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

[Hawk]

I really want to put a drug from unethical rip-off artists from China in my body as a way of improving my health.  These are the people that don't blink at contaminating our pet food or our children's toys.

[Tim468]

How about putting Melamine in milk to increase it's apparent protein content despite the fatalities associated with doing that?

At least corporate criminals get the death penalty in China - they got that going for them.

Tim

[George999]

To Hawk and Tim's comments I would add this.  Pirfenidone is an experimental drug whose long term effects are unknown at this point.  Its short term effects are very impressive.  But what about ten years from now?  WE DON'T KNOW THE ANSWER TO THAT QUESTION YET.  Do you really want to take that sort of risk to fix your broken penis?  AND, we know its a great fibrosis drug, but we don't even know at this point how effective it would be on Peyronie's.  While it quite possibly be more effective than Pentox, it very likely won't be a magical cure.  I'm sorry, but I most certainly don't want to make that kind of gamble for my penis and I am VERY willing to take REASONABLE risks.  And TO THIS add the risk of buying it from an disreputable source, I think you would be asking for major trouble and possibly death.  This is a drug that I would take IF I WERE DYING.  Since I am not dying, I think I will wait a few years and let some other people go first, then make sure I am buying the real thing.  And I would strongly suggest that you do the same.  - George

[jackisback]

On Xiaflex: do you guys think it will be covered by the better insurance plans? I've heard that ED drugs are (at least partially) covered (not sure if that's true), but that usually birth control pills are not (raising issues of unfair gender treatment).

Anyways, I think the surgery is covered, so why not the less invasive Xiaflex?

I ponder this because I just graduated, and don't like my job, but it has great insurance benefits. If Xiaflex takes 2 years or less to be approved for Peyronie's, I'm thinking I'd be a fool not to wait it out.

[George999]

Jack,  My thinking on this is that unless you are really in deep trouble with Peyronie's, it will most likely pay off in the long run to simply use current non-destructive treatments (Pentox, VED, etc) to keep things under control as much as possible because, definitely, there are going to be more options in the next few years.  And the younger you are, the more likely you are to see very effective treatments before your youth is over.  - George

[jackisback]

Yeah George, I completely agree. Of course I should try to do what I can now. It's not like we can bank on the idea that Xiaflex will even be approved or highly effective, although it is promising. Just got some pentox from a mexican pharmacy. here's to that.

[jon]

FYI, I just got a call from Sue @ Auxillium. Human trials using xiaflex for Peyronie's are recruiting now.
http://clinicaltrials.gov/ct2/show/NCT00755222?term=peyronie%27s&rank=1

There's none near me, but dammit if you're close go sign up.  

[swbasil]

I too, just received a call from Auxillium advising that the recruitment for volunteers is
starting now. Apparently the study will run for 36 weeks with a 6 week interval between
injections. If you can afford to make 6 trips to one of the locations, I believe this is the
best course of action available. I'm attaching the website --

http://www.clinicaltrials.gov/ct2/show/NCT00755222?term=peyronie%27s&rank=1

Good luck -

swbasil

[jon]

well damn, I might just have to fly out to LA 6 times if I can get on there.  

[j]

And this is only Phase II.  Glaciers move quickly by comparison.

[Old Man]

j:

In other words, none of us should hold our breath waiting for results, huh?

Old Man

[j]

In 1996, a small trial was performed at SUNY showing that injectable collagenase could release Dupuytren's contracture.  Inject it, let it work for a few minutes - snap the cord. Peyronie's "plaque" is the same tissue, right near the surface, easy to locate, inject and image.  There is little doubt it would work and there are no real safety issues.  It's just an enzyme that dissolves this particular sort of collagen.

I'm now 57, 12 years older than I was when I first read that report, and in addition to Peyronie's, I've lost a fair amount of functionality in my hands to Dupuytren's.  Many millions of dollars have been raised and spent - and some people have already made tons of money -  but injectable collagenase, now called Xiaflex, is still not available.  Trials for Peyronie's have years to go even if nothing goes wrong. By the time I actually receive an injection of Xiaflex, the whole middle part of my life will be gone.

