Developmental drugs & treatments - Still in trial or not approved for Peyronies

[Humorous3]

MUSICMAN - Your Mar 25 comment below said "25 per cent" improvement. Vernon's comment actually referred to a "25 degree" improvement. That puts a much different (and better) light on the results. Using the 45 degree bend you both mentioned, that results in a 20 degree bend which is over a 50% improvement. Although a 25 degree improvement will only be 100% for those with a 25 degree (or less) bend, I think that would be a welcome improvement to everyone else.

Humorous

[ComeBacKid]

G,

I ask about the injection site because it appears I have plaque surrounding my entire penis like a cast.  I can't tell what sections or parts aren't fibrotic or not cause no doctors will do an ultra sound on me.  I wonder how they would treat someone who did have fibrotic tissue spider webbed throughout the entire tunica.  Meaning, whether they would focus on injecting at one specific site or scatter light injections all over (ouch!)  

Comebackid

[newguy]

G,

I ask about the injection site because it appears I have plaque surrounding my entire penis like a cast.  I can't tell what sections or parts aren't fibrotic or not cause no doctors will do an ultra sound on me.  I wonder how they would treat someone who did have fibrotic tissue spider webbed throughout the entire tunica.  Meaning, whether they would focus on injecting at one specific site or scatter light injections all over (ouch!)  

Comebackid

Maybe they would make a judgement based on the curve of the penis? I' not sure that it'd be feasible to inject all over the penis. That said, it will likely depend on the results of these trials.

[McNally]

I was injected in the plaque at the base of my penis. While that is where the largest mass of plaque exists, it is not the only plaque. If I'm understanding this correctly, I have plaque running up a good part of the length of my penis on the top side. I also have an hour glass deformity above the injections site.

I have a sense that the procedure for injection will probably change when they proceed into the next phase of the study. Remember that this is an effectiveness study (& safety). I would think that once effectiveness can be demonstrated then appropriate treatment procedures will be fully developed.

[G.]

Just following up on what McNally said, I was also injected in just one spot, where I had the biggest plaque (about halfway up the shaft, in my case).  I also have plaque along more of the length of the shaft, but they appear to be focusing on the single biggest plaque.  My guess is that it might be helpful to inject into more than one location, but I guess that will have to wait until the next study.

G.

[Tim468]

I think that when you have a widely distributed lesion, that this injection is going to be harder to place correctly, and less likely to help.

Tim

[McBaba]

Gotta go to the government trials for anti tgf beta and get involved in trials for the help you need.  Of course that means that you will have to spend as much time writing doctors and labs as you do complaining here.

You will get nothing but sympathy here.  Sympathy ain't gon stop peyronies.  Spend your time where it can make a difference.  

[ocelot556]

http://clinicaltrials.gov/ct2/show/NCT00812838?term=erectile&rank=183

...This link mentions that they're conducting studies on Botox for the abatement of Peyronies Disease. It was my assumption (perhaps incorrectly) that Botox was supposed to make tissue firmer - i.e. removing wrinkles by tightening the skin - but isn't that the opposite of what we're trying to achieve? I don't know how cavalier I'd be in injecting a neurotoxin into my junk, either. Dead-end or viable treatment?

[Tim468]

Given that contractile "machinery" of the cell leads to a contraction of scar tissue, it makes some sense that botox might help lead to that happening less. The mechanics of action is not clear to me, though, as botox should be adherent to the acetylcholine receptor at the neuromuscular junction (or anywhere that acetylcholine acts). I didn't think that it acted at the level of fibroblasts contracting.

Tim

[Hawk]

Ocelot, Botox is of course the toxin of botulism.  It paralyzes the nerves that contracts muscles.  That is why botulism patients often have to be on a ventilator for months after the disease is gone.  So it does not tighten muscles up but relaxes them.  Like Tim, I can see SOME sense in theory but it seems like a long haul from there to controlling the Peyronies Disease process.   Plus it is not the kind of substance or the area of the body that one would want to play around with.

[ocelot556]

I don't remember seeing a discussion of superoxide dismutases before, but the wiki on Peyronie's disease links to a European study:

http://www.europeanurology.com/article/S0302-2838(05)00256-3/abstract

Now we all know how those wacky European studies can be (but was it done in ITALY? :>). Is there something to this? I'd say any powerful antioxidant would be welcome, but the study says it was an administered gel? I'm dubious that the chemicals could pass through the skin into the TA.

