Good news on TNX-901?

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[url="http://phx.corporate-ir.net/phoenix.zhtml?c=120940&p=irol-newsArticle&ID=499325&highlight="]http://phx.corporate-ir.net/phoenix.zhtml?c=120940&p=irol-newsArticle&ID=499325&high light=[/url]

Article states that the three companies have resolved their dispute, but also says that they look forward to developing Xolair as their lead product for peanut allergy.

My take on this is good & bad. Xolair has already been rigorously tested for safety in phase I & II trials for asthma. It shouldn't be long to get phase III trials started for peanut allergy, and the rate limiting factor will be the willingness of patients to step up and volunteer for the studies.

I'd love to hear what Hugh Sampson's take is on this.

[This message has been edited by darenberg (edited February 26, 2004).]

On Feb 26, 2004

At least they are moving forward again. PHEW!

On Feb 26, 2004

I've called around our area and tried to find a trial going on so I could get my son into it. No luck yet. Peg

On Feb 26, 2004

-------------------------------------------------------------------------------- [url="http://www.latimes.com/business/investing/wire/sns-ap-allergy-drug-settlement,1,2726553.story?coll=sns-ap-investing-headlines"]http://www.latimes.com/business/investin...sting-headlines[/url] Biotech Companies Settle Legal Dispute By PAUL ELIAS AP Biotechnology Writer

2:26 PM PST, February 26, 2004

SAN FRANCISCO

On Feb 26, 2004

I think this is great news - the idea of my daughter maybe not having to live with this for the rest of her life is quite exciting. Does anyone know that if this drug gets approved, what age do you have to be? It think I heard that 13 was the magic number for Xocloir. Also, Peg, I commend your son for wanting to be in the trial - people like him pave the way for all of our little ones.

On Feb 27, 2004

deleted

[This message has been edited by Nutternomore (edited February 27, 2004).]

On Feb 27, 2004

I heard there were trials going on at the Mayo Clinic in Rochester, MN. I wonder - Maybe Xolair wold be great for those PA sufferers who also have Asthma? Looking on the bright side.

On Feb 27, 2004

Quote:

Originally posted by MICHELE03142002: [b]........Also, Peg, I commend your son for wanting to be in the trial - people like him pave the way for all of our little ones.[/b]

Well thanks, his desire is purely selfish, so he can begin to maybe live a normal life in respect to peanuts anyway. With our luck he'll be in the group that gets the placebo.

But in any case I can't find a trial anyway. I'm going to keep trying.

Peg

On Feb 27, 2004

Quote:

Originally posted by MICHELE03142002: [b]I think this is great news - the idea of my daughter maybe not having to live with this for the rest of her life is quite exciting. Does anyone know that if this drug gets approved, what age do you have to be? It think I heard that 13 was the magic number for Xocloir. Also, Peg, I commend your son for wanting to be in the trial - people like him pave the way for all of our little ones.[/b]

As far as what age one has to be, the approval for Xolair by the FDA came from studies in asthma. If/when Xolair gets tested for nut allergy (more of a when than ian if in my opinion) it will undoubtedly be tested (and therefore cleared by the FDA) in children much younger than 12.

On Feb 27, 2004

Quote:

Originally posted by Lisa V: [b]I heard there were trials going on at the Mayo Clinic in Rochester, MN. I wonder - Maybe Xolair wold be great for those PA sufferers who also have Asthma? Looking on the bright side.[/b]

My guess is that clinical trials won't get off the ground for at least a couple months. These thing takke time to plan, and each individual center has to get what is called "IRB approvval", which vaires from place to place in terms of how efficiently they can review research protocols.

On Feb 27, 2004

I'm new to the PA world (son diagnosed this week), but I see this news as much more bad than good.

Because of this fiasco, Tanox is no longer developing TNX-901, which appears to be further along and much more promising than Xolair for PA. Now, everyone has to take several steps backwards and keep their fingers crossed that Xolair will show the same promise that TNX-901 did.

This is absurd to me. Am I missing something here?

On Feb 27, 2004

Quote:

Originally posted by mxbender: [b]I'm new to the PA world (son diagnosed this week), but I see this news as much more bad than good.

Because of this fiasco, Tanox is no longer developing TNX-901, which appears to be further along and much more promising than Xolair for PA. Now, everyone has to take several steps backwards and keep their fingers crossed that Xolair will show the same promise that TNX-901 did.

