xolair

Posted on: Sat, 04/19/2003 - 12:31am
mmgshih's picture
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I thought I would post this in case anyone is interested in attending the meeting.

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
Name of Committee: Pulmonary-Allergy Drugs Advisory Committee.
General Function of the Committee: To provide advice and
recommendations to the agency on FDA's regulatory issues.
Date and Time: The meeting will be held on May 15, 2003, from 8
a.m. to 5 p.m.
Location: Holiday Inn, The Ballrooms, Two Montgomery Village Ave.,
Gaithersburg, MD.
Contact Person: Kimberly Littleton Topper, Center for Drug
Evaluation and Research (HFD-21), Food and Drug Administration, 5600
Fishers Lane (for express delivery, 5630 Fishers Lane, rm. 1093),
Rockville, MD 20857, 301-827-7001, or FDA Advisory Committee
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC
area), code 12545. Please call the Information Line for up-to-date
information on this meeting.
Agenda: The committee will discuss biologics license application
(BLA) 103976, XOLAIR Omalizumab (Humanized Monoclonal Antibody to Human
IgE) by Genentech, Inc., for the treatment of allergic asthma.
Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person by May 8, 2003.
Oral presentations from the public will be scheduled between
approximately 1 p.m. and 2 p.m. Time allotted for each presentation may
be limited. Those desiring to make formal oral presentations should
notify the contact person before May 8, 2003, and submit a brief
statement of the general nature of the evidence or arguments they wish
to present, the names and addresses of proposed participants, and an
indication of the approximate time requested to make their
presentation.
Persons attending FDA's advisory committee meetings are advised
that the agency is not responsible for providing access to electrical
outlets.
FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact Kimberly Littleton
Topper at least 7 days in advance of the meeting.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

Posted on: Thu, 06/19/2003 - 7:42am
Danielle's picture
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Thank you for posting this.

Posted on: Mon, 08/04/2003 - 1:35am
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I spoke recently with a Novartis rep regarding Xolair. Novartis has a negotiating division that contracts with your own insurance company to insure coverage. Within the first two weeks of availability, no insurance companies had denied coverage of the product. Phase III trials are supposedly in progress for the peanut/tree nut indication. Many allergists are making sure the patient qualifies for coverage.

Posted on: Mon, 08/04/2003 - 10:27am
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I see you stated that they will begin PHASE III for testing XOLAIR for peanut/tree nut allergy - can you tell me more about this? When are they starting these trials and why would they begin in Stage III and not Stage I? I hope they start soon, since it seems that TANOX could be a lost cause - at least for a while.

Posted on: Tue, 08/05/2003 - 12:17am
Bootsy's picture
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Here is a link regarding Xolair, which has been FDA approved. I haven't had a chance to look extensively through it yet, but thought I would post it.
[url="http://www.xolair.com/index.jsp"]http://www.xolair.com/index.jsp[/url]

Posted on: Tue, 08/05/2003 - 1:38am
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My contact at Novartis said that Xolair's trials for the peanut indication were underway. Since efficacy trials have been completed for the other indications, they could jump to phase trialing. Hope this answers your question. If the patient has moderate to severe allergic rhinitis and/or asthma, they could receive this product under that diagnosis.

Posted on: Tue, 08/12/2003 - 2:13am
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The reason the Xolair trials for peanut/ tree nut can start at Phase III instead of Phase I is because Xolair has already been proven "safe". Also I think Xolair was able to use some of the data from the tanox studies. I think Dr. Sampson at Mt. Sinai and probably others are looking for participants (but don't quote me on that).
Allison

Posted on: Tue, 08/12/2003 - 3:35am
esmom's picture
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any idea on getting study infomation and
what the requirements are to be in the
study

Posted on: Tue, 08/12/2003 - 2:23pm
ajinnj's picture
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maybe call the xolair manufacturers directly and ask them if they need participants for the peanut trials and/ or if they could tell you the locations of the study sites as well as the contact person that way you can pick which site is closest to you (if the studies are still open). I don't know if you've ever been involved in any kind of study before but my study is very time consuming so it might be rough on a young kid. I know in my study there is a participant that flies from toronto to new york every 4 weeks for the shots and and the financial componsation is very minimal. i still highly recommend it i just wanted to make you aware of some of the negative sides that you may not have thought of. hope this helps a little. keep us updated if you hear anything
Allison

