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

[bodoo2u]

I found this site after reading an article in the alternative magazine Nexus. I jotted down the Website and accessed it when I got home.

The info on stem cells is similar to the contents of the Nexus article, which leads me to believe that the company that produced the product paid for the article. Nevertheless, can any of the knowledable members of the forum tell me if it's possible to produce stem cells by ingesting or topically applying colloidal silver? Wouldn't that be wonderful.

Of course I'm talking about a quality brand, which this manufacturer says its product is  

\http://www.live-silver.com/StemCells3.htm

[jackisback]

They're in the second part of the second stage of testing for Peyronie's, I think I read that they expect to inject their first penis with the substance early next year. I hear the manipulation after the Dupuytren's shots don't feel to good, so I'd expect the Peyronie's ones wouldn't be too pleasant either. But there's something about this condition that I doubt very many of us are worried about the pain.

[ohjb1]

I understand that dosing with Xiaflex will begin late this month or early next month.  Does anyone have additional information?

Second question - For anyone with some knowledge of anatomy.  It seems that Xiaflex injections are safe for Dupuytren's contracture.  Can we then assume it will be safe for penile injections?

[jackisback]

I don't know, but I see that all these money magazines are now recommending it, and the prices has gone up a lot this summer. Damn it, I've been thinking I need to set up an account to invest in it, but have just been too lazy.  Really need to get on that and do that. You make money in the stock market when you have information that others are not aware of, and we all have definitely been aware of this stuff long before most market people probably were. Now the google news hits for Auxillium is relatively huge to what it has been.

[jackp]

ohbj1
Penile Injections. Don't Do It. I have corporal fibrosis from trying Trimix and it made things worse.
I know I have tried all things legal and some that are not. Just be careful what you inject into your penis.
IMHO.
Jackp

[LWillisjr]

For injections in the hand, I doubt that they do any numbing first. Which could explain why there might be some pain afterwards. I know for Verapamil injections from personal experience that they do numb the penis first before the injections. So I would think the same would be true for Xiaflex.

As JackP points out, there are some risks. But there is also some documented evidence that the Verapamil injections do help in some cases. I suspect the same will be true for the Xiaflex. Has has been stated many times on this forum: What will work for some won't for others and vice versa.

[j]

I have Dupuytren's (along with Peyronies Disease) and I've been following the Xiaflex story for over 10 years now.  I haven't had the injections, but I've read first-hand reports and I think I understand the issues.

With Dupuytren's you have hard, tough cords restricting the motion of your fingers. The cords are usually pretty distinct from the surrounding tissue, and just severing the cord is often enough to restore fairly normal motion. Xiaflex is injected into one spot in the cord and allowed to dissolve the collagen for a while; then the finger is forcibly straightened with considerable force to complete the job by snapping the weakened cord.  There is literally a 'pop' when that happens.  To prevent the enzyme (collagenase) from damaging surrounding tissue, they don't inject more than is necessary to simply weaken the cord enough for it to be snapped.

The procedure has worked well in trials. But obviously Peyronies Disease is quite different; the collagen is more integrated into the surrounding tissue, and that tissue is very easy to damage, and very hard to repair.

So I don't know how they'll use Xiaflex for Peyronie's.  Maybe they'll inject small amounts in several spots and hope to weaken the collagen enough to restore some stretchability.  I don't think it will be a 'cure', because it won't be possible to dissolve all the unwanted collagen.  But with a careful strategy of multiple and/or repeated injections, I think it could really improve things for a lot of us.  The key will be urologists who care enough to experiment, do the imaging and the followups, and try to refine their technique.  

I think it will work.

[bodoo2u]

Thanks J,

That was a very good observation and yet another reason why I have not returned the letter I received from a medical group that is planning to test Xiaflex on Peyronies. I'm bad, but not as bad as a lot of the guys on the forum, so I don't want to end up damaging myself further and needing surgery.

Bodoo

[bentweenie]

Peyronies is a form of fibrosis, and there's lots of research already going on regarding fibrosis, for other reasons.  Fibrosis is a big problem with radiation treatment for cancer, for example.  New antifibrotic drugs may very well turn out to be effective against Peyronie's as well as other, higher-profile conditions.