This is absurd to me. Am I missing something here?[/b]

This may not be as bad as you think. Xolair is allready farther along in the eyes of the FDA than TNX ever was. Xolair has been approved for use in asthma, which means that its safety has been tested. All we need to know now is whether it is as effective as TNX was in the small trials that were so well publicized from the New England journal of medicine. I believe that Xolair will be every bit as effective (I am a physician and a scientist, I have som knowlege of this topic). The companies did this because they thought it would be easier to get Xolair approved in my opinion.

[This message has been edited by darenberg (edited February 27, 2004).]

On Feb 27, 2004

I too was upset that they stopped development of the more advanced drug that would be approved quicker because of this lawsuit.

Gotta love the drug companies.

On Feb 27, 2004

Quote:

Originally posted by mxbender: [b]I'm new to the PA world (son diagnosed this week), but I see this news as much more bad than good.

Because of this fiasco, Tanox is no longer developing TNX-901, which appears to be further along and much more promising than Xolair for PA. Now, everyone has to take several steps backwards and keep their fingers crossed that Xolair will show the same promise that TNX-901 did.

This is absurd to me. Am I missing something here?[/b]

P.S. Mx..sorry to hear about your son. My son's first reaction was a few weeks ago as well. We just got his RAST test results back. So we are only slightly "ahead" of you in this process. Best of luck and wishes from my family to yours as you learn to live with this.

[This message has been edited by darenberg (edited February 27, 2004).]

On Feb 27, 2004

Quote:

Originally posted by momma2boys: [b]I too was upset that they stopped development of the more advanced drug that would be approved quicker because of this lawsuit.

Gotta love the drug companies.[/b]

My point has been that the perception that TNX was more advanced is wrong. Xolair has been around for longer, and has been more rigorously scrutinzed at the FDA advisory comittee already. The only bad news is the "efficacy" issue, nbut both antibodies target IgE, and there is no obvious reason to think that Xolair works in asthma, but won't work in another IgE mediated condition.

On Feb 27, 2004

Could this be the mystery drug my doc spoke to me about in the winter? He said there might be a new drug for asthma and pa. He also said we'd talk more about it in the spring! It is spring almost and we have an appointment next wednesday. By then it is spring(to me) and I'll ask him again about it. I was unaware of any pending law suits or problems I hope this doesn't hold up any help my son was going to get.That'll be another dashed hope [img]http://uumor.pair.com/nutalle2/peanutallergy/frown.gif[/img]

On Feb 27, 2004

Quote:

Originally posted by darenberg: [b] This may not be as bad as you think. Xolair is allready farther along in the eyes of the FDA than TNX ever was. [/b]

I respectfully disagree here. BOTH drugs should continue to be tested and BOTH should be made available for everyone. There are many many different types of drugs for environemental allergies, many different pain medications, many different drugs for depression etc. And the reason is because there is no one drug that is effective for every person. So why should there be a limitation on the drugs for peanut allergies???

From what I have been reading, Xolair will be available a year after the other drug probably would have been. Plus, there will probably be people for whom Xolair do not work. or perhaps Xolair will work for a while but no longer. This is very common for many types of drugs. I am sick that this is allowed to happen. It is all because of money, not because one drug is better than the other.

My hubby sent me an email. The subject was : this is B&*(&(*T. The body was a copy of an article about this topic. I agree with him.

And I agree with the woman who posted that she sees more bad than good.

------------------ Ellen Allergic to Shellfish/ Mom to Jesse 9/01 who has PA

On Feb 27, 2004

Quote:

Originally posted by ElleMo: [b] I respectfully disagree here. BOTH drugs should continue to be tested and BOTH should be made available for everyone. There are many many different types of drugs for environemental allergies, many different pain medications, many different drugs for depression etc. [/b]

What you are missing is that there ARE many different types of drugs for these other conditions, but TNX and Xolair just aren't that different. They are both antibodies directed against IgE. They have [b]identical[/b] mechanisms of action, and [b]ONLY ONE OF THEM IS ALREADY FDA APPROVED[/b]. Take the cynical view if you must. With my lenses that have spent the last 15 years doing basic biomedical research, I am looking at a glass that is half full.

On Feb 27, 2004

Quote:

Originally posted by darenberg: [b] What you are missing is that there ARE many different types of drugs for these other conditions, but TNX and Xolair just aren't that different. They are both antibodies directed against IgE. They have [b]identical[/b] mechanisms of action, and [b]ONLY ONE OF THEM IS ALREADY FDA APPROVED[/b]. Take the cynical view if you must. With my lenses that have spent the last 15 years doing basic biomedical research, I am looking at a glass that is half full.

