002

Yes, the Tanox drug suppresses the reaction, but does not make the allergy go away.

However, (and please view this as speculative - it sounds good on paper but hasn't been tested) it is possible that the Tanox drug can be used as part of a treatment that would actually cure the allergy. Some allergies (like bee sting) can be cured by desensitizing the immune system through progressive exposure. But, as we all know, the PA response is so violent that people die before they can be desensitized.

It is possible that a suppressing drug like the Tanox drug would keep down the reaction, and allow a patient to go through a desensitization regimen. This would effectively "cure" the person.

This is a very poor paraphrase of a couple conversations I've had with allergists and a representative at Tanox. Again, it is only speculative.

On Feb 11, 2003

reraising.

On Mar 11, 2003

reraising.

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