Posted on: Wed, 08/13/2003 - 12:49am
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Another suggestion:
You may try these two websites. I did a quick check and nothing came up for "Xolair" or "peanut allergy." That probably means enrollment has not yet begun or the FDA has yet to approve the study (if a protocol was really submitted). The FDA approval of the study protocol can take several months.
Good luck!
Troy
[url="http://www.centerwatch.com"]http://www.centerwatch.com[/url]
[url="http://www.clinicaltrials.gov"]http://www.clinicaltrials.gov[/url]

Posted on: Wed, 05/14/2003 - 10:00am
Corvallis Mom's picture
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Oh dear. This really does sound like the proverbial rock and a hard place, doesn't it?
[url="http://money.cnn.com/2003/05/14/news/companies/xolair.reut/"]http://money.cnn.com/2003/05/14/news/companies/xolair.reut/[/url]

Posted on: Thu, 05/15/2003 - 10:09pm
esmom's picture
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Joined: 07/25/2001 - 09:00

all over the news, wondering what pa.com people are thinking and hearing???

Posted on: Thu, 05/15/2003 - 11:21pm
Joanne's picture
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[url="http://www.nytimes.com/2003/05/16/business/16DRUG.html"]http://www.nytimes.com/2003/05/16/business/16DRUG.html[/url]
[This message has been edited by Joanne (edited May 16, 2003).]
[This message has been edited by Joanne (edited May 16, 2003).]

Posted on: Fri, 05/16/2003 - 12:39am
choguy's picture
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Part of the problem with this drug is that it blocks the action of all IgE's present in the body in a non-selective way (non-specific antagonist). The IgE antibodies are in each of us do have a necessary biological function. Who knows what can happen if you esentially block the function of one part of your immune system for a long period of time. There are viruses that can cause cancer if left untreated. Is this what is happening? Who knows...
Disclaimer here: My company is working on a medication that would compete directly with Xolair albeit many years from now. The function of this drug would be VERY specific to asthma alone. Needless to say, if my company's drug works it would leave Xolair in the dust. Can't say more without risking my job!
Troy

Posted on: Thu, 06/19/2003 - 2:23am
Heather2's picture
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Joined: 09/25/2001 - 09:00

Good news about Xolair in today's Boston Globe:
[url="http://www.boston.com/dailyglobe2/170/nation/Asthma_drug_has_promise_and_big_price+.shtml"]http://www.boston.com/dailyglobe2/170/nation/Asthma_drug_has_promise_and_big_price+.shtml[/url]

Posted on: Fri, 07/11/2003 - 7:45am
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Xolair will soon be distributed by Genentech to AdvancePCS, which is one of the largest pharmacy providers in the US. Hopefully, the other pharmacy providers will follow. This is so exciting.......

Posted on: Fri, 02/27/2004 - 6:18am
MommaBear's picture
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reraising.

Posted on: Sat, 04/03/2004 - 12:39am
NOPEANUTSALLOWED's picture
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Hello everyone,
I am assuming none of you have read anything, but I am raising this topic again.
Let me know!

Posted on: Sat, 04/03/2004 - 5:51am
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Our old allergist was very supportive, had prescribed it to others, and all insurance was paying. Our Dd is too young, but she thought it was an option for her when she gets older.
Paula

Posted on: Sat, 04/03/2004 - 1:44pm
ajinnj's picture
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There have been MANY threads on this topic. Here is one link to the most recent thread:
[url="http://uumor.pair.com/nutalle2/peanutallergy/Forum1/HTML/004743.html"]http://uumor.pair.com/nutalle2/peanutallergy/Forum1/HTML/004743.html[/url]
You can also do a search to see all the related threads.
Allison