[/b]

I am taking the realist approach. BOTH drugs should be made available to the public; just because one is FDA approved does not make it OK to stop the research on the other. The decision is based purely on money.

They may both have the same mechanism of action, but that does not mean they are the SAME drug. I am sure they react differently in the body. One may have more tolerable side effects than another. Going back to my previous posts, for example, SSRI class of drugs are very similar, in clinical terms they inhibit the process of re-uptake of serotonin; there are 3 types that I can think of off the top of my head -- Prozac, Zoloft, and Paxil-- all of which are available and all of which react better for some people than others.

I just don't see any good new in this. I can't write it enough times -- BOTH drugs should be available and one should not be shelved because of drug companies greed.

------------------ Ellen Allergic to Shellfish/ Mom to Jesse 9/01 who has PA

[This message has been edited by ElleMo (edited February 27, 2004).]

On Feb 27, 2004

Some related threads:

[url="http://uumor.pair.com/nutalle2/peanutallergy/Forum1/HTML/003822.html"]http://uumor.pair.com/nutalle2/peanutallergy/Forum1/HTML/003822.html[/url]

[url="http://uumor.pair.com/nutalle2/peanutallergy/Forum3/HTML/001101.html"]http://uumor.pair.com/nutalle2/peanutallergy/Forum3/HTML/001101.html[/url]

I'm seeing Dr. Sampson on Wednesday so if I remember, I'll try to ask if him about the tnx update.

Allison

On Feb 27, 2004

Just curious, why would Xocloir be okay for peanut allergy in younger children and not okay for asthma in younger childen? Also, when do they expect this drug to be available if it does pass clinical trials- are they starting in phase III? I would think, like Tanox, it would be fast-tracked through the FDA because there is no other drugs, at this time, available.

On Feb 27, 2004

Quote:

Originally posted by MICHELE03142002: [b]Just curious, why would Xocloir be okay for peanut allergy in younger children and not okay for asthma in younger childen? Also, when do they expect this drug to be available if it does pass clinical trials- are they starting in phase III? I would think, like Tanox, it would be fast-tracked through the FDA because there is no other drugs, at this time, available.[/b]

As to the asthma question...many clinical trials in asthma exclude young children because of their inability to do pulmonary function tests reliably (something that is necessary for any asthma clinical trial as an objective measure of the effectiveness of the drug). Since the trials will only enroll children above a certain age, the FDA will grant approval for use only in those age groups. Once a drug is approved, it is quite common for doctors to prescribe the drug for patients outside the "approved" group. My own practice is to inform my patients of these issues and have them understand the potential risks & benefits if it is a new class of drug.

I cannot answer your second question, but agree that it is likely to be fast-tracked for the same reasons TNX [b]was[/b] on the fast track.

[This message has been edited by darenberg (edited February 27, 2004).]

On Mar 1, 2004

.

[This message has been edited by deegann (edited February 09, 2005).]

On Mar 1, 2004

My 4 year old PA son appears to be getting worse. Just today we received testing results that his PA is now joined by allergies to tree nuts, potatoes and eggs. His PA results were "off the chart".

Will TNX-901 help with these other food allergies?

If the positive news continues, how long till the can expect some peace of mind? Can we ever expect peace of mind?

------------------ Pete Ferraro [url="http://www.FerraroFamily.org"]http://www.FerraroFamily.org[/url]

On Mar 2, 2004

Quote:

Originally posted by deegann: [b] I certainly hope they wouldn't give a placebo then feed peanut to anyone with an allergy! With something concrete to measure (Ige levels)to test if the drug is working, would they even need to have a control group taking a placebo?

[/b]

Hi Deegan, I am currently in the tanox study. In order to accepted into the study, all participants went through an initial screening which including a history, physical, and blood work (normal CBC, etc and CAP RAST). We also were skin tested for peanut protein at different concentrations. If both the CAP RAST and skin test were positive, we had to do double blinded food challenge to peanut flour. If there was a reaction during the challenge (on the "peanut day"), then we could participate in the study. For the first phase, there was in fact a placebo. One of my friends in the study actually got the placebo. After several months, we were re-challenged. Those of us in the highest medication dosage did VERY well. The people in the lowest group and placebo did not do well.

I don't know if there will be a placebo in the Xolair trials, however, I suspect participants WILL have go through peanut challenges. ALthough the RAST testing is a helpful and non-invasive guide to predict who will have a reaction, it is NOT conclusive and it does not predict the severity of a reaction. It is more of a probability of the liklihood that a reaction will occur. Also, for most people taking anti-IgE, the amount of free IgE in the blood (as apposed to the IgE bound to the drug) drops SIGNIFICANTLY, however, it is still possible to have a reaction. The only way relatively accurate way to test the impact is through doing a challenge.

