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The Real Deal?
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11/16/06 01:52
Randy H.

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11/16/06 01:52
Randy H.

not registered

In for a Penny, In for a Pound

Well, Jim h, maybe AUXILIUM is just all smoke and mirrors, but they've apparently impressed NASDAQ that they've got it going on. When and if subjects are actually injected with AA4500 in a Phase III trial, I think any doubt of their intentions should be removed. To begin a trial and then abandon the subjects by not finishing it would put them in the Dog House with he FDA big time. You have shown us why we should have a level of skepticism, but upon the first report of AA4500 injection, it's a done deal in my mind. No going back.

11/21/06 01:03
Hammer head

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11/21/06 01:03
Hammer head

not registered

Buy

It sounds like a buy to me. Don't run with the herd. Swim upstream. In the words of Big Jim....BUY BUY BUY Ski Daddy!

11/21/06 01:07
The Needle

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11/21/06 01:07
The Needle

not registered

AA4500

Collagenase in the treatment of Dupuytren's Contracture -

Stony Brook University Clinical Trial

This is a continuation on earlier phase studies at Stony Brook where results were promising. In a random, placebo controlled, double blind study, collagenase injection therapy will be investigated for it's ability to lyse the Dupuytren's cord. Resultant cord rupture may obviate the need for patients to have surgery to correct the finger flexion contractures of Dupuytren's disease.

http://indigo.gcrc.sunysb.edu/Factsheet.aspx?ProtocolNumber=0...

11/21/06 01:44
jim h

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11/21/06 01:44
jim h

not registered

why I~sq~m skeptical

I think we all fall into the trap of assuming that if some new drug is show to "work" really well, that means it will become available as a product. Actually, there's only an indirect connection. The real purpose of a company like Auxilium is to make money - a lot of money - if that can best be accomplished by selling the product, great, but if not, the product won't happen.

And as more investors, and investment dollars, are pulled in it becomes necessary for the product to make even more money in order for the big financial picture to work. Unfounded speculation in the company stock can inflage expectations too. Big investors can ultimately force a company to abandon its previous, realistic plans and start forming bigger but totally unrealistic plans that result in a higher "burn rate" of capital, and ultimately sink the ship.

One reason Auxilium's stock was just downgraded is that the "Orphan Drug" status only allows a few years of intellectual property protection - maybe not enough to make the big dollars that Auxilium's investors are now demanding...

11/22/06 01:01
Randy H.

not registered

11/22/06 01:01
Randy H.

not registered

Why I am Skeptical

"AA4500.........has the potential to be the first, effective, non-surgical treatment for patients with Dupuytren's contracture."

Where have these guys been? They didn't happen to notice that Eaton legitimized NA at the last meeting of the ASHS, making their above statement a complete farce?

This press release either contains an outright lie OR complete ignorance of what is going on in the field that they want to enter. I'll admit that, either way, that does not build my confidence.

Meanwhile, my qualification for belief in the project (injection of US patients) has not been met, so I too remain a little skeptical.

11/30/06 01:35
Donald 
11/30/06 01:35
Donald 
Phase III Collagenase Trials

I am considering participating in the Manhattan trials. Would any of you have heard of any risks? Risks from the medication or even risks from the placebo (such as negative effects due to hand being pricked or receiving an injection). Donald

11/30/06 01:30
Randy H.

not registered

11/30/06 01:30
Randy H.

not registered

The Risk

Donald:

The essential risk of Collagenase is that the material could possibly dissolve away tissue other than the diseased Dups tissue: Nerves, Tendons, Muscles. Also, will the material migrate to other parts of the and or body.

The good news is that "so far so good". We have no reports of the Collagenase misfiring. However, the number of subjects yet to be tested in the final Phase III trials will be more than have been tested so far. You would be helping to confirm that AA4500 is indeed safe.

Getting the placebo is of no concern. Whatever minor irritation that might trigger more Dups would be soon countered by the real AA4500. Your other option is NA, which would be far more invasive than an injection of placebo. NA does not seem to trigger more disease.

11/30/06 01:33
Donald 
11/30/06 01:33
Donald 
Phase III collagenase

Randy,
As always, your inputs are so valuable. You are such a wonderful resource. Can't thank you enough for all the information you are providing on this forum.
You mentioned the risks of the collagenase migrating to nerves, tendons, etc. Do you know what the consequences of such migration might be in terms of physical problems? Could the problems be permanent? Is there any reference on that issue?

12/01/06 01:26
Wolfgang

not registered

12/01/06 01:26
Wolfgang

not registered

collagenase

Donald, collagen is an important constituent of your joints. Losing collagen in your joints will increase friction, cause inflamation, and eventually damage your joint. Glucosamine and Condroitin are being used to increase the collagen level in the body to relieve joints (and potentially increase Dupuytren as well but that's another story). If collagenase migrates into a joint it might reduce the collagen there and create trouble. My guess is that this is the reason why collagenase is actually not being used to dissolve major parts of the nodule or cord. Only small amounts of collagenase are used to weaken the cord (as with NA), which is then is mechanically teared apart. These small amounts of collagenase probably won't escape from the cord and won't do damage.

And of course there might also be other side effects of which we are not aware yet. We need to wait for the result of the phase III trial.

Wolfgang

12/01/06 01:30
Donald 
12/01/06 01:30
Donald 
Phase III

Thank you Wofgang for the additional info. My appreciation for Randy in this forum also goes to you. Your comments are not only always informative but also well balanced.

Now to the specific subject of collagenase. You mentioned "Only small amounts of collagenase are used to weaken the cord (as with NA), which is then mechanically teared apart." Are you saying that the collagenase injection method uses larger and therefore potentially unsafe amounts? This brings me to my second question. Since these are Phase III trials, would this not mean (by definition of a Phase III clinical trial) that the issues of safety have been put to rest and that they are now testing for efficacy, not safety?

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