What do you all think?

[Tim468]

Ocelot,

Good find. The idea of the study uses liposomes which DO cross cell barriers (though I am not so sure they wouldn't get carried away by blood flow to the skin after absorption). At least there is a rationale for why it might work.

Tim

[Hawk]

After some quick searching it looked like this 2005 report was from a Japanese study.  After more searching it appears it was a multi-national study.  One problem is that there was a total of 30 patients divided into at least 2 groups.  Fifteen patients makes for pretty dubious results. http://www.urotoday.com/3351/browse_categories/peyronies_disease.  For instance, the improvement of curvature in 23% would be about 3 patients.  Improvement was 5 to 30 degrees.  One could possibly argue if 2 patients improved 5 degrees then only one had improvement, especially if the measurement was patient reported and not objective.  How much of a curve did they have to start with  A 5 degree improvement in a man with a 90 degree bend in interesting but not very helpful.

/liposomal_recombinant_human_superoxide_dismutase_shows_promise_in_treatment_for_peyronies_disease.html

These things are difficult to explain short of study bias or hellish coincidence.  It would be interesting to see more than the abstract in order to see the method of delivery, study design, and what objective measurements were used.

[mo]

In fact stem cell research has never stopped in the U.S.  This has been an emotional issue in which both sides often tune out facts and take an emotional ride.  There is much research on stem cells that have nothing to do with embryonic stem cells.  In fact advances have made it clear that non-embryonic stem cells have shown value that was thought only to apply to those from embryos.  These advances have reduced the importance of embryonic stem cell lines.

Furthermore, embryonic stem cell research continued uninterrupted.  The restriction was only on newly generated lines of embryonic stem cells.  Research on existing lines has been ongoing

Correct the stem cell research has never "technically" stopped, just the government funding stopped, which had the intended consequence of putting much embrionic stem cell research on hold for the term of the republican administration.  

Democrats began government funding again and the government is the largest money source for stem cell research.  FYI, Geron, ticker (GERN) have the most pattents for stem cell research.  Sadly none yet for peyronies, believe me, I wrote them and asked.

[Believer]

Guys,

Found this pilot study for collagenase injections to treat keloid scars. Sadly, treatment of such scars with collagenase was rendered ineffective. Apparently, scar volume reduction, if any, seems to be temporary according to this study.

http://cat.inist.fr/?aModele=afficheN&cpsidt=17872085

Any thoughts?

Also, Auxilium stock fell recently due to concerns that injections may cause a "hypersensitive" reaction...?

[Ted Williams]

Hello folks...  This is a blog of one woman's experience with Dupuytren's Disease and Xiaflex.  She had great results.  She has video links of her experience on YouTube as well.  The link is in the body of the text of this link.  

http://samanthahoffman.blogspot.com/2008/09/ever-heard-of-dupuytrens-disease.html

I have heard concerns on this page of the rumored rate of success for Xiaflex being low for Peyronie's.  Let's keep in mind that the doctors are targeting the one plaque at the center of the bend and doing very static, very uniformed injections into the site.  The rate to determine success is 25% improvement in this study I believe.  Studies are designed to get the drug passed by the FDA.  They walk a fine line at the pharmaceutical companies of keeping the bar low enough to show success and keeping the bar high enough so they can market the product effectively after they get FDA approval.  

It is my belief, that after Xiaflex is on the market, experienced Urologists that understand the disposition of Peyronie's will be able to more effectively inject the enzyme into the plaque for enhanced results.

The key to these FDA studies is uniformity and a result that can be measured.

I hope this is helpful and encouraging.  

[newguy]

Ted - Very informative. This has made me feel a little more hopeful aboout the prospects of Xiaflex.

[Believer]

Is there a way we can reconcile the study I provided several posts below with this new information? I'm a bit puzzled  

[George999]

Believer,  I think you are trying to compare apples and oranges here.  Dupuytren's and Keloids are two very different things.  This is also a reminder that we are NOT just dealing with overaccumulation of collagen here.  There has to be something underneath that is driving that phenomenon.  Simply eliminating collagen won't help, whether it is by a fastidious diet and supplement regimen OR by injections.  The body will just find a way to replace the collagen you remove.  On the other hand if the process was temporary and no longer ongoing, then removing the collagen by injection should be effective and I think that is what you are seeing with the reported case.  BUT, not every individual will respond the same way, since some may be experiencing ongoing collagen accumulation.  - George

[MUSICMAN]

I would like to receive personal messages from guys in the Xiaflex trial as to
your results. I will reply as to mine. Most guys don't want to post on forum
this information.