Allison

On Mar 2, 2004

Quote:

Originally posted by PeteFerraro: [b]My 4 year old PA son appears to be getting worse. Just today we received testing results that his PA is now joined by allergies to tree nuts, potatoes and eggs. His PA results were "off the chart".

Will TNX-901 help with these other food allergies?

If the positive news continues, how long till the can expect some peace of mind? Can we ever expect peace of mind?[/b]

Pete...both of these drugs target IgE, which is the "culprit" in all food allergy, so it is likely that all allergic reactions to foods will be blunted just as they were in the original trial to peanut allergens alone.

The reason for testing them in such a narrowly defined group is that it makes the results easier to interpret. Once one of these drugs is approved for treatment (prevention) of anaphylactic reactions, no right-minded allergist would withold them from a tree-nut allergic patient just because the FDA approval was only for peanut allergies (my opinion only).

On Mar 2, 2004

[url="http://www.siliconvalley.com/mld/siliconvalley/8016694.htm"]http://www.siliconvalley.com/mld/siliconvalley/8016694.htm[/url]

Thoughts on this article?

Wondering if the 2011 date is as close to a more definitive answer as anyone is going to get?

Disclaimer: I am not offering advice in any manner or form. I do not guarantee the accuracy, content, or currentness of the link in this post.

On Mar 2, 2004

Hello, My son has been on Xolair since September. It has been a "Godsend" for us. He has severe food allergies, chronic urticaria, environmental allergies, and severe asthma. Before Xolair, he was having at least one reaction a week and was on nine different medications. Since taking Xolair, he has not had any hives or food reactions (Xolair has not been approved for the food allergies-We are still very careful with what he eats.)His medications have been reduced to less than half. He was a very sick child before taking Xolair. He now can enjoy life and go outside to play without getting sick. Xolair may not be for everyone, but for him it has been a miracle.

On Mar 2, 2004

I'm so bummed xolair is not available in Canada. That is what they told me when I called. I was hoping against all odds that it was. My son is allergic to anything hairy furry pollen producing.With pa and tna. He has been on every drug available to him for asthma with no success. [img]http://uumor.pair.com/nutalle2/peanutallergy/frown.gif[/img] I was hoping to get him off some of these drugs and on with life.

On Mar 2, 2004

Quote:

Originally posted by MommaBear: [b] [url="http://www.siliconvalley.com/mld/siliconvalley/8016694.htm"]http://www.siliconvalley.com/mld/siliconvalley/8016694.htm[/url]

Thoughts on this article?

[/b]

The article is interesting. The cancer scare is something that will have to be sorted out, but the likelihood that inhibition of IgE leads to cancer is extremely remote. Cancer research is what I spend 80% of my time doing, and there are always surprises in clinical trials. Most of them turn out to have nothhig to do with the drug in question. The FDA took into account the non-plausibility of an anti-IgE antibody causing cancer in recommending Xolair's approval. The follow up data is something they will look for, and they have asked for similar follow-up on other drugs.

One example is Prilosec. In early studies in animals, some rats given Prilosec developed benign tumors in their stomachs. When Prilosec was first approved, it was only approved for use over an 8 week period of time because of this. Since then, the makers have provided follow-up data that resulted in that warning being removed, and the approval for the drug is for extended, long-term use.

I would have no hesitation to use Xolair on myself (or my son), and have prescribed it for two of my own patients. One has had signifivcant improvement in her asthma, and the other is too soon to tell.

[This message has been edited by darenberg (edited March 02, 2004).]

On Mar 2, 2004

Darenberg, this is a little off topic, but what kind of physician are you?

On Mar 2, 2004

Quote:

Originally posted by darenberg: [b] The article is interesting. The cancer scare is something that will have to be sorted out, but the likelihood that inhibition of IgE leads to cancer is extremely remote. Cancer research is what I spend 80% of my time doing, and there are always surprises in clinical trials. Most of them turn out to have nothhig to do with the drug in question. The FDA took into account the non-plausibility of an anti-IgE antibody causing cancer in recommending Xolair's approval. The follow up data is something they will look for, and they have asked for similar follow-up on other drugs.

