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

[newguy]

Great news vernon. I'm really pleased for you. Let's hope the improvements continue

[Gregory]

Vern,

Can't tell you the how happy I am for you and for the rest of us.  I have so much hope invested in Xiaflex.  Keep us posted.

Greg

[j]

Angus, as I understand it, it works within days if not hours.  For Dupuytren's they injected it, waited a little while and then tried to snap the cord on the spot by pulling the finger straight. In many cases that worked; if not, they waited a couple of days and tried again.
 

[Vernon21]

Guys,

I will definitely keep you posted. I will be going back to the doc soon to determine if I'm getting another round of injections.  When you first get injected you are sore, a little swollen and bruised so it is hard to tell if there is immediate change.  It was after a few days and a more full erection that I noticed changes for the better.  I'll convey as much as a I can but don't want to do anything that might jeopardize my completing the trails.  I have no idea how things are working for others and would like to hear.  Things here look promising.  Auxilium stock has really dropped lately so I wonder if its just the bad market or if there are other issues.

Like most everyone else here Peyronie's was a real psychological kick in the stomach for me.  I'm fit and athletic and went from being proud of my old friend to being self conscious and unsure.  So far so good with the trials, there is real improvement.  Keeping my fingers crossed for everyone.

[Dusty Letha]

Hi.....


         'Good medical practice and the best interests of the patient require that physicians use legally available drugs, biologics and devices according to their best knowledge and judgment. If physicians use a product for an indication not in the approved labeling, they have the responsibility to be well informed about the product, to base its use on firm scientific rationale and on sound medical evidence, and to maintain records of the product's use and effects'.......

[jon]

Hi.....


         'Good medical practice and the best interests of the patient require that physicians use legally available drugs, biologics and devices according to their best knowledge and judgment. If physicians use a product for an indication not in the approved labeling, they have the responsibility to be well informed about the product, to base its use on firm scientific rationale and on sound medical evidence, and to maintain records of the product's use and effects'.......

yep, it's called off-label use. it's how most of us got prescribed pentox.

[Iceman]

could anyone else with Xiaflex experience post something here.........

[Ticker]

Iceman,I was screened yesterday for entry into the trial.The doctor told me that I was an excellent candidate.If the blood test and the EKG comes back ok,they will call me to schedule the first injection.I will keep everyone informed.

[seaside2]

I went to my GP yesterday for my annual physical. He has become interested in the treatment of Peyronies Disease and is looking at this site. Small victory. He also was interested in my somewhat modest success via the VED. He also is going to stop prescribing vitamin E, Potaba and verapamil injections. BTW, he also is becoming very cautious with Flomax as a result of side effects. Apparently there are many including the ones mentioned on this board as well as some talk of arrhythmia.

We talked about Pentox and he is willing to give it to me for a few months as a trail. Before I start, I want to find out more about side effects. I checked out the various web sites but wanted to get feedback from real people. I am 64 years old and have a mild form of type 2 diabetes. Otherwise very good health, except for this darn Peyronies Disease stuff

[Iceman]

Does anyone think that Obama will be proactive in Peyronies Disease research???

[Old Man]

Iceman:

I don't think that anyone really knows which way that Obama is going with the health care program in the USA. He has been all over the place with his ads about what he intends to do with the program.

Someone else in the States may have a better view point.

Old Man

[George999]

I really don't think that a change in President is going to effect medical research to any great degree.  Both candidates had promised to deal with health care issues, but I think when it comes to research, any real changes are going to be in the big hitter areas of cancer, heart disease, diabetes, etc.  Peyronie's research is a back water.  I suspect it will remain that way.  The REALLY BIG risks to Peyronie's research are not political but ECONOMIC.  If the US economy continues to go sideways, it could have dire effects on all medical research and could set Peyronie's research back years.  Lets just hope that Mr. Obama can get things going again soon.  That will not be an easy project, but he is a pretty sharp fellow and just might be able to pull it off.  We can all pray that he will.  - George

[Hawk]

We all in the U.S. need to remind ourselves of our Jr. high school civics class.  Presidents don't make laws.  Congress does.  The health plan may be influenced by a President but it will be developed under N. Pelosie, and H. Ried.  Obama is unlikely to veto anything they send to him.