[bummedout]

Hello all.  I am 29 and new to this site, but have been living with Peyronie's Disease for over a year now.  I broke my penis on the rim of a toilet bowl and I'm pretty sure that's how this started.  I noticed right away, pain with my erections, indentations, and much loss of rigidity.  I went to the doctor after this and he injected something in me to give me an erection to see what I was dealing with.  I have since noticed that where he injected me I feel another lump in my penis.  And now over a year later, things seem to be getting even worse.  I went through three condoms the other night while with a girl trying maintain a very rigid erection while putting them on.  It just wasn't happening though.  At my young age, I feel very desperate.  So, I'm just trying to understand, is this new drug, Xiaflex, suppose to just get rid of curvature, or will it actually turn scar tissue into regular healthy tissue again, getting rid of my indentations.  Also, is there anything I should be doing now, to try to maintain what I have, so that it at least doesn't get worse?  And lastly, I'm trying to find a GOOD doctor, who is most experienced in treating this.  I am in the NJ/NY area.  Does anyone know of one?  Thank you for listening.  Looking forward to any and all of your responses.

[joe]

bummedout,

I'm about your age (28) and have had Peyronie's for about 2 years.  It started out as a small indentation and spread over the course of months until I had a pretty good bend, but has been stable for the past year.  I am in the Xiaflex study, but I believe I am getting the placebo since I've seen no improvement.  

Before beginning the study I had the idea that the drug melted away the Peyronie's plaque.  At the beginning of the study the doctor explained to me that the drug softens up the plaque to allow it to stretch.  He may have been dumbing down the explanation for me though.  Whatever the mechanism, it is supposed to reduce the curvature.

As far as what to do I would recommend you eat and live healthy, and taking some of the supplements in talked about in the "Oral Treatments" thread couldn't hurt.  I currently take Fish Oil, Vitamin E,  Acetyl-L-Carnitine and L-Arginine every day.  The L-Arginine specifically is cheap and helps make the erections stronger.  You'll also see that a lot of guys here recommend Pentox (need a uro to prescribe) and the VED.  I haven't tried that yet but it will be my next plan of attack.  Sorry to veer off topic - read the Child Boards for a synopsis of all the posts here.

Good Luck
Joe

[bummedout]

Thanks Joe, I'll look into the supplements you recommend.

[George999]

Just as a heads up for everyone, there has been what I consider to be a major breakthrough with stem cell therapy.  The researchers are now making progress against Multiple Sclerosis with it.  And if it works for multiple sclerosis, that should make it a prime candidate to treat Peyronie's.  This whole science is moving quickly now and this will spell renewed hope for a lot of younger guys.  I have always considered stem cell stuff to be years into the future, but this breakthrough causes me to reassess that position.  I would not be surprised at this point if stem cell therapy became common within the next five years at the rate things seem to be going.  - George

Stem Cell Study

[Tim468]

Bummed out,

Check out the "Child Boards" - starting there will give you a running start on knowing what the verious threaads here are about.

Tim

The "child boards"...

https://www.peyroniesforum.net/index.php/board,18.0.html

[newguy]

Just as a heads up for everyone, there has been what I consider to be a major breakthrough with stem cell therapy.

Very promising George! For all of the negatives, we do live in a time where so much progress is being made in so many areas relating to health, and we should be thankful for that.

[ocelot556]

The study on the stem cell MS research seems very vague, more of a journalism article than a medical one. It also states that the study group was three people? This seems to be a decade off for any applicable purpose, but still pretty interesting/hopeful!

[George999]

Its really a large scale CASE study, not a full scale research project.  Its more like the approach taken by Dr Lue with Pentox.  This is what I find attractive about it.  Its fairly simple, and seemingly it just works.  And the guys behind it are UC docs like Dr Lue.

