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AA4500 sucessfull phase 3 trial - webcast
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05/30/2007 04:00
Mark_D 
05/30/2007 04:00
Mark_D 
Re: AA4500 sucessfull phase 3 trial - wecast

Chris:

Thanks for your clarification.

Your restatement seems closer to what the guys-in-the-know on this site have been saying.

But, it still seems to me that we're dealing with a gray area.

Mark

05/30/2007 13:40
jim_h 
05/30/2007 13:40
jim_h 
Re: AA4500 sucessfull phase 3 trial - wecast

I'm sure that collagenase has the potential to cause damage. However, remember that with surgery, collateral damage is a certainty - the surgeon has to cut through good tissue to get to the bad. I have scar tissue, a frozen joint and nerve damage as mementos of 2 conventional surgeries.

05/30/2007 17:30
Randy_H 
05/30/2007 17:30
Randy_H 

Re: AA4500 sucessfull phase 3 trial - wecast

The ex-president of the ASSH was scheduled to head a Phase III trial of Collegenase Injections (CI) at UCLA, and he still may if the money finally arives through Auxilium. I was on his waiting list to be a participant in 2003 when BioS could not fund the project. Darn! Not being aware of NA I had OS instead when my PIP reached 45 degrees. It was the opinion of this particular CHS that Collegenase was still so untested that having OS may have been the better choice, which is to say he is still skeptical. We need completion of Phase III to prove this stuff is safe and effective. As we know, so far CI has caused *no* collateral damage whatsoever and has a success rate equivalent to NA.

I'm conflicted. As a staunch NA advocate I have written extensively on it's defense on the BioS forum and here. If I, and others like me, were to achieve our goal of NA's vindication and acceptance into common use, that could reduce the chance of CI ever seeing the light of day. That would be an unfortunate outcome as I believe CI may have the potential to be more effective in some cases than NA. I guess just like Auxilium I must rely on the intransigence of most CHS who simply will *not* cut what they can't see. This regardless of Eaton/Denkler's stellar work and accomplishments showing NA is far safer than OS :-) Go Figure.

05/30/2007 21:48
Chris

not registered

05/30/2007 21:48
Chris

not registered

Re: AA4500 sucessfull phase 3 trial - wecast

In reponse to Jim's comments,

Yes my surgeon did say that nurve damage is a possibility on the second and latter sugeries. This was mainly because scar tissue can become interweaven with the nurve after the first surgery. He also said that of the thousands of patients he has operated on for this condition only 5 have nurve damage. He has never given any patient nerve damage on the first surgery.

It does seem that from these results Jim is one of the rare and unlucky cases.

Surgery is proven to have the lowest recurence rate of all the techniques and is said (in the opinion of my surgeon) to be the best option for patients who are younger (<55 years old) and have more aggressive forms of the disease. N.A is a good option, if you have access to it, are in the older age group and therefore not as concerned with recurrence and someone in the younger age group. Older people also tend to have less aggressive contractures and therefore will require less time between treatments of N.A.

The current treatment that has the lowest recurrence rate (<10%) is skin the graft procedure. This applies only to patients that have quite pronounced dupuytrens contracture. Radiation treatment might (although don't quote me on this) have lower recurrence rate for patients who have caught the disease in the early stage and have less aggressive Dupuytrens.

05/30/2007 22:34
Chris

not registered

05/30/2007 22:34
Chris

not registered

Re: AA4500 sucessfull phase 3 trial - wecast

In reponse to Jim's comments,

Yes my surgeon did say that nurve damage is a possibility on the second and latter sugeries. This was mainly because scar tissue can become interweaven with the nurve after the first surgery. He also said that of the thousands of patients he has operated on for this condition only 5 have nurve damage. He has never given any patient nerve damage on the first surgery.

It does seem that from these results Jim is one of the rare and unlucky cases.

Surgery is proven to have the lowest recurence rate of all the techniques and is said (in the opinion of my surgeon) to be the best option for patients who are younger (<55 years old) and have more aggressive forms of the disease. N.A is a good option, if you have access to it, are in the older age group and therefore not as concerned with recurrence and someone in the younger age group. Older people also tend to have less aggressive contractures and therefore will require less time between treatments of N.A.

The current treatment that has the lowest recurrence rate (<10%) is skin the graft procedure. This applies only to patients that have quite pronounced dupuytrens contracture. Radiation treatment might (although don't quote me on this) have lower recurrence rate for patients who have caught the disease in the early stage and have less aggressive Dupuytrens.

05/30/2007 23:09
Randy_H 
05/30/2007 23:09
Randy_H 

Another View

The occurrence of nerve damage from OS is dependent on which joint is being corrected. The MCP, closest to the palm, is subject to far less danger than the PIP, especially the pinkie. I was told pre-op that there "was a chance" of nerve damage. Sure enough, I have permanent nerve damage. This in contrast to the correction of another PIP with NA. Sure enough, no nerve damage. However, I certainly could tell when the needle was close to a nerve and spoke up *immediately*, probably saving me the same fate as my earlier OS. That's how NA works. The patient gives the surgeon the necessary feedback to avoid damage. The surgeon then comes from a different angle and gets the job done. Snap goes the cord.

