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AUXILIUM PHARMACEUTICALS

As I am sure most of you are aware, Auxilium Pharmaceuticals is a
specialty drug company that is developing Xiaflex (collagenase) for the
treatment of Dupuytren's Contracture (DC) and Peyronies Disease (PD).
Xiaflex has been submitted to the FDA for final approval for the treatment
of DC and a decision is expected in the next few months. Testing for PD is
at Phase IIb and final approval is some way off.  Although, if approved for
DC, urologists would most likely offer Xiaflex for the off label use in the
treatment PD.  Both these conditions involve collagen disorders, but affect
two distinct organs of the body; the hand vs. the penis.  So the issue is
whether Xiaflex will have a similar effect on collagen tissue in both organs
of the body and will there be any adverse side effects.  There are
encouraging findings from recent in vitro testing done on tissue samples
from PD and DC plaque.  

PD plaque and DC cord tissue samples were removed from patients
undergoing corrective surgery.  Samples were injected with Xiaflex and
then the collagen fibers were examined.  The good news is that Xiaflex
effectively degraded both PD plaque and DC cord tissue without any
observable toxicity or structural damage to the non collagenous tissue
elements.  (The Journal of Urology, vol 181, No.4, Supplement, Monday,
April 27, 2009, page 279).

Hives, No Problem.  At a recent conference, the CEO of Auxilium was
asked if Xiaflex injections resulted in hives or any other allergic reaction.  
His response was that local reactions do occur in some instances.  He
believes that this is a result of the drug action and the breakdown of the
collagen core.  More common are reactions such as swelling, redness and
bruising.   Another company official added that these reactions occur
independent of which injection the patient receives. (I assume he means
Xiaflex vs the placebo). My response is  this is a small price to pay for an
effective treatment.  This is all very minor.  

One aspect that is not minor is the way the website that published this
article portrayed PD.  They had the obligatory, immature, bent pipe to
introduce the story.  Get it, penis a man's pipe, bent, ha, ha. Xiaflex was
described as the "unlikeliest drug in Pfizer’s pipeline" (Pfizer has a
business arrangement with Auxilium).

DC – as Xiaflex moves forward as a treatment for DC we are beginning to
see a number of articles and internet video posting from patients’ with DC
who have underdone treatment with Xiaflex.  
Click on a very positive video
about a female pianist who was pretty much cured after Xiaflex injections.
Hopefully. We can share the same experience if it becomes available to
treat PD.

                                                                
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