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.

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...

"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.

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.

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