[Hitman]

I'm expecting things to get worse. there is a wide ignorance of basic economics among the population and especially politicians.

[seaside2]

Does anyone think that Obama will be proactive in Peyronies Disease research???

Only if he gets Peyronies Disease with a 90 degree bend to the right.


Sorry, bad political humor, but I just had to. Shame on me!!!

[Old Man]

seaside2:

Don't be sorry. Ex-president Bill Clinton had a really bad and severe curve and did nothing about getting more attention drawn to medical help for everybody.

He could have gotten some research money and asked the medical community to advance studies, but didn't. Shame on him!!!!!

Old Man

[jackisback]

I don't think President Clinton's condition caused any kind of dysfunction, didn't seem to slow him down too much anyway.

I agree that the biggest risk is that the economy will have more problems that take a while to fix. I'm personally hoping my penis will be injected with Xiaflex within two years, and hard economic times could definitely prevent that. Whatever policy is set out for, it will be executed the way Obama wants it. His popularity is overwhelming, and his party will do what he wants in Congress.

I just read that he may reverse stem cell research bans very soon. This is a great thing for all diseases looking at it from a long term perspective, but I doubt the short term benefit will be too great too soon.

[Iceman]

i cant believe that there has been such a small response from people taking Xiaflex -
Cmon guys let us know whats happening with you ......!!!!!!!!!!!!!!!!

[Vernon21]

I'm in the trials and I have definitely made some improvement. I'm pretty certain I got the real stuff.  I will be back to my uro soon for an evaluation and to determine if I will continue with another series of injections.  I'm certainly not 100% but glad to be back into what I would call a more normal range.  I've tried to be pretty objective and not overstate my results but I really think they could be on to something promising.  I will keep you posted on where things go from here.  I'm really hoping some good news is on the way for everyone.

[Iceman]

thanks for that vernon21 - any other guys with xiaflex feedback  - also if these tests work well what timeline are we looking at for public usage???

[jon]

I'm in the trials and I have definitely made some improvement. I'm pretty certain I got the real stuff.  I will be back to my uro soon for an evaluation and to determine if I will continue with another series of injections.  I'm certainly not 100% but glad to be back into what I would call a more normal range.  I've tried to be pretty objective and not overstate my results but I really think they could be on to something promising.  I will keep you posted on where things go from here.  I'm really hoping some good news is on the way for everyone.

fantastic. I'm kinda jealous.
I'm also more than just a little upset that none of the test sites are anywhere close to me.

[roadblock]

seaside2:

Don't be sorry. Ex-president Bill Clinton had a really bad and severe curve and did nothing about getting more attention drawn to medical help for everybody.

He could have gotten some research money and asked the medical community to advance studies, but didn't. Shame on him!!!!!

Old Man

Old Man, where did you get this info re: Ex-president Clinton? Is that true??

[Old Man]

seaside2:

I am a counselor for the ACS in my home town and as such have to be sponsored by a uro group. They refer patients to the ACS for counseling when needed.

One of the doctors in this group was a navy doctor/surgeon at the Naval Hospital in Bethesda, MD. While on active duty there he had occasion to examine the ex-president and he knew first hand the extent of the curvature, plaque and nodules, etc. He told us about this during one of our training sessions.

Old Man

[jackisback]

Isn't that a breach of doctor/patient confidentiality or something?

[Old Man]

jackisback:

Not if he did not actually say his name, but only referred to him with enough suggestions that we figured it out.

In addition, there have been other posts on this forum indicating the Pres. Clinton had Peyronies Disease.

