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This Document

The text in this document is opinion derived from conversations with physicians, biochemists, and other researchers. The photos that appear here are from the Phase 3 clinical trial where a patient was injected with collagenase / xiaflex by Auxilium Pharmaceuticals.

Auxilium collagenase peyronies disease xiaflex

True or False
1. The Auxilium version of collagenase is selective for scar tissue only. It will not dissolve blood vessels. It will only dissolve scar tissue. False. As shown clearly in photos, collagenase dissolves blood vessels (e.g., capillaries in the skin). Dissolving capillaries causes blood to overflow into the skin, forming sacs filled with dark, oxygenated, blood (blood blisters in photos). This happens within minutes of injection, and it can lead to permanent scarring once the blistered skin peels off. In early studies, which may not even be published, dogs that were injected with collagenase bled to death because their blood vessels were destroyed and could not be repaired by the dogs own bodily processes (essentially, their arteries and/or veins were dissolved by this chemical no animal is capable of repairing this kind of damage).

2. The collagenase molecule, once injected, will be able to move through the plaque and dissolve it. False. Collagenase (as a molecule) is huge and collagen molecules are huge. Injecting a tiny amount of collagenase into a collagen plaque in Peyronies disease will only dissolve the scar tissue in a tiny area around the injection site. The collagenase molecule simply is not able to move through a collagen plaque due to the size of the molecules. Once the enzyme (collagenase) binds to its substrate (collagen), it doesnt keep going very far.

3. Collagenase is the enzyme responsible for tissue destruction in gangrene. True. You are essentially causing gangrene of your own penis by allowing yourself to be injected with collagenase. Its a controlled gangrene but it is the same enzyme. It is isolated from bacteria, not animal sources. It is no different than botox in this regard, which is considered safe. However, botox has far fewer side effects to achieve the drug benefit.

4. Collagenase does nothing to restore elastin, which has also been destroyed by Peyronies disease plaques. True. In lucky patients, it will dissolve some collagen scar tissue. However, the elastin that existed in the tunica albuginea before the disorder started is certainly not restored by an enzyme that destroys collagen.

True or False
5. Hourglass deformities (localized narrowing) of the penile shaft can be treated by collagenase. Unknown. Auxilium deliberately refused to enroll people with hourglass deformities in the study so that they would have more positive results in the end. There is no way to know if an hourglass deformity will be helped by collagenase. However, once the drug is approved for Peyronies disease, it will probably be used for hourglass deformities by patients with no other options.

6. The best way to inject collagenase is in a line perpendicular to the penis, directly into the scar tissue. Unknown. All patients are different. Also, collagenase will not go very far beyond the area where it is injected into. So, a perpendicular line may only result in a mild benefit IF the plaque happens to be susceptible to injections made in that pattern. Injecting the substance vertically would risk needle injury to the neurovascular bundle in a dorsal plaque. However, multiple small injections or diagonal injections may be more beneficial.

7. All patients should receive the same dose of collagenase, regardless of plaque size or penis size. These doses are uniformly supplied in powder form to the physician. Questionable. Logically, it makes no sense: Why would you give the same dose to a man with a large penis and large plaque vs. a man with a small penis and small plaque? As packaged and tested in Phase 3, ALL patients get the same dose. Once the powdered collagenase is mixed with saline for injection, it has extremely limited storage life.

8. Collagenase can dissolve scar tissue in the penile septum. False. The penile septum cannot be injected due to severe risk of injury to the corporal bodies adjacent to this area. Collagenase will not drip down into the septum since the molecule is too big to move past the area where it is directly injected into. Almost all patients with peyronies disease have scar tissue in the septum (based on in vitro tissue sample analysis post operatively).

True or False
1. The Auxilium version of collagenase is selective for scar tissue only. It will not dissolve blood vessels. It will only dissolve scar tissue. False. As shown clearly in photos, collagenase dissolves blood vessels (e.g., capillaries in the skin). Dissolving capillaries causes blood to overflow into the skin, forming sacs filled with dark, oxygenated, blood (blood blisters in photos). This happens within hours of injection, and it can lead to permanent scarring once the blistered skin peels off. In early studies, which may not even be published, dogs that were injected with collagenase bled to death because their blood vessels were destroyed and could not be repaired by the dogs own bodily processes (essentially, their arteries and/or veins were dissolved by this chemical no animal is capable of repairing this kind of damage).

2. The collagenase molecule, once injected, will be able to move through the plaque and dissolve it. False. Collagenase (as a molecule) is huge and collagen molecules are huge. Injecting a tiny amount of collagenase into a collagen plaque in Peyronies disease will only dissolve the scar tissue in a tiny area around the injection site. The collagenase molecule simply is not able to move through a collagen plaque due to the size of the molecules. Once the enzyme (collagenase) binds to its substrate (collagen), it doesnt keep going very far.

3. Collagenase is the enzyme responsible for tissue destruction in gangrene. True. You are essentially causing gangrene of your own penis by allowing yourself to be injected with collagenase. Its a controlled gangrene but it is the same enzyme. It is isolated from bacteria, not animal sources. It is no different than botox in this regard, which is considered safe. However, botox has far fewer side effects to achieve the drug benefit.

4. Collagenase does nothing to restore elastin, which has also been destroyed by Peyronies disease plaques. True. In lucky patients, it will dissolve some collagen scar tissue. However, the elastin that existed in the tunica albuginea before the disorder started is certainly not restored by an enzyme that destroys collagen.

True or False
9. Collagenase can help men with calcified penile plaques. Unknown. Auxilium deliberately excluded men with calcified plaques from participating in the study so that their results looked better in the end.

10. Auxilium knows how well their drug works. False. Auxilium has no way to measure how well the drug dissolves the scar tissue with any standardized method. They are only looking into this NOW way after the drug has already been tested on human beings. Regarding injection, Auxilium is only guessing that the area of maximum curvature is the appropriate place to administer the injection. There is no empirical support (and there has been no empirical evidence) for any particular injection method. Maybe it should be injected where the scar is thickest or maybe it should be injected in multiple sites. All of this is guesswork because Auxilium does not even have a method to test scar tissue density in vitro (i.e., in a petry dish).

11. It was necessary to have a placebo group for this study. False. The study should have been done as a within subjects crossover study so that nobody wasted a year of their lives having to receive 15+ painful and awkward penile injections at 15+ doctor visits. This approach was (most likely) not taken because it would have extended the amount of time to get the data to the FDA, and it would have cost more money. So, about 300 men wasted a year of their lives. Although they were promised that they would get the real drug in the end, the company did not keep its promises in a number of cases. Numerous components of this study design

James Tursi Auxilium

Gregory Kaufman Auxilium