Also, let's not forget: the one and only drug which has definitely shown success against Peyronie's - injectable collagenase - is in Phase III trials and apparently still grinding its way toward the market.  These things take so ungodly long  - the road is so twisted - that eventually the "process" just becomes part of the landscape and we stop thinking or talking about it, because it's frustrating.  But in this case, I think it will go to completion, and guys who actually have Peyronie's (and not some conjunction of other problems and anxieties) wil be able to get real improvement.  

If you want to be an advocate, then buy shares of Auxilium, show up at a stockholder meeting, get in front of the microphone and demand to know what's happening with this product.  

I spoke with Dr. Gelbard (Burbank, CA) re Clostridium collagenase, and he said it's now in Phase III trials for use in Dupuytren's contracture patients only (not Peyronie's). He said that it's looking very good, with little or no adverse reactions. He is now conducting Phase I trails of collagenase treatment of Peyronie's patients, and he needs more participants.

[George999]

I do think that translating Xiaflex's success with Dupuytren's into success in treating Peyronies is going to be difficult.  That is why I suspect that in the long term Alagebrium Chloride will likely turn out to be the more successful solution.  Instead of targeting Collagen like Xiaflex, Alagebrium targets the crosslinking itself which defines scar tissue.  - George

[ohjb1]

I believe Xiaflex is beyond Phase I testing and the current trials will be considered Phase IIb.  Does anyone know how many men have been previously tested with Xiaflex for Peyronies? I believe, but am not sure, the original company may have done some testing.

I went to the Auxilium web site and they indicated that Xiaflex resulted in an average 25% reduction in curvature. Since I have a severe case, a 25% reduction won't do it for me. Has anyone seen the complete results from earlier testing to see if those with  more severe cases have had more success in terms of percentage reduction?

Thanks.  

[j]

I think the goals of early stage testing are to show that a product does no harm, and has some positive effect.  So, dosage and treatment plans will be very conservative.  The last thing they want to do is inject too much, cause collateral damage and blow the whole deal.   25% improvement is enough to convince investors that this product will sell.   I have no inside knowledge, but based on how this drug works it seems to me that more aggressive treatment is certainly possible and will be tried in time.

[Kimo]

Ohjb1,,,,I haven't had any experience with this Xiaflex,,,,but i did have great success with vita-E and Topical Verapamil and i had a severe case of peyronies,, check out this website as it kinda comes close to what i looked like,  www.revistaciencias.com/publicaciones/EEElkyEkFkxaTlhnDF.php

I was on the Topical and E and seen results after 3 months and much better results after 5 months..was very expensive but i felt it was worth it to get my penis back straight....MY penis looked much worse than this picture,,twisted and bent like a donut all the way back into my groin..

This is just my opinion and results for me,,,,,,,,kimo

[wayne999]

is topical verapamil something you have to get a doc's prescription for?

have subsequent tests after the one on the following site have had mixed results about topical verapmil??
http://www.phoenix5.org/sexaids/basics/penile/VerapamilPR042600.html

The site itself claims the patent holder/inventor was ridiculed by those who had seen sporadic results from verapamil injections....so I assume, scientifically, this is still in a grey area?

[George999]

Wayne,  Topical Verapamil or "TV" as it is known in many circles does indeed require a prescription.  It was the subject of intense conversation on this very site some months back when it was just emerging.  It was widely panned by guys who tried it and then claimed it to be ineffective and also implied that its distributor was lacking in ethics and not telling the whole truth about it.  But now you have people like Kimo claiming that they were helped by it.  At this point, I think, perhaps, it is like a lot of Peyronies treatments.  They seem to work for some people and not for others.  There is still a lot about Peyronies that is really not well understood and I believe that various efforts to control it may conflict to prevent improvement or conversely be synergistic to facilitate improvement.  Those few who are benefiting or have benefited from TV may actually have chanced upon such a pathway to improvement.  So if I were to look to TV for help, I would seriously study the efforts of those who have gained benefit from it.  - George

[Kimo]

George,,,,you are correct in saying the TV doesn't help everyone...When my URO prescribed it for me, he said it might not work,,,BUt he did also say it only works for a few men and it was worth the try..I do admit that i was very fortunate that it worked for me...

I forgot to mention that in my post..I felt that it was worth the try  and was willing to take a chance,,and i am so glad i did...i was very punctual about putting it on every morning and every evening, was willing to do anything at that point to get my penis straightened out...My URO also said that he felt vita-E would help the TV to do a good job,,,IT Worked..

