Earth to Jay. Earth to Jay....Come in Jay. You started this thread on 8/6/2004. What's up Jay? What has happened at Stanford?

I also met with Dr. Vincent Hentz several years ago and was accepted into the trials which still haven't been scheduled. I had a nice conversation with Dr. Hentz who told me it was always apparent whether the patient had received the collagenase and which had received the placebo. The first day the patient was injected --and as I recall there was NO anaesthesia used-- and on the second day, the patient returned for flexing and stretching of the hand. He said that they were always able to stretch the hands of patients that received collagenase and there was no change on those that received the placebo. The bad part of the study was that one had a 50/50 chance of receiving the placebo although if one had, they did offer a second injection outside the trial, that was guaranteed collagenase.

I opted for Dr. Eaton last month and am completely satisfied--in fact, ecstatic might be a better word. I hope collagenase will be approved if I ever need further treatment but if not, I'll happily return to Dr. Eaton.

Not a peep re: Phase III. I would assume it is a dead issue.

Collagenase is a drug and requires FDA approval. NA is just a procedure. That's why we have NA and not Collagenase.

BioSpecifics licensed the rights to Auxilium. Auxilium claims they're starting trials for Peyronie's. Whether they actually intend to get approval and produce the product, or just use the patent to attract investment cash year after year, remains to be seen.

If the FDA approves it for Peyronie's, it might be used off-label for Dupuytren's.

Tolucca,

There are a couple of reasons why the trials for DD might never be completed.

Sometimes a patent can bring in more money as 'investor bait' than it would as a real product. Having a 'promising' product perpetually in the R&D 'pipeline' is a classic technique used by startup companies to pull in millions of dollars in new investment - which is turned into salaries, bonuses and travel expenses, while the product never seems to get to completion. I can't really accuse BioSpecifics of this, but one could reach that conclusion just looking at the bare facts over the last several years.

Although injectable Collagenase was developed for DD, it may also be effective against Peyronie's and Lederhose diseases, where surgery is a poor choice and NA won't work at all. Auxilium was primarily interested in the market for Peyronie's disease and may or may not be interested in completing the trials for Dupuytren's, which were started by BioSpecifics.

The increasing acceptance of NA in the U.S. may have caused a change of direction at Auxilium.

It's also possible that the results of the trials to date haven't been good enough to justify completing them.