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A MEDICAL BREAKTHROUGH OR FALSE HOPE?
If you have Peyronies Disease this is a must read! First some background.
Peyronies is primarily a scar tissue disease and the main component of scar tissue
is collagen. A company by the name of Biospecifics (or one of its predecessor
companies) developed a process to produce purified collagenase. Collagenase is
an enzyme with the hoped for ability to digest collagen and therefore, reduce
scarring. This collagenase product has been around since at least since the
1980's. For example, in 1982 and 1985 there are articles in the Journal of Urology
discussing it as a treatment for Peyronies. For a number of reasons this company
never moved forward with this product. As best as I can determine, it did not have
the finances to enter the necessary testing to meet regulatory requirements and
there was difficulty in determining how to measure successful treatment. In June
2004, this company entered into an agreement with Auxilium Pharmaceuticals, Inc.
whereby it was granted a license to develop injectable collagenase. Auxilium has
renamed its product XIAFLEX and their web address is http://www.auxilium.com/
As the reader maybe aware, Peyronies is related to a number of other collagen
impairments such as Dupuytren's Contracture. Collagen nodules form in the palm
and ultimately result in a condition where one or more fingers contract toward the
palm. Ultimately, it restricts the individual’s ability to open their hand resulting in a
restriction of daily activities. Results of a double blind placebo controlled study were
published in the July-August 2007 issue of the Journal of Hand Surgery and
indicated general success. Twenty-three patients received injectable collagenase
and 21 had their contraction significantly reduced. No patients who received the
placebo achieved clinical success. The mean number of injections needed to
achieve clinical success was less than 2 and the mean treatment time was 8 days.
The recurrence rate for symptoms was under 10%. The most common adverse
events were pain and swelling. No nerve of artery damage was reported. According
to the company, over 1300 patients have been injected for various conditions and it
appears that XIAFLEX is relatively safe.
In October 2006, it was reported that a small study of XIAFLEX treating men with
Peyronies resulted in significant improvement with no serious adverse reactions.
Auxilium is about to start a double bind placebo controlled study of its drug for
Peyronies very soon. Based on what I can determine, the trial will begin no later
than 30 June 2008 and that actual recruitment should begin shortly. If you are
interested in participating in the trial go to their web site or register at
clinical trials.gov
Let's examine some of the positives and negatives of this approach to Peyronies.
The positives are:
There are some negatives to be considered
If you have Peyronies Disease this is a must read! First some background.
Peyronies is primarily a scar tissue disease and the main component of scar tissue
is collagen. A company by the name of Biospecifics (or one of its predecessor
companies) developed a process to produce purified collagenase. Collagenase is
an enzyme with the hoped for ability to digest collagen and therefore, reduce
scarring. This collagenase product has been around since at least since the
1980's. For example, in 1982 and 1985 there are articles in the Journal of Urology
discussing it as a treatment for Peyronies. For a number of reasons this company
never moved forward with this product. As best as I can determine, it did not have
the finances to enter the necessary testing to meet regulatory requirements and
there was difficulty in determining how to measure successful treatment. In June
2004, this company entered into an agreement with Auxilium Pharmaceuticals, Inc.
whereby it was granted a license to develop injectable collagenase. Auxilium has
renamed its product XIAFLEX and their web address is http://www.auxilium.com/
As the reader maybe aware, Peyronies is related to a number of other collagen
impairments such as Dupuytren's Contracture. Collagen nodules form in the palm
and ultimately result in a condition where one or more fingers contract toward the
palm. Ultimately, it restricts the individual’s ability to open their hand resulting in a
restriction of daily activities. Results of a double blind placebo controlled study were
published in the July-August 2007 issue of the Journal of Hand Surgery and
indicated general success. Twenty-three patients received injectable collagenase
and 21 had their contraction significantly reduced. No patients who received the
placebo achieved clinical success. The mean number of injections needed to
achieve clinical success was less than 2 and the mean treatment time was 8 days.
The recurrence rate for symptoms was under 10%. The most common adverse
events were pain and swelling. No nerve of artery damage was reported. According
to the company, over 1300 patients have been injected for various conditions and it
appears that XIAFLEX is relatively safe.
In October 2006, it was reported that a small study of XIAFLEX treating men with
Peyronies resulted in significant improvement with no serious adverse reactions.
Auxilium is about to start a double bind placebo controlled study of its drug for
Peyronies very soon. Based on what I can determine, the trial will begin no later
than 30 June 2008 and that actual recruitment should begin shortly. If you are
interested in participating in the trial go to their web site or register at
clinical trials.gov
Let's examine some of the positives and negatives of this approach to Peyronies.
The positives are:
- The current research is promising and certainly seems worth trying before
surgery - No serious adverse actions which can be attributed to the medication have
been reported - If you are in the study and get the placebo, the company will treat you with
XIAFLEX after study results are in - Based on prior use of the drug, it appears treatment will be short term
- The stock of Auxilium is rising which indicates at the very least an absence of
bad news concerning the company
There are some negatives to be considered
- Something just does not seem 100% right with the collagenase story. The
drug has been around for at least 20-25 years and supposedly not developed
primarily due to financial concerns. At best, it seems close to a miracle drug
and one would think someone or company would have developed it along time
ago. This lag in time just doesn't sit right with me - An article in the publication European Urology, June 2006 titled “A Critical
Analysis of Nonsurgical Treatment of Peyronie's Disease" does mention the
use of collagenase. After reviewing the evidence, the author concludes that
collagenase does not seem to be an appropriate substance for the treatment
of Peyronies. At most, this treatment might be appropriate for individuals with
only small plaque and minor deformity. This is a thorough and well
documented article - If you are unable to stand a series of injections in you penis, this treatment is
not for you. - There is always a possibility of an unforeseen, serious adverse event. The
penis is not the hand and probably more sensitive - Participants will have to arrange for their own travel and accommodations
- Even if the drug passes this phase, it is no guarantee that it will eventually
make it to market