[Iceman]

J- man thats depressing - hey at least your alive lets all be thankful about that!!!
Ive had Peyronies Disease now for nearly a year and I am learning to live with it - Im doing everything thats on here - even went to see lue...lets just all stick together on this and help each other out and if we do come across anything that helps improve matters then lets post it here...

[Iceman]

One other thing - can we start a thread here for people who have had the clinical trials and note their feedback,,,

[j]

My life is ok. I'm still functional.  What make me angry, looking back, is the absolute inability of the medical industry to simply give us this product. Years go by, then more years... there's no real "research" going on with Xiaflex, today, it was all completed by '96.   It's just bureaucracy, and greed, followed by more bureaucracy, and greed.  

[Iceman]

J - well at least they have started trials - isnt that progression? I mean this is a positive step in an area that we have absolutely no control over.

[alcohen]

I can easily make the trek to the Virginia location and am doing everything in my power to be a part of the trial.  I meet all the criteria other than the official diagnosis which I will not recieve until December 29th when I have the blood doppler ultrasound done.  I will keep you guys up to date WHEN my trials begin.  I WILL be taking part in these trials.  

[ohjb1]

 to alcohen - i am a little puzzled, if you had an exam why wasn't the ultrasound done at the time of the initial exam?

[alcohen]

I was very puzzled by that as well!  Many of you report that your uro has done an ultrasound at the same time as the first consult.  The doctor, Culley Carson, is very knowledgable about Peyronie's disease accoding to numerous sources.  He knew that was what I was going to see him about.  After he did a quick hand-test on my penis I was very startled to see him start talking about getting me back in there for a doppler ultrasound...  It takes me a little under 3 hours to get to his location so I was a little depressed at having to wait.  I got more upset when I went to checkout and the receptionist told me that they only do this 4 times a year (this is at UNC Hospital Urologic Surgery department) and that I wouldn't be able to be seen until possibly November...  This was on August 18th.  It is not done by Dr. Carson, but instead someone in the "Vascular Studies" section of the hospital according to the form they sent me.  I recieved two upcoming appointment cards in the mail yesterday.  They are both for December 29th, with the first being at 9 AM to do the ultrasound and then a 10 AM appointment in the "Urologic Surgery" section of the hospital with Dr. Culley Carson.  It is very frustrating to have to wait this long to have something done that should have been done long ago on me.  

My first urologist told me when I asked that there was no scan that could be done to see if there was anything inside my penis...  The second one told me that there was a scan that could be done but that there was no reason to have it done because nothing would be found by doing it and that it would be a waste of everybody's time.  He is also the one that guaranteed I would be better in 3 weeks two months ago.  

It is extremely frustrating because the Xiaflex website says that you need to have been diagnosed for at least 6 months to take part in the trials...

[ohjb1]

Sorry al, something doesn't sound right. As someone who has very good health insurance, i have seen 2 physicians who are considered Peyronies experts. both conducted the ultrasound at the first visit.  Secondly, it seems as if you could move things up if you called another doctor who will perform the ultra sound at the initial visit. I don't mean to sound negative, but i don't think you chances of participating this current trial are very good.  

[alcohen]

http://www.menshealthpd.com/cm-pdz/index.html

Here is one of the website's detailing this urologist.  He did a live chat recently and answers several questions here via video.  I don't understand why it was not done upon my first visit.  I think in the back of my mind that he did not expect to have to do an ultrasound after seeing my age and notes from my first uro who I forced to transfer to him ("NO PEYRONIES") and probably something on there about my ailment being in my head as he told me repeatedly...  Obviously now he thinks otherwise.  I will try to e-mail Dr. Carson tomorrow as to the possibility of either moving my ultrasound up or having someone else at a different practice administer it.  

[ocelot556]

This is a crosspost, kinda, as my post got swept up in the healthcare off-topic deletion. I don't remember seeing anything about these two companies, and though they're just investigating anti-inflammatory and antifibrotic medicine for other maladies, we know that the jump (as in pentox or pirfenidone, etc.) can be made from drugs meant to treat more difficult diseases to ours.