Posted on: Thu, 07/01/2004 - 12:40am
Jana R's picture
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Here's a link listing research locations:
[url="http://www.clinicaltrials.gov/ct/gui/show/NCT00079937?order=1"]http://www.clinicaltrials.gov/ct/gui/show/NCT00079937?order=1[/url]
[i][b]The Efficacy and Safety of Xolair in Children (6 - <12 years) with Moderate-Severe, Inadequately Controlled Allergic Asthma[/b]
This study is currently recruiting patients.
Sponsored by
Novartis Pharmaceuticals
Purpose
This study will look at data collected over 1 year to determine the effectiveness of omalizumab (Xolair) in controlling moderate-to-severe allergic asthma in children 6 to 12 years of age whose asthma is persistent and not well controlled. This study will also evaluate the safety of this treatment in terms of side effects and other clinical and laboratory measures.
Condition Treatment or Intervention Phase
Asthma
Drug: Omalizumab
Phase III
MedlinePlus related topics: Asthma
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: 1-year, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Trial of Efficacy, Safety, and PK/PD of Omalizumab in Children (6 - <12 years) with Moderate-Severe, Persistent, Inadequately Controlled Allergic Asthma
Further Study Details:
This study is designed to provide one year efficacy and safety data for subcutaneous (SQ) omalizumab, compared to placebo in children (6 to < 12 years) with moderate to severe persistent asthma who have inadequate asthma control despite treatment according to NHLBI step 3 or 4 (at least medium dose inhaled corticosteroids with or without other controller asthma medications).
Eligibility
Ages Eligible for Study: 6 Years - 12 Years, Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
outpatient who agrees to written informed consent
male or female of any race aged 6 to 12 years old
body weight greater than or equal to 20 kg (~44 lbs) and less than or equal to 150 kg (~330 lbs)
total serum IgE level equal to or greater than 30 to equal to or less than 1300 IU
diagnosis of allergic asthma equal to or greater than 1 year
positive skin prick test to at least one perennial allergen
equal to or greater than 12% increase in FEV1 within 30 min of taking salbutamol
past medical history of exacerbations
evidence of inadequate asthma symptom control
inhaled corticosteroid dose equivalent to fluticasone DPI equal to or greater than 200 mcg/day
AND
2 exacerbations in the previous 12 months requiring treatment with oral or IV corticosteroids and/or a doubling of the maintenance inhaled corticosteroid dose for at least 3 days
OR
3 exacerbations in the previous 24 months; 1 of which occurred in the previous 12 months (same treatment as above)
OR
hospitalization (including ICU) or received ER treatment (including urgent care centers) in the past 12 months for an asthma exacerbation, as defined by the GINA 2002 guidelines for a severe exacerbation
Exclusion Criteria:
pregnant or breast-feeding
nonadherence to protocol medicaton washouts
treatment with unacceptable concomitant medications
current or past clinically significant uncontrolled systemic disease
current, past, or potential cancers
platelet levels equal to or less than 130 x 109/L at Visit 1
previous treatment with Xolair
unable either alone or with their caretaker to perform spirometry, peak flow measurements or completion of the diary card
history of food or drug-related severe anaphylactoid or anaphylactic reaction(s)
history of allergy to antibiotics
Other protocol-defined exclusion criteria may apply.
Expected Total Enrollment: 570[/i]
------------------
Jana
[url="http://www.seattlefoodallergy.org"]www.seattlefoodallergy.org[/url]

Posted on: Fri, 07/02/2004 - 11:54am
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My daughter's Allergist made it sound like insurance companies were not covering this in general for kids. I looked at the link for the trial mentioned above, and my daughter's pulmonologist is listed...then I read the exclusion factors, you cannot have had a previouse anaphylaxis.
The allergist thinks this would be a great drug for her, he thinks allergy shots are too risky AND we have not been able to control her asthma despite being on the max dose of Advair, double dose of Zyrtec, and Max dose of Singulair she still has to go on oral steroids several times a year.
Sorry didn't mean to turn this into a book.
Penny

Posted on: Tue, 03/02/2004 - 3:02am
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re-raising

Posted on: Tue, 03/09/2004 - 8:13am
Lisa V's picture
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The only place I have heard that it has been approved is in Australia. Anyone else know anything new?

Posted on: Tue, 03/09/2004 - 9:06am
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Quote:Originally posted by Lisa V:
[b]The only place I have heard that it has been approved is in Australia. Anyone else know anything new?[/b]
Xolair was actually approved in the United States this past June. It is used to treat moderate to severe asthmatics who have not responded to traditional therapy.
Allison

Posted on: Tue, 03/09/2004 - 9:31am
ajinnj's picture
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[url="http://uumor.pair.com/nutalle2/peanutallergy/Forum1/HTML/004743.html"]http://uumor.pair.com/nutalle2/peanutallergy/Forum1/HTML/004743.html[/url]

Posted on: Mon, 06/27/2005 - 1:53am
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I just found out that a doctor in my area is conducting Xolair trials. I spoke to the nurse today.
She says they are all set to start Xolair trials for PA but they are having a hard time getting a hospital to work with them. They are working on Children's of LA to get their approval.
She says they initially have to induce and treat anaphylaxis before they start the study. Then periodically during the study period they again attempt to induce anaphylaxis.
I have to call back after January when DS is back from Scotland. They could then try to put him in the trials.
I doubt I could approve of DS doing this though.
The nurse said Xolair is approved for moderate to severe asthma and if we get an IGE level on DS and he qualifies then his insurance will pay for the Xolair for his asthma which will then affect his PA as well.
Something to look into. Sorry if this has been discusssed already, I did a search and did not see specifics to help me.
Peg