Tim *might* be able to dig up more on it as he has more resources than most of the rest of us do.  However far away it might be for the rest of us, it demonstrates that the cure is already very likely there for multiple sclerosis and application of this treatment is likely going to happen in the not too distant future giving the persuasive abilities of the MS advocacy.  And when it becomes available for MS patients, or perhaps even before, other researchers will attempt to apply it to other auto-immune associated syndromes and who knows how many cures will be unraveled in the process.  I see it as one of these really big smoking guns that lets us know that the cures are 'out there' for all of our diseases.  Its just a matter of time before they are unveiled.

I read through this stuff on a daily basis.  That is one reason why I, even in my 60's and with multiple potentially serious health issues, find it difficult to become depressed.  You follow this stuff and you observe how fast it is moving along and you just get fascinated!  So I am determined to hang in there with the Pentox and the other stuff we know works to get me to the newer, fast approaching, more effective treatments that are on the way.  - George

[j]

I've learned how to read these breakthrough announcements.  Wherever you see "additional studies", translate it as "15 years".  If you see "promising", just read it as "needs a billion dollar investment".  

I like to reflect on the fact that we may be the last generation of humans who have to deal with some of these serious health problems.   Diseases like MS, Parkinson's, and Alzheimer's are objects of intense research and the knots are starting to unravel.  They won't be curable in our lifetimes, but future generations will not even remember them.  Solutions are probably decades away at most.

Things are changing and I think that a couple hundred years from today, our lives in 2009 will appear pretty harsh and grim, especially towards the end.  Maybe that also gives us some amount of dignity and character that future generations won't have. We have to accept our fates and go out with our chins up.  It will be the same for people in the future - but the problems, and the time scale of their lives, will be different.


 

[Iceman]

j - mate that is so so depressing

[George999]

j, I think you are entirely too negative.  Where we are now as compared to a few years ago is mind boggling.  Five years ago or so, my only treatment would be Vitamin E, period.  There would be no Pentox, ALC, Vitamin D, VED or all these other things we are finding to be helpful.  And there would be no Peyronie's Forum or resource center.  Just the same as with MS.  MS patients now have a lot of helpful therapies in comparison to just a few years ago and some of them are quite easy to access.  Vitamin D for example (High Doses of Vitamin D Cut MS Relapses).  And new USEFUL studies like this one are appearing almost daily.  Knowledge is increasing at an exponential rate these days.  The whole bio chemistry surrounding Vitamin D and cancer is being unveiled.  Now we know, for example, that cancers secrete enzymes that break down Vitamin D and thus disable its ability to destroy them.  Now the search is on for a drug that will knock out those enzymes.  We are in the final stretch in terms of solving these disease syndromes.  Peyronie's as well will benefit dramatically from these breakthroughs, albeit tangentially.  Too write off major new treatments in our lifetime is not realistic at all.  - George

[mark501]

The FDA has accepted the license application for use of Xiaflex in treatment of dupuytrens. They have given it priority review status. Action is expected by FDA by August 28, 2009.

[ComeBacKid]

J,

I agree with george, I think you are entirely to negative.  Decades for stem cell cures and cures for major diseases and disorders?  I don't think that far, lets see where we are at in one decade from now, just ten years down the road.  They are making great progress.  Pentox has been a huge gain for us, it that helps and works, just stay on it for a long time, until they come up with a cure.  I see it more as a drug to keep you from progressing and small improvments until a cure comes a long.  I plan to stay on it for as long as possible.  I stocked up ahead of time with 6 prescriptions, and store it in a huge pill jar.  If my doctor eventually tires to pull my prescription I'll have at least a year of it, I'd get more than this, but its only good for a year from the date you get it.  I keep telling people to get on this cause it is helping me again for the second time.  My erections are full and solid, and my penis is hung and full when flaccid, it feels healthier and is softer, but still gets hard when semi erect, and feels damaged.  I don't think it will cure you, but it will keep you functioning, and keep you at bay with small improvements.  Xiaflex study is moving a long, and could be on the market within a year.

Are you on pentox?  Did you try it?  

Now that they overturned the stem cell funding, your going to see more money pour in for treatment research and more results.  You have to stay patient though, I've been waiting for a cure for a decade now, it could be another 5 years to a decade for me...