One example is Prilosec. In early studies in animals, some rats given Prilosec developed benign tumors in their stomachs. When Prilosec was first approved, it was only approved for use over an 8 week period of time because of this. Since then, the makers have provided follow-up data that resulted in that warning being removed, and the approval for the drug is for extended, long-term use.

[/b]

how long did that take? (the determination for Prilosec?) Is there a "warning" for Xolair --- should there be -- (that would be removed if indicated -- similiar to how you describe events surrounding Prilosec)?

I mean, [i]this[/i] article mentions an increase from 0.2% to 0.5% (How many "fold increase" is that?) :

(scroll down to "Regulatory News")

[url="http://www.americanhealthline.com/samplecontent/printversion.html"]http://www.americanhealthline.com/samplecontent/printversion.html[/url]

Don't mind me, I'm just an "informed consent" type of individual. And a little edgy too. [img]http://uumor.pair.com/nutalle2/peanutallergy/cool.gif[/img]

Disclaimer: I am not offering advice in any manner or form. I do not guarantee the accuracy, content, or currentness of the link in this post.

On Mar 2, 2004

My son's immunologist is concerned about my son's food allergies enough that they are investigating the possibility of my son entering the study when/if it young children are involved in the study. She said that would be an excellent candidate to enter the study.

I have many questions and concerns. This will be the most difficult question that my wife and I ever have had to make.

The cancer risks are scary, but my bigger concern is what happens if we start the trail and something happens (legal, medical, financial, whatever) and the study and or production of Xolair is suspended. What happens to the immune system after Xolair is removed from the equation? Do food allergies get worse? Is there an immune system rebound?

Sadly, other considerations are financial. What happens after the study if my insurance company decides they won't pay for treatment? The cost of this drug is scary. I'm not complaining. The investment in R&D needs compensated. I'm just concerned that for whatever reason treatment may go away.

What happens to the immune system when Xolair goes away?

What happens to the immune system when some virus like the bird flu or sars comes along?

What happens if after long term use the immune system revolts and attacks the body?

This is really scary. To me, just a dumb parent almost overwhelmingly scary.

While food allergies are scary, long term drugs like Xolair are almost even scarier.

Perhaps my concerns are unfounded?

------------------ Pete Ferraro [url="http://www.FerraroFamily.org"]http://www.FerraroFamily.org[/url]

On Mar 2, 2004

Quote:

Originally posted by PeteFerraro: [b]What happens to the immune system when Xolair goes away?

What happens to the immune system when some virus like the bird flu or sars comes along?

What happens if after long term use the immune system revolts and attacks the body?

This is really scary. To me, just a dumb parent almost overwhelmingly scary.

While food allergies are scary, long term drugs like Xolair are almost even scarier.

Perhaps my concerns are unfounded? [/b]

I would never say your conerns are unfounded, and I have few ansers, mostly guesses to your questions. One answwer I have is that IgE (the target of these drugs) is not required for immune defenses against viruses (flu. colds, "SARS" etc.,). Immunologists believe that IgE is present to protect us against parasitic infections, which fortunately are almost unheard of in Western society. I would not want ot be on Xolair and living in a tropical third world climate though.

On Mar 2, 2004

Quote:

Originally posted by ajinnj: [b]Darenberg, this is a little off topic, but what kind of physician are you?[/b]

I am in Pulmonary & Critical Care. Feel free to e-mail me if you have other "off topic" questions

[This message has been edited by darenberg (edited March 02, 2004).]

On Mar 2, 2004

Quote:

Originally posted by darenberg: [b] I would never say your conerns are unfounded, and I have few answers, mostly guesses to your questions. One answer I have is that IgE (the target of these drugs) is not required for immune defenses against viruses (flu. colds, "SARS" etc.,). Immunologists believe that IgE is present to protect us against parasitic infections, which fortunately are almost unheard of in Western society. I would not want ot be on Xolair and living in a tropical third world climate though.

[/b]

On Mar 2, 2004

Quote:

Originally posted by MommaBear: [b]

Don't mind me, I'm just an "informed consent" type of individual. And a little edgy too. [/b]

the link you posted makes a very important point that many people worried about "cancer risk" wit Xolair have either ignored, or don't understand.

All we know about cancers is that the changes that lead to cancer precede the appearance of the cancer by many years. This has been definitively establised for colon, lung, prostate, skin, and cervical cancers (all the tissues where scientists regularly have access to pre-cancerous lesions).

The idea that Xolair "caued" these cancers is almost totally implausible in my opinion, since most of these cancers were diagnosed within 6 months of starting the treatment. Keep in mind that people in clinical trials are followed VERY closely by the treating doctors, so other medical conditions are likely to come to light during the course of a trial.

