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Collagenase - where is it available?
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07/23/07 19:49
JulieH 
07/23/07 19:49
JulieH 
Collagenase - where is it available?

I'm very interested in pursuing the collagenase therapy. Does anyone know how to get into the clinical trial, or if this treatment is available outside the US?

07/23/07 20:05
Wolfgang

not registered

07/23/07 20:05
Wolfgang

not registered

Re: Collagenase - where is it available?

Some selected clinics outside the US participate in the collagenasew trial, e.g. I am aware of one in Germany and one in Switzerland. That's the good news. The bad news is that the trial is currently on hold due to production problems. It still might make sense to search for a participating clinic and get wait listed there.

Wolfgang

07/28/07 11:02
newman 
07/28/07 11:02
newman 

Re: Collagenase - where is it available?

Hi Australia Calling.I have recently read that Auxillum Pharmaceuticals Inc are running a trial for AA4500 (Collagen ),being sponsored by BioSpecifics Technologies Corp.They are running a second Phase 3 trial on 200 persons in l5 sites in the US as well a trials on 60 persons in Australia and Switzerland . These trials are for Dupuytren's Contracture. Is this different to Collagenase.

07/28/07 11:52
wach 

Administrator

07/28/07 11:52
wach 

Administrator

Re: Collagenase - where is it available?

Not really. BioSpecifics originally developed and tested collagenase for treating Dupuytren. They then sold the rights to Auxilum who came up with the brand name AA4500 and will eventually conduct the phase III trial, once their manufacturing is up to speed again.

Wolfgang

Quote:



... AA4500 (Collagen ),... Is this different to Collagenase?


08/19/07 18:34
Donald 
08/19/07 18:34
Donald 
Re: Collagenase - where is it available?

Auxilium have announced they will resume collagenase clinical trials within the next 30 days. More info is on their website. The announcement is on the following page
http://ir.auxilium.com/phoenix.zhtml?c=1...1212&highlight=
Donald

08/20/07 07:53
DianeS 
08/20/07 07:53
DianeS 
Why collagenase is better

I recently emailed Dr. Denkler with a question I had been curious about for some time:

If NA and collagenase (now called Xiaflex) do the same thing, why is Xiaflex better or is it?

Here is what he answered:


... PIP joints are tougher with NA. I think Xiaflex holds great promise for PIP joints. NA works very well for MCP joints. Xiaflex will probably do well at the MCP joints also.

I favor Xiaflex because it removes a segment of Dupuytren's. This should lessen recurrence. Open surgery removes a section also, at the price of a more difficult recovery for the patient.
NA only separates the affected cords of Dupuytren's. The cords can rejoin, although this is more of a problem at the PIP joint.
Xiaflex should have recurrence rates approaching open surgery with much more safety and much less recovery. I like the thought of removing the disease with chemical dissolution.
My recommendation is to have NA now and save the finger for the enzyme in the future. I think dissolving all the scar, and any recurrent Dupuytren's will turn out to be much more difficult after open surgery.

Link:

Hand Surg [Am]. 2007 Jul-Aug;32(6):767-74.Click here to read Links
Efficacy and safety of injectable mixed collagenase subtypes in the treatment of Dupuytren's contracture.
Badalamente MA, Hurst LC.

Department of Orthopedics, State University of New York at Stony Brook, Health Science Center, Stony Brook, NY 11794-8181, USA. mbadalamente@notes.cc.sunysb.edu

PURPOSE: To further evaluate the efficacy and safety of an injectable mixed subtype collagenase for the treatment of Dupuytren's contracture (DC). METHODS: Patients with flexion deformities of the metacarpophalangeal (MCP) and/or the proximal interphalangeal (PIP) joints of 20 degrees or greater were randomized in a double-blind, placebo-controlled trial. Patients completing this phase could enter an open-label extension phase. The primary efficacy variable was clinical success: contracture correction to within 5 degrees of normal (normal, 0 degrees ). Additional efficacy variables included the time and number of injections required to achieve success in the primary joint. Recurrence of contracture to 20 degrees or greater in successfully treated joints and adverse events (AEs) were recorded. RESULTS: Thirty-three of 35 patients (mean +/- SD, 61 +/- 9 y) entering the double-blind phase completed the study; 19 of them entered the open-label extension. In the double-blind phase, clinical success of the primary joint was achieved in 16 of 23 patients receiving 1 injection and in 21 of 23 patients receiving 3 injections. No placebo-treated patients achieved joint correction. In the open-label extension, 17 of 19 patients achieved clinical success in at least 1 joint. The mean number of injections for clinical success in the double-blind and extension phases was 1.5 and 1.4, respectively; the time to clinical success ranged between 1 and 29 days. Overall, of 62 joints (31

09/08/07 20:56
3dfleming 
09/08/07 20:56
3dfleming 
Re: Collagenase - where is it available?

I have basic questions...
Is AA4500/Xiaflex the only collagenase suitable for DC?
Or is it the only one being evaluated?
Douglas

09/10/07 22:54
homeboymi 
09/10/07 22:54
homeboymi 

Re: Collagenase - where is it available?

I was just diagnosed with Dupuytren's Contracture today. I have a dimpled lump on my palm but my fingers are not bent. How do I go about applying for the collagenase injection trail? I checked the companies web site but no contact for this. Thanks

09/11/07 02:40
Randy_H 

Moderator

09/11/07 02:40
Randy_H 

Moderator

Re: Collagenase - where is it available?

homeboymi:

"How do I go about applying for the Collegenase injection trail? How do I go about applying for the Collegenase injection trail?"

Unless you have a contraction you would not qualify for the trial. In any case there are no trials underway at this time pending a need for more private funding. Collegenase is years away at best. Until then NA is the only alternative to full open surgery. NA and Collegenase are actually very similar.

09/12/07 02:10
bstenman 
09/12/07 02:10
bstenman 
Re: Collagenase - where is it available?

The problem with the trials is that the USA company licensed to produce the product has subcontracted with two different companies that failed. As a result there has not been sufficient quantities of the product for the trials. The USA company announced earlier in the year that they decided to build their own production facility.

If all goes well the trials might get underway in 2009 and FDA approval in 2010. As Dupuytren's is progressive I have opted for x-ray treatment.

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available   fingers   Pharmaceuticals   metacarpophalangeal   clinical   Dupuytren   Collagenase   treatment   Collegenase   double-blind   Xiaflex   1212&highlight=   Patients   placebo-controlled   Contracture   injection   surgery   participants   interphalangeal   injections