Old Man

[George999]

Actually, the issue of President Clinton having Peyronies Disease has been in the news in the days since the Monica caper.  So it is definitely not secret information.  In the midst of that kind of scandal, these kinds of things tend to leak out.  - George

[seaside2]

Gee, I was actually referring to Obama's politics and making a joke about anything that appears to be right wing, even his penis. At the same time, I strongly suspect that if he had Peyronies Disease like many of us do, he would be all over the funding issue!!!

[Ted Williams]

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...

I have actually written to Dr. Herazy on several occasions.  He seems like an honest guy looking to help those of us with Peyronie's.  I used his nutriceutical products aggressively.  I have been seeing a slow change and improvement.  The bend has decreased and distal rigidity has returned.  I am going to continue this method of treatment so that I will be ready when Xiaflex comes out.  I theorize that the surrounding tissue of the scar is invaded by collagen as well and taking the products he offers helps me reduce the total infiltration of the tissue.  I will either get to a total cure by the time Xiaflex comes out, or I will reduce the scar to a very manageable point.  My scars have shrunk.  

Good to read about success with Xiaflex... I like most people will fly where ever I have to go to handle this problem.  

Ted

[Ted Williams]

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?  

So here is how I understand it works.  Collagen that forms has cross links that draw the material together at a molecular level.  Think of this product as highly specific meat tenderizer.  It has a chemical reaction in the collagen that cleaves the cross links that cause the material to become this insufferable lump and allows it to soften/disappear.  It is suggested by some literature that the enzyme is able to distinguish between the required collagen that deposits to fix an injury and the over expressed proliferation of collagen and fibrin that comes in a man with Peyronie's.  I am very hopeful for this product.  The literature and science behind it makes alot of sense.  Floating around in the WWW is a video of a man getting injections into his hand for Dupuytren's Contraction.  He is able to open his hand significantly after his Xiaflex treatment.  I'm encouraged!  

I come from a Pharma background and I know one thing that always occurs in a study is they set the bar as low as they can go for clinical success.  They seek to "soften" the scar, not dissipate it.  I suspect that the results from this therapy may exceed "softening" the scar.  The video of the Dupuytren's patient describes a full rupture of the nodule and a return of the hand's flexibility after physical therapy.  It may be that the stretching techniques along with Xiaflex along with the appropriate oral therapy to clean up the remnants of collagen after Xiaflex does its things will be a path to success.  That is what I am going to do the minute Xiaflex is out.  

I am a fan of Dr. Herazy as well.  I write to him and have had success using his suggestions for Oral treatment.  I believe it works from my own experience.  While I am not cured, I am encourage.  

[George999]

I pretty much agree with Ted's observations regarding Xiaflex and how it works.  Thanks Ted for that contribution!  In many cases it is just a matter of breaking a single metabolic logjam and from there on the body is able to resolve things itself.  The hard part is identifying the logjam and finding something to target it.  It really sounds like Xiaflex is a winner in this regard.  Already I am hearing of increased investment capital becoming available as potential investors are starting to get excited about the prospects for Xiaflex successfully treating Peyronies.  I think that is pretty amazing in and of itself.  - George.

[didi20031]

Ted

Could you please post which kind of oral treatment Dr. Herazy suggested to you? It may be of help even for others here in the forum!

Thank you in advance!

Cheers

[jackisback]

Ok, so I know this is simple, since there are trials now for Xiaflex (peyronie's) in Phase II, those are the Phase II trials, yes? And then would there be Phase III trials after that? And how difficult would it be to get in on those trials?

Xiaflex for Dupuytren's is currently due for release in 2009 according to some news from google. Ah, if only we could get some black market Xiaflex

[Vernon21]

I heard  that if Xiaflex is released in 09 for Dupuytren's some doctors will most likely use it for Peyonies as an "off label" use.  

[Iceman]

where did you hear that???