Another (equally mis-leading) way of looking at this is that 99.5% of patients on Xolair remained cancer free!

On Mar 2, 2004

[

On Mar 3, 2004

Quote:

Originally posted by darenberg: [b] the link you posted makes a very important point that many people worried about "cancer risk" wit Xolair have either ignored, or don't understand.

Everything we know about cancers tells us that the changes that lead to cancer precede the appearance of the cancer by [b]many[/b] years. This has been definitively establised for colon, lung, prostate, skin, and cervical cancers (all the tissues where scientists regularly have access to pre-cancerous lesions).

The idea that Xolair "caued" these cancers is almost totally implausible in my opinion, since most of these cancers were diagnosed within 6 months of starting the treatment. Keep in mind that people in clinical trials are followed VERY closely by the treating doctors, so other medical conditions are likely to come to light during the course of a trial.

Another (equally mis-leading) way of looking at this is that 99.5% of patients on Xolair remained cancer free![/b]

On Mar 3, 2004

Quote:

Originally posted by darenberg: [b] The idea that Xolair "caued" these cancers is almost totally implausible in my opinion, since most of these cancers were diagnosed within 6 months of starting the treatment. [/b]

In general, is it ever any single item that "causes" cancer? Or is it a combination of "influencing" factors? Can existing cancer be "influenced"? I don't know? Anyone?

Quote:

Originally posted by darenberg: [b] Keep in mind that people in clinical trials are followed VERY closely by the treating doctors, so other medical conditions are likely to come to light during the course of a trial. [/b]

Completely unrelated, but you're comments struck a chord with me. [img]http://uumor.pair.com/nutalle2/peanutallergy/smile.gif[/img]

Would you believe my father's lung ca [b]and[/b] AAA were both [b]discovered[/b] the night he entered the hospital emergently? The ca was well advanced and he had a pleural effusion. The AAA was ruptured at the renal artery (10cm x 8cm). He was under the care of several cardiologists, an intern, and a pulmonologist. He was getting blood tranfusions every 4-6 weeks for over 8 years for what they felt was "angiodysplasia". He also had a daughter who was a Critical Care RN. (Whom he lived with).

I *believe* it was Divine intervention. Maybe it's just me. (He had never been subjected to being incapacitated and never wanted to be. He was 84 and completely independent. He refused surgery.

Disclaimer: I am not offering advice in any manner or form.

On Mar 3, 2004

I had my appointment with Dr. Sampson today. Although I totally forgot to ask Dr. Sampson himself about the future of the study, I spoke with Sally Noone (his research coordinating nurse practioner). The participants already involved in the tnx-901 study are going to continue getting the drug until Xolair is approved for food allergies (and it will). However, the actual study has been completely haulted (meaning no more additional participants) and will not resume. Tanox will NOT be approved and will NOT be on the market, EVER! However, studies for the xolair are scheduled to begin VERY soon. THe study is open to people ages 6-70ish with severe peanut allergy. I don't know when official recruitment for the study begins but if anyone is interested you should probably contact Dr. Sampson's office. Besides Mount Sinai in NYC and most likely National Jewish is Denver, I do not know where the are study sites will be located-- again if you are interested my advice is to either contact someone at Mount Sinai or call National Jewish.

Allison

On Mar 6, 2004

To request that the trials continue, writing or calling Tanox directly may be more effective. SLAM them with your opinions. ie: I would sell my house to pay for a drug that would help me lead a normal life.

Tanox, Inc. Executive offices: 4888 Loop Central Drive, Suite 820 Houston, TX 77081-2225

Laboratory facilities: 10301 Stella Link Houston, TX 77025-5497 Phone: 713-578-4000 Fax: 713-578-5002 Email: [email]info@tanox.com[/email]

------------------

On Mar 6, 2004

In all honesty, I don't think contacting tanox is going to help at this point. The courts ordered tanox to stop producing the drug because it infringed on the other two companies "rights" (since they produced a drug so similar). There has already been so much media coverage about the tanox drug/ legal problems that if previous public pressure didn't convince the companies to resolve their problems I doubt at this point they will. On a positive note, I really truly think Xolair will be approved relatively quickly since it is already approved for asthma and Novartis and Genentech are using some of the data from the Tanox study.

Allison

On Mar 7, 2004

Quote:

[B[]n a positive note, I really truly think Xolair will be approved relatively quickly since it is already approved for asthma and Novartis and Genentech are using some of the data from the Tanox study.