Posted on: Wed, 06/29/2005 - 2:20pm
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Sorry, Peg for the long delay in response here. Busy busy busy.
Xolair is approved for use on asthmatics here in Canada. Has been for awhile.
I didn't know about it because the doc figured why tell me? I simply can not afford it and he knew it would upset me. He was right. I am upset about it especially when I know someone in the same boat as my son and she takes Xolair and has cut the episodes in half or more.The hospital stays are almost gone and the time from school is no longer. What I want for my son. Like him nothing worked for her except this.
He will not be getting it. He does not qualify for the study as he is peanut allergic and there are documented anaphalaxis to the peanut. Bummer. They want patients with NO nut allergies at all so that they can do seperate studies. One for asthma and one for peanuts.Same for the peanut one. They want patients without asthma for it. So either way he won't be getting the drug. [img]http://uumor.pair.com/nutalle2/peanutallergy/frown.gif[/img]
If this is such a great drug I think the gov. would be very wise to give it to those in need like they do the flu shot. So much money could be saved by doing that on hospital bills, and ambulance bills. Not to mention time missed due to the illness. Adults and children who of course would fit the bill. SEVERE asthma. Documented ect...
~Jenna

Posted on: Thu, 06/30/2005 - 12:49am
Carefulmom's picture
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Dd`s allergist and I discussed this at length several months ago. Here in Los Angeles, they ARE doing it on people with pa and asthma. Asthma does not disqualify you. However, it is a very risky study, and the exposure to peanut which is part of the study he and I decided was too risky. I know if everyone has my attitude the study will never be done, but I just could not do it. Also, he said the study would probably decrease her chance of outgrowing her pa, with all the exposure to peanuts, so I did not like that.

Posted on: Thu, 06/30/2005 - 1:56am
Peg541's picture
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Thanks for the replies.
I agree with Carefulmom. The study says you have to become anaphylactic in order for the study to start. This is not something we are willing to risk. DS said he would do it but if I have a choice I say no.
We are trying to get his respiratory doc to OK the Xolair IF his IgE is high enough then insurance will pay for it.
Small steps but that's the way it works.
Peg

Posted on: Fri, 07/01/2005 - 4:17am
domesticgodess's picture
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Well,I want it for asthma not PA. They are doing SEPERATE studies for the asthma and the PA.
In the study I wanted into was for asthma only. I could careless about the PA study. He is already anaphalactic to the nuts. His ieg was to high to admit him into the asthma aspect of the study.
Truth be told PA is least of my worries. It is the asthma that is causing the near death episodes. Since it is allergy induced and the allergies causing these episodes are from things I have no control over.
I can not afford this xolair, and the hope was to get it from the study for 2 yrs free of charge. After that we were hoping to find another way to get this for him. But we would have 2 yrs. Its a bummer. As for the PA part of the study it was explained to my son and he wanted to do it. I would have let him but he doesn't qualify as his asthma is to brittle. Its a darn if you do darn if you don't situation.
~Jenna

Posted on: Wed, 07/06/2005 - 5:31am
Carefulmom's picture
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To get information about being in the Xolair study, you can call (888) 662-6728.

Posted on: Wed, 07/06/2005 - 10:53am
domesticgodess's picture
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Would this include Canadians? Is it Canadian? I don't even know if I can get him into a study in the U.S but I am willing to take him there.
~Jenna

Posted on: Wed, 07/06/2005 - 11:06am
Carefulmom's picture
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I don`t know about Canadians. It is worth a phone call to ask, right?

Posted on: Wed, 08/16/2006 - 3:37pm
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For those that are unfamiliar with the story of Tanox and Xolair, here's a recap from the Wall Street Journal
[url="http://uumor.pair.com/nutalle2/peanutallergy/Forum8/HTML/001059.html"]http://uumor.pair.com/nutalle2/peanutallergy/Forum8/HTML/001059.html[/url]
We're not involved with a Xolair study for peanut allergy. I recall that the studies were halted back in January due to safety concerns (2 kids experienced severe reactions)
[url="http://uumor.pair.com/nutalle2/peanutallergy/Forum8/HTML/001405.html"]http://uumor.pair.com/nutalle2/peanutallergy/Forum8/HTML/001405.html[/url]
...I hadn't heard whether the studies had resumed...anyone?

Posted on: Wed, 08/16/2006 - 3:40pm
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According to Genentech's website as of 2/06, the study is still halted as they work with physicians and the FDA to try to figure out how to conduct the clinical trials without putting participants' lives at unacceptably high risk...
[url="http://www.gene.com/gene/pipeline/status/immunology/xolair/index.jsp"]http://www.gene.com/gene/pipeline/status/immunology/xolair/index.jsp[/url]
[This message has been edited by Nutternomore (edited August 17, 2006).]