[Ted Williams]

Hey folks:  Here is the break down of the phase trials.

Phase I is designed to assess safety and tolerability of a drug.  In this phase they make sure the drug doesn't kill anyone and they figure out what the range of a dose is for efficacy and tolerability.  Basically, how high can they go before they kill'ya.  

Phase II is designed to assess if the drug works.  Safety is further assessed.  
Phase IIA is designed to determine dosing.  
Phase IIB is designed for efficacy at specific doses.  

Phase III is a randomized double-blind study for efficacy in comparison to the standard of care.  In the case of Peyronie's, there is no real standard of care for which you can compare.  If you were studying headache medicines you would compare it to aspirin.  

So phase III will be another study that will compare to another therapy.  It will absolutely include the exact same dose and protocol that the Phase II, Phase IIa and Phase IIb studies included for all patients that were injected with Xiaflex.  That way, when the studies are done, they can say, "We've injected " +/- 10,000+ men and we get SUCCESS!!!"  It is part of the strategy of setting up your future marketing so you can maximize success.  This is a business.  So basically, when they show success in the Phase IIb, they will immediately start a Phase III that takes almost the exact same time as Phase IIb takes to complete.  Why?  Because they will just do the exact same thing again, except this time they will have the standard of care, in this case, maybe a verapamil shot, or maybe a saline shot followed with an oral dose of vitamin E and then they will compare.  

To answer "IceMan's" query... Doctors can ABSOLUTELY prescribe medication off-label for a condition.  The drug companies just can't market it for such use until it has been approved.  It is a delicate dance.  Doctors will frequently prescribe drugs for something that has absolutely nothing to do with the indication... that is how doctors are injecting Peyronie's plaques with Verapamil.  So I believe that once the Dupretyne indication is passed, then I will run, not walk to any doctor who's name is published on studies for Xiaflex and Peyronie's disease and say, "ME FIRST DOC!!!"  But I am aggressive that way.  

didi20031 remind me to give you the regiment I used for treating Peyronie's with neutraceuticals... It is just late and I'm going to bed!  

[Iceman]

ted williams - when do you think we will be able to approach these doctors - what time frame at the earliest would this be possible in your opinion - can we just ring up a doc and make an appointment??

[George999]

Ted, Dr. Herazy is a big time proponent of Neprinol.  This is a very expensive product and Dr. Herazy has a financial interest in selling it, although, I have to admit his margins on other products have been very reasonable.  But I am really very skeptical of Neprinol in terms of potential benefit for Peyronies.  I took it for quite a long time with no perceived benefit.  But I would be interested in knowing if you took it and felt you were getting some benefit from it.  So far, I have never heard anyone provide credible first hand testimony as to Neprinol providing any Peyronies benefit.  - George

[Vernon21]

Should Xiaflex become available in 09 and used for peyronies on an off label basis, the skill of doctor doing the injecting is every bit as important as getting the real drug.  Remember this stuff dissolves tissue. A skilled uro and expert in peyronies that knows your specific tissue architecture as well as where and how to inject is vital.  If I've learned anything from being in the trails that would be at the top of the list.

[Ted Williams]

For George999 and didi20031:  

My experience:  

I understand anyone's concern that the treatment suggested comes from a person that is making money off of the sale of the products.  I am of the mind that no one does anything unless they are getting paid.  When I have corresponded with Dr. Herazy, his responses have been from a place of personal experience.  I believe him.  I am in agreement with the philosophy he suggests.  My Peyronie's took about 2.5 years to become what it was.  After 6 months of treatment with his therapy, I have seen it recede noticeably.  I have seen the plaques soften.  I believe it will just take time to get the progress I seek.  

Dr. Herazy has a web-site where you can read a lot about the "WHYs" of this treatment.  