Allison[/B]

Allison, thanks for saying this. I have believed this is the case as well. I value your insight as a participant in the original trials, and wish you the best of luck with this in the future. Your posts in these forums are well thought out and insightful.

On Mar 7, 2004

Hi Allison,

How long have you been taking the drug now? Would you mind telling what the side effects have been for you?

Judy

On Mar 7, 2004

Quote:

Originally posted by JudyH: [b]Hi Allison,

How long have you been taking the drug now? Would you mind telling what the side effects have been for you?

Judy[/b]

Hi Judy, I've been in the study for 2.5 years. In the beginning of this thread (toward the bottom of the first page), I included some links to other similar threads, where I give very lengthy details of my experience in the study. If you have additional questions, please feel free to ask and I will do my best to get back to you.

Allison

[This message has been edited by ajinnj (edited March 07, 2004).]

On Mar 14, 2004

I have not kept up with current Tanox vs. Xolair info..but here's my take on this whole debate. I'm still very confused/concerned that Tanox has been dropped in favor of "one" other drug. The legal battle that has resulted from this speaks for itself. It is shameful. Manipulation by trial lawyers and pharm. companies (acting on their own greedy behalf) to influence the FDA not to allow two drugs on the market that are life-altering/life-saving to proceed sickens me. We live in a democracy that has always prided itself on free enterprise..We have sunk to a new low..Go to court to "legally" wipe out the competiton. What is the usual result when there is just one supplier of something?? Does cost go down when there is a complete monopoly? Or does price gouging usually occur? You would expect more ethics from the health care industry.

Common sense tells us that the ideal drug would be a drug that targets IGE-specific food allergies. That is the premise that the current immuno-therapy is based. If you are allergic to ragweed, you aren't going to the doc. and getting shots for dogs, cats, etc. If I'm not mistaken, Tanox was "peanut" specific. I don't want/need all the IGE out of my children's blood! But we do need nut allergy treatment. I suspect (as complex as the human body is that science will never know all the functions of IGE). Medical research is not an infallible field...they are not God. The human body is still a mystery in many fields.

My dc should have access to a drug like Tanox. When you have a headache, do you buy a multiple symptom cold reliever combo. just to get the pain reliever med.? You can't turn the TV on without seeing a commerical about acid reflux..heartburn..or depression...an a multitude of drugs aimed at relieving the same symptoms. Tanox was developed, was in clinic trials, and had good results...to toss it out is shameful and wasteful. It is a slap in our face by the pharm. companies that a drug has been developed that is peanut-specific but the greedy bullies down the street don't want anyone working their corner. They beat up Tanox...offered them some money to forget about the whole ordeal..and still maintain control of their turf. It is shameful.

On Mar 14, 2004

Quote:

Originally posted by FromTheSouth: [b] Common sense tells us that the ideal drug would be a drug that targets IGE-specific food allergies. That is the premise that the current immuno-therapy is based. If you are allergic to ragweed, you aren't going to the doc. and getting shots for dogs, cats, etc. If I'm not mistaken, Tanox was "peanut" specific. I don't want/need all the IGE out of my children's blood! But we do need nut allergy treatment. I suspect (as complex as the human body is that science will never know all the functions of IGE). Medical research is not an infallible field...they are not God. The human body is still a mystery in many fields. [/b]

Actually the tanox drug is not peanut specific. Unlike traditional immunotherapy, the tanox helps all allergies by targeting the part of the immune system that causes allergic reactions (IgE). Traditional immunotherapy and anti-IgE therapy work completely different mechanisms: immunotherapy tries to build up tolerance by slowing introducing the allergen to the body (allergen specific); whereas, anti-IgE binds to the free IgE an inhibits the production of more IgE (not allergen specific). Many doctors think that patients who in the past have not been able to tolerate traditional immunotherapy may benefit from a combination of the two treatments-- the anti-IgE therapy will help prevent severe allergic reactions to the allergy shots.

I just wanted to add, Dr. Sampson skin tested me a few weeks ago to several peanut, sesame, dust mites, trees, grass, cockroach, mold, and some other things. The only things that came up were peanut, sesame, and trees (and the reactions were so small that they almost didn't count)-- prior to starting the tnx-901, I would need several days of oral benadryl because my reactions to the skin testing were so severe. Dr. Sampson was so impressed at how significantly the tanox improved my environemtnal allergies.

With that said, it is very sad that legal issues got in the way of approving a potentially life-saving drug.