Posted on: Sat, 10/14/2006 - 12:26pm
2boys2luv's picture
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I just checked in on the Xolair/peanut allergy study about 2 weeks ago. It is still halted!!! The letter I received from Tanox is below. Tanox was the original maker of TNX-901 that was doing amazingly well, only to be halted by greed hungry giants, Genetech & Novartis, and forced to accept Xolair to be the answer instead, which obviously is not working. I can NOT believe that a life saving drug such as TNX-901 can be halted. Isn't there anything we can do about it? Does one arbitrator/judge get to decide the fate of all of our loved ones???
Ms. Trautweiler,
Thank you very much for taking time to share your comments with us. Tanox remains committed to determining if Xolair can be an effective therapy for patients with peanut allergy.
The Phase 2 trial was stopped due to issues associated with the oral food challenge aspect of the screening process, not because of any adverse reactions to Xolair.
We, along with Genentech and Novartis, are continuing to evaluate Xolair. We are all mindful of the challenges faced by peanut allergy sufferers.
Warmest regards,
Steve
Steve Sievert | Tanox Investor Relations & Corporate Communications
Office: 713.578.4211| Fax: 713.578.5211| Mobile: 713.412.0769 | [email]ssievert@tanox.com[/email]
Tanox 20 Years of Discovery :: 1986-2006

Posted on: Sun, 10/15/2006 - 2:45am
Carefulmom's picture
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Someone on this board has a child on Xolair. It is Rebekahc. If you do a search, you will see a lot of posts from her about it.

Posted on: Wed, 08/16/2006 - 3:37pm
Nutternomore's picture
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Joined: 08/02/2002 - 09:00

For those that are unfamiliar with the story of Tanox and Xolair, here's a recap from the Wall Street Journal
[url="http://uumor.pair.com/nutalle2/peanutallergy/Forum8/HTML/001059.html"]http://uumor.pair.com/nutalle2/peanutallergy/Forum8/HTML/001059.html[/url]
We're not involved with a Xolair study for peanut allergy. I recall that the studies were halted back in January due to safety concerns (2 kids experienced severe reactions)
[url="http://uumor.pair.com/nutalle2/peanutallergy/Forum8/HTML/001405.html"]http://uumor.pair.com/nutalle2/peanutallergy/Forum8/HTML/001405.html[/url]
...I hadn't heard whether the studies had resumed...anyone?

Posted on: Wed, 08/16/2006 - 3:40pm
Nutternomore's picture
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According to Genentech's website as of 2/06, the study is still halted as they work with physicians and the FDA to try to figure out how to conduct the clinical trials without putting participants' lives at unacceptably high risk...
[url="http://www.gene.com/gene/pipeline/status/immunology/xolair/index.jsp"]http://www.gene.com/gene/pipeline/status/immunology/xolair/index.jsp[/url]
[This message has been edited by Nutternomore (edited August 17, 2006).]

Posted on: Sat, 10/14/2006 - 12:26pm
2boys2luv's picture
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I just checked in on the Xolair/peanut allergy study about 2 weeks ago. It is still halted!!! The letter I received from Tanox is below. Tanox was the original maker of TNX-901 that was doing amazingly well, only to be halted by greed hungry giants, Genetech & Novartis, and forced to accept Xolair to be the answer instead, which obviously is not working. I can NOT believe that a life saving drug such as TNX-901 can be halted. Isn't there anything we can do about it? Does one arbitrator/judge get to decide the fate of all of our loved ones???
Ms. Trautweiler,
Thank you very much for taking time to share your comments with us. Tanox remains committed to determining if Xolair can be an effective therapy for patients with peanut allergy.
The Phase 2 trial was stopped due to issues associated with the oral food challenge aspect of the screening process, not because of any adverse reactions to Xolair.
We, along with Genentech and Novartis, are continuing to evaluate Xolair. We are all mindful of the challenges faced by peanut allergy sufferers.
Warmest regards,
Steve
Steve Sievert | Tanox Investor Relations & Corporate Communications
Office: 713.578.4211| Fax: 713.578.5211| Mobile: 713.412.0769 | [email]ssievert@tanox.com[/email]
Tanox 20 Years of Discovery :: 1986-2006

Posted on: Sun, 10/15/2006 - 2:45am
Carefulmom's picture
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Joined: 01/03/2002 - 09:00

Someone on this board has a child on Xolair. It is Rebekahc. If you do a search, you will see a lot of posts from her about it.

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Latest Post by mom1995 Fri, 09/06/2019 - 1:52pm
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