This is just my opinion and experience,,,,,,kimo

[George999]

Nick,  I'm not sure that this is the best venue to look for a donor.    - George

[jackisback]

That's what I'm thinking. If John Wayne Bobbit can have it cut off and then star in porn a few years later, shouldn't our conditions be simple? Oh well, that rant isn't productive.

[George999]

Mr. Bobbit suffered major trauma and yet did not end up with Peyronies from his ordeal.  With that degree of trauma one would expect total loss of function due to a massive case of Peyronies.  But what this is actually demonstrating is that trauma is JUST A TRIGGER.  It is NOT the cause of Peyronies.  Thats why we have to address the ROOT CAUSES.  Those are the forces that establish and fuel Peyronies disease.  And those are the forces that it is important to identify and remediate.  - George

[alcohen]

From what I have researched, you hit the nail right on the head George.  It seems like certain people for whatever reason are more susceptible to develop Peyronie's as a result of major or minor trauma to the penis.  Not every single person who injures their penis in some way develops Peyronie's.  Because of how much variability is involved with not only the onset of this disease but the progression as well, I doubt there will come about a method that will cure or even definitely help each and every person's Peyronie's.  From reading everybody's stories on here, it seems every person is different in regards to how treatment has affected them.  I am new to this whole ordeal and from those who have read my posts you can tell that I find it very hard to stay positive.  I am being proactive though and am trying everything that I possibly can to help myself to have a better lifestyle.  I may never be completely back to my old self but I just refuse to believe that I will never be able to have sex with my girlfriend.  We both love each other very much and our relationship was progressing to this point when my symptoms happened.  It has hit me very hard.  She has been nothing but helpful in every way and went with me to my appointment with Dr. Carson at UNC Hospital though he did not suggest that we bring her in when I mentioned that she had come with me.  He wanted to wait until next time when they do the doppler scan as he could not feel any scar or plaque during my visit.  When I have erections though, it is most certainly there...

These are just some thoughts.  Perhaps the Xiaflex testing will continue and one day that by itself or perhaps that in conjunction with another form of as yet undiscovered tretment will end up curing this...

[ohjb1]

I know for a fact that testing with Xiaflex is about to begin. Has anyone receive any written notification from their physician's with the details?

Shouldn't this information appear on the clinicaltrials.gov website?

[George999]

alcohen,  Actually, the more I have learned about Peyronies, the more optimistic I have become, both about myself AND about others.  For one thing, I have learned that the process underlying Peyronies is referred to as "Glycation".  And as I have learned more about that process, I have become very impressed as to the number of things I can do to limit that process AND the amazing progress of research aimed at stopping and even reversing that process.  I really do think that the future, even the near future, holds great things for all of us.  We are all so blessed to live in the age that we do.  Only a few short years ago there would have been no Pentox, no VED, and no forum like this one where we can all learn and share our experiences.  Also remember that what appears to be Collagen can actually be simply inflamed and swollen tissue that can immediately return to normal if the inflammation is quelled.  ONLY an ultrasound can tell the difference between inflamed tissue and actual scarring.  And I believe (someone correct me if I am wrong) that a Doppler Ultrasound is used to analyze blood flow.  In any case I wish you the best in this.  But I do think the future looks bright for all of us.  We just need to do what we can to take charge of our health and make it better and know that as we do more and more tools will be coming available to us as research and development move forward.  - George

[alcohen]

ohjb1, I found this information at:
http://www.curepeyronies.net/index04Xiaflex.html

I am not sure how recent this information is, or even how accurate this website is.  But it seems interesting and food for thought...

"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."

[George999]

The information posted below by alcohen just makes sense.  Auxillium has a purpose of getting Xiaflex on track for approval for use on Peyronies.  They will not achieve this by enrolling the most difficult cases in their trial.  But that DOES NOT MEAN that Xiaflex will turn out to be ineffective against either calcification OR ED.  It, in fact, may or may not prove helpful.  It DOES mean that it would certainly be more difficult to achieve effectiveness in such cases and so that is definitely not where they are going to start.  But IF approval is granted for Peyronies in general, it WILL be used in such cases as well by doctors who are willing to test the limits.  Auxillium is just not willing to risk the extra time and money testing such cases might cost them at this point.  So, while I think this is good information, one has to be very careful what one reads into it.  To any out there with calcification OR corporal or smooth muscle fibrosis OR even a leakage type scenario, I would say not to give up hope.  The natural course of the body is to heal and there is ALWAYS hope for that to happen.   - George

[Old Man]

sgtnick:

I may be wrong and stand to be corrected, but believe it pronounced as follows: zee-oh-flex.