So, has anyone heard anything about these companies? Or can they glean something I can't from reading them?

http://www.bio-medicine.org/medicine-news-1/New-findings-3A-The-anti-fibrotic-mechanism-of-plant-extract-Cpd-861-18031-1/

http://www.canfite.com/

[Tim468]

I don't know much about either of them. Will try to look at em later.

Tim

[George999]

I have found Chinese herbs in general to be pretty elusive.  I have little doubt that they work, its just that it is nearly impossible to procure them and know that they are safe and contain only what they claim to contain or that they even do contain what they claim to contain.  - George

[Tim468]

Given the changes currently underway in China, I am even more suspicious. IT is easier for someone to market a "miracle herb" or pill, and mix in some black market Viagra, and charge an arm and a leg for it, than for them to actually go to the trouble of harvesting the real thing and preparing it properly.

Tim

[ocelot556]

But given that there's a statistic that supports that most new compounds come from plant extracts/combinations taken from the amazon (yes, there's a stat for everything I know) would it be so far off to suggest that there are Chinese medicines that might have helpful effects to the degree of aloe vera naturally? Maybe I'm being overly optimistic, here.

The East has a very different way of approaching medicine, however, so I imagine most herbal effects (assuming they aren't snake-oil) would be more on the preventative side than the curative -- preemptive/preventative care is a large part of eastern medical thinking,

[Tim468]

The Amazon is in South America, but that fact notwithstanding, the problem with Chinese herbs marketed for the West is that they are not regulated.

That is a huge problem with an eager population looking for alternatives to the traditional allopathic approaches of the West. It is an undeniable fact that much of what we ingest from China has been doctored or had additives put into it, never mind the lack of environmental regulations regarding pesticides etc. If I were in a traditional Chinese herb store speaking to an old wise practitioner of Chinese herbal medicine I would feel a lot better than if I were ordering something from the internet or Whole foods or similar.

Tim

[roadblock]

I am terribly anxious to hear from anyone who is currently receiving injections in the Xiaflex Peyronies Disease trial. 1/3 of those people will be receiving placebo treatment, so we should keep that in mind. However, I know I would be extremely encouraged by even one person with a dramatic result so please if you are lucky enough to be enrolled and receiving therapy right now tell us about it!

[jackisback]

I would think that there would likely be prohibitions placed on those involved in the trials from writing about it before data has been compiled.

[j]

jackisback, that might be true for the doctors but not the patients.  During the last Xiaflex trials for Dupuytren's Contracture, people described their results in detail on a DC forum that I follow.  And those results were good.  Peyronie's of course is different in some very significant ways, so there's no guarantee Xiaflex will be as effective, at least not without some experimentation and refinement of the treatment.

Unfortunately the cost of these FDA-mandated trials is so enormous that they're something of a "moon shot", i.e. the company gets one chance and if they can't show immediate success, they're likely to tank.  

[Iceman]

has anyone been on the xiaflex trials - LET US KNOW YOUR RESULTS PLEASE!!!!!!!!!!!!

maybe there should be a separate thread for this as this is a major thing!!

[Hawk]

...maybe there should be a separate thread for this as this is a major thing!!

Iceman,  This is the separate thread for developmental treatments.  Xiaflex and the trials are the primary thing discussed in this thread since developmental treatments are limited.  If we took those out, this topic would be next to dead.

[Ticker]

Hawk,Iceman,I have been selected to participate in the xiaflex test.I am go to New Haven,CT.on Oct 29th.I will give you all the info I can.

[Iceman]

thx ticker....thats excellent - good luck...

[roadblock]

Ticker,

  That is great for you to be included in the trial! Please keep us informed regarding your experience and your progress.

roadblock

[Vernon21]

I'm am new to this site. I am in the xiaflex trials and have been injected.  I am still somewhat bruised and sore.  I don't want to get anyone's hopes up but I think it is helping.  I will know more in the coming weeks. I don't think its the placebo. I don't want to get too specific with information that might in anyway jeopardise my continuation in the trials. I will try to check in as I can.  This is my first post so I hope I am navigating and using this site as intended.