Allison

On Mar 14, 2004

Allison - Thank you so much for your posts. I always appreciate your experience and insight. I'm very glad to hear your test results were so improved. You've given me hope for my little ones. Thank you!

------------------ Sally

On Mar 16, 2004

Maybe I missed something in the previous posts, but I have a question. If Xolair is for asthma but may be used for people with PA as well, would it be used for people with just PA and no asthma? I'm wondering what the affects would be for someone who is just PA, with no asthma (like my DD).

It is a shame about Tanox, because it looks like it was developed for food allergies.

On Mar 16, 2004

I had heard that Xolair and TNX-901 were quite similar. The both attacked the Allergic process through binding with the IGE blah, blah, blah. Does anyone think that the PA community (as well as other anaphylactic allergies) could be served as well by Xolair as Allison seemed to be with the TNX-901? I hope so! It would be great if there was one treatment for those of us who have more than one serious allergy. Such as peanuts AND shellfish, for example.

On Mar 23, 2004

raising

On Mar 23, 2004

[url="http://my.webmd.com/content/article/84/98084.htm"]http://my.webmd.com/content/article/84/98084.htm[/url]

You are in Diseases & Conditions.

Asthma Drug Improves Allergies Too

60% Report Excellent to Good Control of Allergy Symptoms With Xolair

By Melissa Schorr WebMD Medical News Reviewed By Michael Smith, MD on Monday, March 22, 2004 > Email to a friend > Printer-friendly version

March 22, 2004 (San Francisco) -- A recently approved asthma drug -- Xolair -- appears to also improve allergy symptoms.

In a study presented at a meeting of asthma and allergy specialists, patients with moderate to severe asthma and allergic rhinitis -- more commonly known as "hay fever" -- said Xolair, a new type of bioengineered drug, reduced symptoms and improved the quality of their life.

Xolair was FDA approved last year for people with asthma caused by allergies. It is also being investigated as a treatment for those who also have persistent hay fever -- characterized by an itchy, running nose.

For patients who have both allergic asthma and persistent hay fever, Xolair is effective, study researcher Ulf Harnest, MD, of ClinGuard GmbH Institute for Medical Treatment Strategies in Munich, Germany, said during his presentation. "It is rated effective by patients, and most important, it is well tolerated. He presented his study Sunday at the annual meeting of the American Academy of Allergy, Asthma, & Immunology.

The researchers presented new data from a study that followed 405 patients with both moderate to severe allergic asthma and persistent allergic rhinitis. During a 28-week period, half the patients took Xolair and the other half took a placebo. The patients were between the ages of 12 and 74.

The research was funded by Novartis Pharma AG and Genentech, makers and distributors of Xolair and a WebMD sponsor.

Xolair is typically given by an injection under the skin every two or four weeks. All the patients were also treated with other conventional asthma and allergy treatments as needed. Xolair is a first of its kind drug -- called a monoclonal anti-IgE antibody. It works by blocking the effects of an antibody in the body that causes allergies and inflammation.

Before treatment, both groups scored equally on quality of life questionnaires. But after treatment, 58% of those treated with Xolair improved, compared with only 41% of those on placebo. In addition to improvement in asthma symptoms, when compared with placebo, patients on Xolair improved significantly in all measured quality of life areas, including activities, sleep, eye, and nasal allergy symptoms.

Control of hay fever symptoms was rated as excellent/good by 61% of Xolair-treated patients compared with 36% of placebo-treated patients.

Similarly, 66% of the Xolair-treated patients rated control of their asthma symptoms as excellent/good, while only 53% of placebo-treated patients did so.

Allergy specialist Sami L. Bahna, MD, who attended the presentation, was not impressed with the relatively small difference reported between the patients treated with Xolair and those on placebo, especially in regards to their breathing capacity. Bahna is professor of pediatrics and medicine and chief of allergy & immunology at the Louisiana State University Health Sciences Center in Shreveport.

"I was surprised that the study did not show a more favorable effect, as previous studies in asthma did," he tells WebMD.

In addition, some of the patients did experience some side effects, such as migraine headaches and injection site reactions. In the Xolair patients, 17% reported side effects, versus 12% in the placebo group. And 1.4% of those on Xolair and 1.5% on placebo encountered more serious side effects.

SOURCES: 60th annual meeting of the American Academy of Allergy, Asthma, & Immunology, San Francisco, March 19-23, 2004, abstract 48, 602, Presented March 22, 2004.Sami L. Bahna, MD, professor, pediatrics and medicine; chief, allergy & immunology, Louisiana State University Health Sciences Center, Shreveport.

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