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Update for Xiaflex
Auxilium Pharmaceuticals has the rights to a potential new treatment for
Peyronies. They have named this new product Xiaflex and the hope is that it
will reduce the scarring associated with Peyronies. I have been able to get
some additional information about the upcoming testing that I believe is
reliable, but not guaranteed.
There have been a number of delays in the clinical trial’s schedule. Testing
was to begin late in 2007, then in the first quarter of 2008 and now it is
anticipated that it will begin the summer of 2008. The testing procedure is
moving forward and the company has sent the proposed clinical trial protocol
to the investigators who will run the drug trial. There will be multiple sites; at
least 5 different testing centers.
There will be at least 2 screen out criteria. 1) Calcification of the scar tissue
area and 2) Failure to achieve an erection via injection. This criterion makes
sense because calcification or hardening of the area will make it more difficult
for Xiaflex to soften the plaque. Failure to produce an erection indicates
Peyronies and a serious additional erectile dysfunction component. Let’s be
realistic. The purpose of dissolving the plaque and straightening the penis is
so we can engage in sexual intercourse.
Stay tuned. Although there have delays, it is moving forward towards a clinical
trial.
Auxilium Pharmaceuticals has the rights to a potential new treatment for
Peyronies. They have named this new product Xiaflex and the hope is that it
will reduce the scarring associated with Peyronies. I have been able to get
some additional information about the upcoming testing that I believe is
reliable, but not guaranteed.
There have been a number of delays in the clinical trial’s schedule. Testing
was to begin late in 2007, then in the first quarter of 2008 and now it is
anticipated that it will begin the summer of 2008. The testing procedure is
moving forward and the company has sent the proposed clinical trial protocol
to the investigators who will run the drug trial. There will be multiple sites; at
least 5 different testing centers.
There will be at least 2 screen out criteria. 1) Calcification of the scar tissue
area and 2) Failure to achieve an erection via injection. This criterion makes
sense because calcification or hardening of the area will make it more difficult
for Xiaflex to soften the plaque. Failure to produce an erection indicates
Peyronies and a serious additional erectile dysfunction component. Let’s be
realistic. The purpose of dissolving the plaque and straightening the penis is
so we can engage in sexual intercourse.
Stay tuned. Although there have delays, it is moving forward towards a clinical
trial.