Auxilium Pharmaceuticals, Inc. Receives Clearance to Resume Clinical Trials for XIAFLEX(TM)
Auxilium Pharmaceuticals, Inc. (Nasdaq: AUXL) today announced that the Company has received clearance from the U.S. Food and Drug Administration ('FDA') to resume its phase III clinical trials for XIAFLEX (clostridial collagenase for injection), formerly referred to as AA4500, in the treatment of Dupuytren's contracture.
... The Company plans to initiate a pivotal double-blind trial in the U.S., a double-blind trial in Australia, and two open label trials that along with previously conducted trials will serve as the basis for the Biologics License Application ('BLA') for marketing approval from the FDA....
... Auxilium has four projects in clinical development. XIAFLEX(TM) (clostridial collagenase for injection), formerly referred to as AA4500, is in phase III development for the treatment of Dupuytren's contracture and is in phase II development for the treatment of Peyronie's disease and Frozen Shoulder syndrome (Adhesive Capsulitis).
Sunday, August 19, 2007
Clostridial Collagenase treatment for Peyronie's, Dupytren's and Frozen Shoulder syndrome
I usually don't pay attention to press releases on clinical trials -- they're fishing expeditions for investors and/or speculators. This one caught my eye because of the focus on several diseases of pathologic fibrosis:
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4 comments:
You wrote about Auxilium Pharmaceuticals. They are about to begin their phase II drugs trials. Do you have any advice, suggestions, comments for someone who is considering participation in these drug trials?
When considering a clinical trial you must remember that the purpose of the trial is not to help you, it is to learn things.
So your primary motivation should be altruistic -- to advance learning. If you're participating in the trial primarily to get the latest treatment you're making a mistake.
This means you have to be comfortable with getting a placebo treatment. It also means you have read the risks carefully, and believe that they could happen to you.
We need clinical trials, so if you want to do this to advance understanding of Peyronies, and you've read the risks carefully, we can all benefit.
Just don't do it as a way to get a new treatment early.
FYI - Testing with Xiaflex is about to begin in the next few days. Although I am somewhat puzzled that there is nothing on the clinicaltrials.gov website.
I have been preliminarily diagnosed with peyronies, at least a plaque that is causing some problems with erection. I am very interested in being treated with collagenase, and want to know where available at present (which clinic) and if not, when and where it will be available.
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