Those who experience unacceptable rates of recurrence after NA should, in my view, go straight to the skin graft. The rate of recurrence between NA and the standard Open Surgery is not significant enough to use standard OS it as an intermediate step. However, the upcoming published five year NA recurrence data form Eaton will tell the tale. Anything else is just a guess. However, I see no reason one should not start with NA and see what the results are. The truncate and operating table are *always* there as a backup, along with months of painful hand therapy. No thanks.

05/30/2007 23:35
jim_h 
05/30/2007 23:35
jim_h 
Re: AA4500 sucessfull phase 3 trial - wecast

Getting back to Auxilium's statements - the stated price of $5,000 is just more hype aimed at investors. Every venture startup claims their product has a huge potential market and will command a premium price. If and when the product is ever produced, the market determines a price at that time. Or I should say, the insurance companies will decide what they're willing to pay.

For now, I would not be holding my breath waiting for AA4500. The endlessly on-and-off trials were stopped early this year - and right on schedule, another analyst jumps in and "initiates coverage", essentially calling the stoppage a golden opportunity for investors:

http://www.newratings.com/analyst_news/article_1539751.html

So the trials are back on hold while Auxilium works the "investor conference" circuit and another round of new money is pulled in. Maybe the trials will be restarted later this year, or maybe not.

05/31/2007 02:07
DianeS 
05/31/2007 02:07
DianeS 
more of another view

Chris reports his surgeon advised that open surgery may be better for those under age 55 due to higher chance of reoccurrence for those with younger onset. While we all know that this is the standard advice of non-NA hand surgeons, it ignores one important piece of information - that for some people surgery triggers a fast and worse recurrance. And after surgery NA may a less viable option due to scar tissue. We also know that you can only do open surgery on a location a few times before the site becomes pretty beat up and nerve damage or other problems occur. Or worse, no more surgery is possible and the digit becomes so bent that amputation is necessary.

So i still don't get the logic that younger people should not try NA first. If you get the disease young you probably will get more of it and why not keep repeating the NA rather than spending thousands for a scarred hand with fewer treatment options. My dups is recurrent and having had both OS and NA, i will take the NA any day. Right on Randy.

05/31/2007 03:18
Chris

not registered

05/31/2007 03:18
Chris

not registered

Re: AA4500 sucessfull phase 3 trial - wecast

Hello,
I don't want this to get into an argument, because all I am doing is reciting more or less word for word what I was told by my surgeon. Yes he is a hand surgeon who only does open surgery, but it was his opinion that a primary treatment of standard open surgery, followed by a skin graft, if the first surgery is not successful is the best course of treatment. He was well aware of the other types of surgeries and I discuss them in depth with him.

I would also suggest that the purpose of this forum is to give people advise and not exageration. It is not (for the vast majority of patients) months of painful rehabilation, especially for young patients who heal more quickly. A hand surgeon would say the rehabilitation for patients under 55 years old would be moderatly painful for the first week and after that gradually subside which I would say from experience is about right. For older patients it might take a bit longer, but certianly not months of painful rehabilitation.

I also never said patients should not get N.A before open surgery. All I said was that this was not the advise given to me by my surgeon. You are free to get N.A if you would like it, but statistically you are more likely to have the disease come back again. For me, as a 28 year older who has already had one surgery, I can see that no amount of N.A is going to help me - there are just too many nodules and lumps. I need to have tissue physically removed from my hand.

I would also say that of all the Dupuytrens surgeries my surgeon has performed (he reckoned thousands), he has only ever amputated once and that was for a patient who was requesting amputation rather than out of absolute nessecity.

As I have already said in the past if your contractures are minor then N.A might be a good option.

I think another thing to remember about this forum is that what you have experienced with either N.A of O.S is not nessecarily the norm. We should not push our opinion of one surgery over another based on our individual experience. Opinions should be given by surgeons, and based of statisical evidence. Our experience of what happened to us, in our individual cases, should only be used to give others an idea of what can happen - not what will happen!

05/31/2007 05:11
Wolfgang

not registered

05/31/2007 05:11
Wolfgang

not registered

Re: AA4500 sucessfull phase 3 trial - wecast

Chris, I think you've got a point there. For the majority of people surgery works out well and thus is a valuable therapy. There are also many cases, specifically in the late stage, where surgery is probably the only option left. If you read through the web site of this forum, www.dupuytren-online.info, you will find the same position, including your comments about skin grafting. But we also need to keep in mind that for some patients surgery might make things worse, even if nothing is damaged accidentially. Basically surgery, NA, and radiotherapy have their virtues and the patient, together with his doctor, should make their own, informed decision. What we are trying to achieve to spread information. Every doctor knows about surgery (though some not much about its risks), very few know about NA, and even less about radiotherapy. That's probably the reason why this forum has more emphasis on the latter.

Wofgang

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