This was in Tanox\'s quarterly report

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In May 2002, we completed a double blind, placebo controlled Phase 2 clinical trial in TNX-901 to evaluate its safety and efficacy in patients with severe peanut allergy. TNX-901 is a humanized anti-IgE monoclonal antibody distinct from Xolair. The trial involved 84 patients in 4 dose groups, (0, 150, 300, and 450 mg). The primary endpoint, based on an increase in symptom threshold to peanuts by oral food challenge, was met with statistical significance. Following receipt of a ruling from an arbitration panel that Tanox does not have the right to independently develop TNX-901, Tanox has suspended its plans to further develop the drug independently (See Note 8).

In October 2002 it was ruled that Tanox has to collaboratively develop this drug with Genentech. Does anyone have information about Genentech's intention of pursuing Phase III clinical trials?

Judy

On Nov 10, 2002

Quote:

Originally posted by JudyH: [b]In May 2002, we completed a double blind, placebo controlled Phase 2 clinical trial in TNX-901 to evaluate its safety and efficacy in patients with severe peanut allergy. The trial involved 84 patients in 4 dose groups, (0, 150, 300, and 450 mg). Judy [/b]

To all 84 patients who participated - God bless them all for helping to bring this peanut allergy nightmare alittle closer to an end. It may not be a cure, but it seems to be the next best thing.

[This message has been edited by Syd's Mom (edited November 10, 2002).]

On Nov 10, 2002

There has actually been a potential bump in the road of Tanox persuing its fast track. Here is the following: (off their website under News. This was mentioned By Dr. Young at the talk he gave in MA last week.) [img]http://uumor.pair.com/nutalle2/peanutallergy/frown.gif[/img]

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This legal action and proceedings could end up holding things up. Such a litigious world. All about the $$$. becca

[This message has been edited by becca (edited November 10, 2002).]

On Nov 11, 2002

When this press release was emailed to me last month, I thought it meant that since Tanox would work with Novartis on this that things would not be held up, since they would be working together on it. Am I wrong?

On Nov 11, 2002

Sounds like a bunch of red tape to me. I will be grateful if they get this stuff on the market before my son (age 7) reaches high school.

On Nov 12, 2002

CarefulMom - I was, and still am, under the same impression as you . . . they will all work together. The founder of Tanox has peanut allergy. I think she wants this completed as much as we all do. I just wonder what we all can do to help out and push it along?

On Nov 12, 2002

Wow, I didn't know the founder of Tanox has an allergy. Interesting. Well, I asked Tanox to let me know if there is anything I can do but they haven't responded. If they do, I'll certainly let you guys know.

On Nov 12, 2002

I don't know if they are working together on this. Tanox was working alone. Now they are not allowed to. When you check the websites of Novartis and Genentech there is no mention of peanut allergy.

Judy

On Nov 12, 2002

Lets hope that the fact that others are trying to get a piece of the action ($$$) that it seems very likely that it works and that it is close to being ready!

That is about the only positive spin I can put on the delay.

On Nov 12, 2002

I just saw that this topic has been addressed on the "Research" Board. Heather2 posted that she received an email from Tanox that the trials on the Tanox 901 have been halted. Very discouraging.

On Nov 17, 2002

My DS' allergist/immunologist said that there are no tests being conducted with children, and until that happens, this will not be available for children because they won't know the proper dosage.

He wasn't telling us to sign up for the trial or anything--he just said that until parents feel comfortable with their children being a part of this research that children won't benefit from it.

Talk about a rock and a hard place.

On Nov 18, 2002

Jackson's Mom...What I have been told is that once it is approved, it will not be FDA approved for children under 12, however, that doesn't mean that there aren't doctors out there who will prescribe it to our children, even though it is not FDA approved. I don't think health insurance will cover it, though. We will have to pay out of our own pockets.

On Nov 19, 2002

I know that our allergist is willing to do it as young as age 7 (my daughter`s age). I don`t know if he is willing to do it in younger kids, since that wasn`t relevant for us. It is beginning to seem that by the time it is available for the public, our kids will all be over 12 anyhow!

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