Comebackid

[j]

I first heard about injectable collagenase in '97 when I read a  paper about successful trials at SUNY in 96.  As Mark501 posted, Xiaflex is now, possibly, set for FDA approval by the end of 2009.  That's 13 years.  All the other possible treatments you guys are mentioning - Pentox, ALC, vitamin D - were already approved by the FDA long ago.

"15 years", by the way, is what my hand surgeon told me when I had Dupuytren's surgery in '97 and  I showed him that paper about the SUNY trial. He said even if it works, that's how long it would take to get to market.

That was my point - development and approval of a new drug therapy, in this country, now takes many years and huge sums of money. And of course this process only begins after all the research that developed the treatment.  Even if a new drug is created  in a lab this week that can roll back Alzheimer's, it would probably be too late for most of the people who have it today.  If an existing drug were found to work, that's another story.

My post wasn't intended to be as gloomy as the responses are indicating.  I don't think Parkinson's, for example, will be cured in my lifetime.  Peyronie's, though, may very well be quite treatable in a few years.  Maybe just a couple of years.

Realism isn't pessimism.  

[MUSICMAN]

I think "J" is right about the time frame. Xiaflex might get FDA approval by the end of this year for Dupuytrens. You might look long and hard to find a doctor to use it off label for peyronie's, and it won't be cheap. Xiaflex will not start phase III trials for peyronie's until the middle of 2010 and who knows how long for FDA approval. My condition with this disease is not of inconvenience but of not being able to have sex at all. I am not 23 years old and at my age I don't think I will see these things come to pass. Some of this attitude of mine is the mental anguish of dealing with this disease.

[bones54]

i'm sitting in my urologists office right now.   just got my 3rd injection of marcaine, xylocaine and now again marcaine.  stupid sh@t wont block me very well and when he tried the xiaflex ..worst pain ever.
i have enough local anesthestic to set off the sensor at the airport when i fly home tonight.
i try and kid about this but , damn...this disease is tough.
cant have the surgery until the study is completed...which for me will be octobre ( say it like you were spanish).
im going to start posting more here...need some place to rant...
oh...my curve got worse by 5 degrees...and my doc thought i got the drug by the response i had locally.
another oh...im a hand surgeon...not sure if i want to see another vial of xiaflex agin ( say like you were a cowboy)

[ComeBacKid]

J,

I agree with you about realism, but lets face it they just opened up a flood of federal dollars for stem cell research(which by the way never stopped in the usa and was always going on anyway), many more dollars are going to go to scientists who said they had their hands tied with no funding.  Although on the other hand what you say about collaganese is true, it took awhile, but there was no private sector company willing to take it up.  Thats why its important to get the info out there about this disease.  Theres thousands of men all across the world that have this problem but have no internet connection and no health care to see a doctor.  It is more common than you think.

Since collaganese has been seriously taken up by a serious company, it has moved along fairly quickly, what 2-3 years now?  Thats not that bad or inefficient, the FDA has to do these studies, and we shouldn't denegrate them even if slows the process down.  After all would you want to go in for a xiaflex shot that wasn't tested and have it destroy the inside of your penis?  August of 2009, wow thats sooner than I even though, this is something to cheer in my opinion, I'd be camped out to sign up at the local doctors office.  I'd put my phone on auto dial and just keep ringing until someone picked up!!!! And in the meantime I'd keep stockpiling pentox and keep taking three pills a day!!!!!!

Comebackid

[newguy]

Comebackkid - It certainly is encouraging that Xiaflex "may" be available at some point in the near future. Depending on your definition of near. Is there anything that can conclusively draw from the Xiaflex peyronies trial so far though? Has it truly been a success? Most of those taking part appear to have improved by 25% of more, which of course is certainly better than nothing. Are the actual results available though, so that we can pick through them? I suppose that's unlikely at this time.

[RichB]

That post about xiaflex is the news I needed to make the rest of my week actually enjoyable  

[newguy]

That post about xiaflex is the news I needed to make the rest of my week actually enjoyable  

Yes, it is definitely promising to see new treatments potentially being made available to us in the near future. Especially for those recently diagnosed, there will at least now be more options on the table for them. That's half the battle I think really. It helps focus the mind to recognise that there are different approaches and strategies out there, even if none of them are perfect. It makes it seem even more antiquated that some people are still told "here's some vitamin E, now on your way...".