See his web-site:  http://www.peyronies-disease-help.com/index.html

Morning:  Empty Stomach
2 - Nattokinase.
2 – Fibrozyme

Morning:  1 hour later with food
1 Vitamin E. 400/400
3 PABA

Afternoon:  1 Hour at least before lunch or 2 hours after lunch.
2 – Nattokinase
2 – Fibrozyme

Afternoon:  with food.  
3 PABA

Dinner:  Empty stomach.  I usually take it a few hours after eating dinner
2 – Nattokinase
2 – Fibrozyme

Evening:  with food
3 PABA
1 Gamma E 500.  

I have taken Acetyl-L-Carnitine in a 500 mg capsule
2 tablets in the A.M. with or without food, it doesn't matter.
2 tablets in the P.M.  
This is the most expensive of the bunch and I backed off taking it just because it cost so much, but I really should put it back into my routine.  

[Ted Williams]

Vernon21:  

I couldn't agree with you more regarding the choice of doctors for this Xiaflex procedure.  I have found video of patients receiving verapamil injections.  I can only imagine that in the wrong hands, a doctor could devestate one's progress.  Since you are in the trials your experience and opinions are very important.  

How are you doing now Vernon21?  Are you still feeling progress?  I am very curious to learn more about your progress/concerns/success.  

Thanks in advance for sharing your experience.  

[Ted Williams]

Iceman,

You asked when I thought this treatment would be available even off label... I just don't know.  I just keep checking in on the company's web-site to see what the progress is.  The approval process is long in the FDA unless Auxillium can get an "orphan status" for their product.  This is when the treatment is the only treatment for the condition.  It might be that they will get that status.  

Like you, I am waiting.  

[didi20031]

Ted
Thanks a lot for the interesting and detailed post. Maybe I will give it a try, if I can get nattokinase in Austria   The only thing is that I don't want to take PABA since my stomach is very sensitive (I have to avoid even things like coffee, onions etc.) and PABA is known to cause GI upset.
At the moment I am on Vit E, pentox, acetyl-L-carnitne and L-arginine.

Best wishes!

[Ted Williams]

Hey didi,  (George, see a follow up for you as well.)  

Too high a dose of vitamin E gives you the shits, if you don't take the PABA with water on a full stomach you do have acid burps.  I worked out both of those for my constitution and I was able to find acceptable, tolerable levels for both.  What I really found was that progress was determined by the softening of the tissue that made up the scar.  That is where I am at now.  

Most importantly, I try and avoid the negativity that comes with this condition.  The mind-body connection is real.  People do recover from this.  Good health, good nutrition and a good out-look can only help in the healing process.  I now live a very, very healthy life-style.  Little drinking, no smoking, elimination of white sugars, lots of leafy greens, and lots and lots of exercise.  My attitude is that I will over-come this condition.  My expectation is that Xiaflex will help.  

To follow up with George:  I believe it takes more than just Neprinol to make progress.  You have to get the enzymes to the site of the injury, and you also have to get your vascularity improved.  Nattokinase improves vascularity.  I would even include a little baby aspirin on a full stomach to get my blood flowing at a peek.  (If you nick yourself shaving however... it takes some time to stop the bleeding.)  On top of all of this is managing inflammation that is associated with the condition.  The synergistic effect is a result recognized through-out pharmacology.  Some drugs, in combination dramatically enhance the ability of other drugs to work.  Dr. Herazy's theory is that it is the same for Neutraceuticals in the treatment of Peyronie's disease.  

Take the time to ready Dr. Herazy's web-site.  If the philosophy makes sense to you, do it!  What do you have to lose, money?  I'll toss some cash at a chance for success.  If it doesn't work, no harm no foul... I live to earn another day.  

We could choose to be negative and seek failure, or we can be positive and seek success.  I want SUCCESS!!!  But that is just the way I am with everything.  

Regards,

Ted.