[newguy]

I'm am new to this site. I am in the xiaflex trials and have been injected.  I am still somewhat bruised and sore.  I don't want to get anyone's hopes up but I think it is helping.  

Thanks for much for your contribution. Please do keep us informed.

[Iceman]

VERNON21 - keep us posted - can you tell us how you feel and what improvement you have noticed and also how to get on the trials list.

[Vernon21]

Certain uros were selected by the drug manufacturer, Auxilim, to recommend patients of their for the trails.  Those recommended go through an extensive screening process before being selected. There are only certain specific conditions they were looking for.  The uros are what I think are the top ones in this field but I don't have a list.  I do know in the practice I'm involved in I heard there were  about 4 times as many men who wanted to participate as there were slots.  
I believe my erection is now somewhat straighter and the weak point has improved. I never had a high degree of pain during erection.  It will be easier to know more soon once the bruising has cleared up.
I hope this helps.

[jackisback]

You know how they give cancer patients drugs even before they've completed trials and data collection and official approval just b/c it's considered unethical to refuse it to a dying patient? if only they felt such a necessity for people with problems with their most prized possession.

[Iceman]

does anyone think that this will work:

http://au.youtube.com/watch?v=dN6eAr92mRo

he says that it works for 8 out of 10 people...

[jackp]

Iceman
Sounds like someone trying to get rich quick off Peyronies Disease. IMHO
Jackp

[Tim468]

Iceman,

It's lame. He has a video for the same surgery that everyone else does. Some use SurgiSIS and others use other tissue for grafting, but the surgery is the same. There is nothing new or interesting here.

Also, since you posted this in another thread, and no-one had much to say, that should serve as a clue that it is not too scintillating. I also don't think that multiple postings of the same post help the forum, and it is in fact against forum policy (though moving a post to a new area is OK).

Tim

[didi20031]

tim
I think you should have a short look on the video. It is not the vid about surgery that was posted in the other thread, but it's about stretching. I was wondering too if anyone here had experience with this.  

didi

[newguy]

tim
I think you should have a short look on the video. It is not the vid about surgery that was posted in the other thread, but it's about stretching. I was wondering too if anyone here had experience with this.  

didi

I believe that various forms of stretching do hold promise, but when the guy started mentioning ordering his video and clicking on the "buy now" button, it didn't really speak well for his credibility.

[ohjb1]

I am going to be in the Xiaflex trials and have been unable to get an answer to one question. Hopefully, someone from this group will be able to give an answer. How is anticipated that Xiaflex will work? Is it expected to dissolved the scar tissue or does it just soften it or is there another mechanism at work?  

[j]

Here's my understanding,  based on its use against Dupuytren's contracture:

It's an enzyme that breaks down the form of collagen found in Peyronie's tissue.  Its effect is local, and I think there' a possibility of damaging good tissue, so they can't just inject enough of it to spread out and dissolve all the bad tissue.  Instead they'll inject small amounts of it into the bad tissue so it stays confined there.  Beyond that I don't know what the plan is - I'm thinking there would be a number of injections, to break up enough of the collagen so that the bend is significantly reduced.

I hope the MD doing the treatment gives you a better explanation.  In trials for Dupuytren's it was found to be safe and effective.

[Vernon21]

Encouraging news

I'm in the trials and have been injected.  I'm fairly certain I got the real stuff.  After some of the swelling and bruising went away there is definately improvement. The bend is reduced and the weak spot (dent) is reduced.  I'm not 100% but back to what I would say is more in the normal range.  I'll take it!  I understand that if you improve past a certain amount the uro will not inject you again per the rules of the trials. I keep thinking the other shoe will drop and I'll return to the way I was, but I'm told it shouldn't.  

If there are others at this point in the trails, let us know how its going.  I hope we will be hearing other good reports. I'm thinking something really promising is on the way for everyone.

[Iceman]

vernon21 - AWESOME!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!! - SO WHAT IS THE DIFFERENCE YOU THINK??

[Angus]

  Encouraging news to say the least! Could you also post a kind of time line so we can have a record of how long it was before changes were noted? For instance, days/weeks/months, etc. from injection to noticeable improvement or change. There's a couple of thousand guys holding their breath on this one here.