Most words starting with the letter X  it takes on the sound of Z, so that is my thinking on it. Others may know better from other sources, etc.

Old Man  

[George999]

Interesting news out this morning:  Biospecifics is quietly upping the ante on Xiaflex for treatment of Peyronies by buying rights to its use ahead of time rather than paying royalties later on.  This essentially means that Biospecifics, having reviewed the results of testing so far, have decided that they want to increase their risk on its success significantly by putting money down ahead of time.  This reflects increased optimism on the part of Biospecifics as to the eventual success of Xiaflex in the treatment of Peyronies.  - George

Biospace: BioSpecifics Technologies Corporation (BSTC) Buys Down Royalties for Peyronie's Disease 9/5/2008

[ohjb1]

George, i do hope that you are right.  However, i suspect that the optimism is due the results on Dupuytren's Contracture.  I do not know of any results for relatively large trials for Peyronies.

[Iceman]

GEORGE999,

In your opinion when do you think there will be a cure or something we can take for this??  

[George999]

Nemo,  To be really honest about this, the term "a cure" makes me really uncomfortable.  I see a lot of very effective treatments, but no real silver bullet, at this point.  I think guys who really work every angle, even now, can pretty much achieve a cure.  I have held this thing at bay for a long period with ALC (along with really working on the healthy lifestyle aspect).  And now, with the addition of Pentoxifylline, it is REALLY getting pushed back.  I really believe that the roots are Peyronies for most guys are in a basically unhealthy lifestyle.  And I think that in most cases they are completely unaware of what constitutes an unhealthy lifestyle.  And without serious lifestyle changes, no amount of treatment is going to solve the problem.  BUT, I am convinced that it will be easier to CONTROL Peyronies as new products such as Xiaflex and Alagebrium come on line.  And for those who are resistant to lifestyle changes or have health conditions (such as prostate issues or genetic issues) that complicate the whole thing, the VED is the best option.  In fact, I consider the VED to be the closest thing to a silver bullet available today.  But of course, it is not a silver bullet in the sense of a cure, but it comes very close in the sense of a treatment.  I think there are quite a few guys who are nearly totally asymptomatic as a result of regular and disciplined VED usage.  - George

[ohjb1]

George999 -  you seem to be extremely knowledgeable. I have an 80 degree upward that essentially renders me nonfunctional. I have tried verapamil with poor results.  Dr. Levine has recently suggested a traction device, which in his opinion would help my condition. Do you prefer the VED vs the traction? If you prefer the traction would you suggest a particular brand or direct me to their website.

At this point, I do not want to take any additional medication because I am only a few months post a cardiac bypass operation.  

[LWillisjr]

ohjb1,
Dr. Levine is affiliated with a company called Fastsize. You can google and get their web address. LEvine will also provide you with a discount code for $30 off. I'm using one now post surgery to stretch the graft and to regain some length lost during surgery.

[wayne999]

ohjb1,
Dr. Levine is affiliated with a company called Fastsize. You can google and get their web address. LEvine will also provide you with a discount code for $30 off. I'm using one now post surgery to stretch the graft and to regain some length lost during surgery.

lwillis, do you mind sharing how much length you lost? The grafting procedure is supposed to result in lower length loss relative to the nesbitt from what i understand, so it would be good to hear your experience with this.

[George999]

ohjb1,  I definitely would choose VED over traction simply because the VED is, in my thinking anyway, a much more proven approach than traction.  If you page back through the VED thread in this forum, you will find multiple success stories resulting from VED use.  Traction is a new approach that I simply don't have as much confidence in.  And that is not only due to the fact it is new and unproven, to be honest, I don't have as much confidence in the concept.  All of this of course does not mean that traction doesn't work, but I suspect that it never will be as good of a solution as the venerable VED is.  But you have to remember, this is not only about treatment options, this is also about business and about doctors who may have money invested in a particular product or concept.  This is a sort of seamy underside of medicine.  So, beware.  (Just my opinion)  - George

[ohjb1]

Thanks George, I appreciate your feedback

[LWillisjr]

Wayne999,
No problem. Reminds that I need to update my personal information as well. Dr. Levine had me originally wear the Fastsize device during my initial treatment of the VI injections. Neither worked for me but I did pick up 1 centimeter prior to the surgery.  I was right in the middle of what I understand is a normal distribution of just under 6" when erect prior to the addition of the 1 centimeter. As a result of the surgery, I have lost about 3 centimeters.