[RichB]

It's the idea that progress is being made that makes me keep up hope. I am confident something will come up that is pretty effective by the time I reach my 30's, which is a long time, but it's better than nothing. I feel like the Vit E thing is based on the fact that most urologists are pretty uneducated about this condition.

[jackp]

newguy

Do not be to quick to dismiss vitamin e. It is an old treatment that worked well for many of us "Old Timers" to Peyronies. The first 12 - 18 months are crucial and vitamin e is easily acquired.

Jackp

[newguy]

newguy

Do not be to quick to dismiss vitamin e. It is an old treatment that worked well for many of us "Old Timers" to Peyronies. The first 12 - 18 months are crucial and vitamin e is easily acquired.

Jackp

Sorry if my comment came out wrong. I didn't mean that it's an ineffective treatment (in fact I myself take it), but rather that those urologists not keeping up with developments sometimes avoid mentioning any other potentially helpful treatments unless prompted to research, or worse still point blank deny that some treatments are of use when we know that they can be (VED etc).

[bluth]

August of 2009, wow thats sooner than I even though, this is something to cheer in my opinion, I'd be camped out to sign up at the local doctors office.  I'd put my phone on auto dial and just keep ringing until someone picked up!!!! And in the meantime I'd keep stockpiling pentox and keep taking three pills a day!!!!!!

For Dupuytren's not Peyronie's. Though maybe you were actually implying that.

[Hawk]

I agree that J may not always be a bowl full of sunshine but he has been around a long time.  He is savvy and rational. His time tables are realistic.  Keep in mind that something widely available in 15 years IS the next generation for many of us.

Also remember (I forget that many of you were not even born) that in the 50's, mainstream medical science projected a cure for cancer within 10 years.  In 2009 (50+ years later) the cure for metastatic cancer (cancer that has spread) is barely higher than it was in the 50's.  Most of the improvement are in prolonging life or stopping some early stage cancer with early diagnosis.

We will soon see the fruits of things planted (researched) 15 years ago.  Fifteen years from now we will see the fruits of current new research.  

Money thrown at the problem today will result in exciting new articles within 2 years that will be treatments in 15 years.  That is just how it works.  Plus, money to throw at anything is pretty scarce.

PS: George you mention the VED.  We gave that to the medical community that resisted it for years. In fact they scoffed at the idea and many still do.  We gave that to them, they did not give it to us so that is not a valid example of medical breakthroughs.

[sandy1]

Good News - Auxilium Pharmaceuticals will be up for approval by the FDA on Aug. 29,2009. If they get approval they plan on going forward with the product within 60 days after. The product was developed to cure a hand problem but is also thought to be effective with Peyronies and other concerns.Check Auxilium's Press Releases for full story.
I can't wait to try the product!

[George999]

PS: George you mention the VED.  We gave that to the medical community that resisted it for years. In fact they scoffed at the idea and many still do.  We gave that to them, they did not give it to us so that is not a valid example of medical breakthroughs.

And who knows what all else we might be able to give to them in the future.  Some of the things being looked at these days are very accessible to the point that if they don't pursue, we might well be able to.  I am really NOT intending to credit the medical community for all of the good things we have today.  Much of that progress is due to availability of the Internet and other modern miracles.  - George

[RichB]

I feel like the VED will be a crucial part in treatment when successful injections are created. It's not like D. contractures where the physician can stretch the hand out. It's the only thing that can successfully stretch the tissue in a practical manner, also stretching things uniformly, which is also a benefit.

[ComeBacKid]

RichB,

Your right, it gives a solid uniform stretch, this is why I'm a big fan.  The fastsize stretcher doesn't give the uniform stretch like the VED, and you can pump the blood into ever little knook and cranny!  It will most likely be a part of any future treatment, however it doesn't give a great length stretch, fastsize does this well, perhaps both will be used, who knows?

Comebackid

[LWillisjr]

Good News - Auxilium Pharmaceuticals will be up for approval by the FDA on Aug. 29,2009. If they get approval they plan on going forward with the product within 60 days after. The product was developed to cure a hand problem but is also thought to be effective with Peyronies and other concerns.Check Auxilium's Press Releases for full story.
I can't wait to try the product!

Even though it becomes FDA approved doesn't mean that doctors will start to use it. The experts will probably continue to use their present practice of Verapamil until some study shows that Xiaflex is better. I'm anxiously waiting the results of the Xiaflex trial.