I am again wearing the Fastsize device per Dr. Levine's recommendations and he believes the length will come back as the graft continues to heal and stretch. I will tell you, and I never though I would say this, but I gladly give up the 3 centimeters to become straight. The wife says she does not notice a difference. If she is saying this to make me feel good.......... it is working  

[Iceman]

GEORGE999 - when will Xiaflex and the other new treatments  ( algaebrium??)) come on board for public useage???

[Iceman]

How come these  2 products Xiaflex and Alagebrium  will take so long 2 years or more - is there nothing sooner??

[George999]

Xiaflex is in trials now for Peyronies, so it should be available in a few years if all goes well.  Alagebrium is in trials now for ISH, once it gets approved for that, research physicians may begin trying it off label for Peyronies.  So alagebrium is a few years out.  - George

[Hawk]

Iceman,

The short answer is that they have to have adequate studies to find out if it works or makes things worse.  I miracle cure forum today would take at least a few years to get to market if it was a new drug.

This condition was documented 250 years ago and we still have no consistent treatment.  Sadly many diseases have no good treatments and many of those treatments kill people.  By those standards, 2 years is right around the corner.

[George999]

Just to briefly note that Synvista, the maker of alagebrium has just announced success with a somewhat breakthrough product for heart disease.  This should bring them additional revenue to help fund alagebrium research.  It also demonstrates Synvista's expertise in this area.  - George

Data Confirm Synvista Therapeutics Haptoglobin Diagnostic Test Kit Success In Rapidly Determining Cardiovascular Risk In Patients With Diabetes

[ohjb1]

Has anyone on this board been contacted about the Xiaflex trials?  I have  

[mark501]

Auxilium has announced that Xiaflex Phase IIb (dosage) trials have begun. There are 120 patients at 11 sites. Criteria: Ability to maintain an erection and curvature of between 30 degrees and 90 degrees. Good luck to all the participants.

[Ticker]

How does one volunteer or participate in the study for the phase IIb trials??

[catfish]

Interesting that this site has been operating for several years and today we have the first piece of significant info and there is not more interest

[Mick]

Your post is #493 on this thread, and most of the others deal with Xiaflex!

[Iceman]

how does one get involved in the trials if out of the USA

[ohjb1]

Based on my limited knowledge if you are outside the US you may want to check Google and insert clinical trials.gov and then type in basic search, type in peyronies and see what the criteria is concerning anything going on outside the US. right now information is not posted on this site. just keep checking. It is discouraging that the trials will have so few people.

I spoke to the nurse in another doctor's office (not Levine) and she said they will initially be dosing 10 men, but having a waiting list of over 100.

[Iceman]

has anyone heard of  pirfenidone?? - is this approved and does it work??

[George999]

Iceman,  Pirfenidone is really pretty much a "better" Pentox.  It does the same thing Pentox does, only more effectively.  It is targeted at the same types of diseases Pentox is.  The difference between the two is that Pentox is an old tried and true generic drug and Pirfenidone is a brand new product still undergoing trials whose long term safety risks have not yet been assessed.  It has not been approved for general use and is, I believe, currently in Phase III FDA trials.  It IS being provided for people who are literally DYING.  It is not available for people with Peyronie's and probably won't be for a long time largely due to potential safety issues and lack of specific FDA approval for Peyronie's.  Eight to ten years from now it *may* be used to treat Peyronie's if all goes well.  Oh ... and if it were available now, I guarantee, it would cost you far more than you could afford in a life time.  So, while it is certainly of interest and has actually been discussed here before, it is not really of any current usefulness in terms of Peyronies.  For people who are dying of fibrotic diseases, though, it may well save some lives.  It is that good.  - George

[Iceman]

GEORGE999 - if its that good maybe there are places in India/China that rip off the ingredients that we could buy it??