[George999]

To follow up with George:  I believe it takes more than just Neprinol to make progress.  You have to get the enzymes to the site of the injury, and you also have to get your vascularity improved.  Nattokinase improves vascularity.  I would even include a little baby aspirin on a full stomach to get my blood flowing at a peek.  (If you nick yourself shaving however... it takes some time to stop the bleeding.)  On top of all of this is managing inflammation that is associated with the condition.  The synergistic effect is a result recognized through-out pharmacology.  Some drugs, in combination dramatically enhance the ability of other drugs to work.  Dr. Herazy's theory is that it is the same for Neutraceuticals in the treatment of Peyronie's disease.

Ted,  Actually I was taking natto along with the Neprinol.  The Neprinol really cleaned up my lungs and seemed to be helpful for my joints as well.  But no discernible effect on the Peyronies.  But I most certainly agree with you on the point of managing the inflammation.  I strongly consider that to be the number one issue at hand.  Basically all of the other stuff you were taking (other than Fibrozyme (the original Neprinol) and PABA, I have also taken and found to be useful.  (If you scan over my past posts, you will see a lot of familiar products.)  And although I have never actually used PABA, I have always suspected it might be helpful in dealing with Peyronies.  I actually have an unopened container of it lying around.  That is how close I got to taking it.  Right now I have other fish to fry.  I was taking melatonin to help in lowering my blood pressure and got an inflammatory reaction to it.  So I am dealing with inflammation big time now.  The thing that is really helping me with that at this point is artificial sunlight, full body, for 20 minutes a day.  And it has had the effect of shrinking my inflammatory plaques rather dramatically in the process.  Most of the other stuff I have quit since I don't want anything to aggravate the systemic inflammation (ALC, interestingly, was doing that, although it was helpful with the Peyronies).  But I am continuing to take Pentoxifylline which is a major anti-inflammatory drug.  But your points are really interesting and an extremely useful contribution to the discussion here.  - George

[jackisback]

To answer "IceMan's" query... Doctors can ABSOLUTELY prescribe medication off-label for a condition.  The drug companies just can't market it for such use until it has been approved.  It is a delicate dance.  Doctors will frequently prescribe drugs for something that has absolutely nothing to do with the indication... that is how doctors are injecting Peyronie's plaques with Verapamil.

Thanks again for this reply Ted. This raises something very interesting which I was not aware of. You are sure that Verapamil is only administered to the penis as an off label function???  I was previously unaware of this.  My thoughts on off-label consumption has always been that it could only apply to oral medication. Since one group is using the medication for a different purpose, it doesn't matter in terms of side-effects, because both are taking the same medication the same way. However, I did not know that off-label drugs were allowed to be applied in different ways! Just because a drug that dissolves collagen is approved for injection into the hand would not take into account the very different potential side-effects of injecting into the penis. However, if you say that it was done before with Verapamil, then this is a really great precedent. If I found out that Xiaflex treatment would be available as early as 2009 off-label to the general patient.....well that would be the only Christmas present I need for this year and next.

To Vernon: you said that you had specifically heard that Xiaflex would be offered off-label. Where did you hear this, I wonder? I know you are taking part in the trials, so you can understand it makes a big difference if you actually heard this from someone involved in administering the medical trials, or if you just heard some speculation on the internet.

[Vernon21]

Jackisback,

I heard it from my doctor who is preforming the injections.  He is one of the top professionals in this field and an excellent doctor.  I will share more as soon as my trail is over.  It is my understanding that injectable drugs are also used for off label uses.  Botox originally had a different use and currently Gardasil is approved for women but it is being given to men as an off label use (the drug company is now working hard to be able to market it to men).

As I said before, if Xiaflex becomes available for dupuytren's in '09 DO NOT run out to any doctor that will inject you on an off label basis  Remember this stuff dissolves tissue!  I have learned the skill of the doctor doing the injecting is just as important.  He must be experienced, know how your specific tissue has formed, and where and how to attack it.  My doctor had used Collagenase in the past and knew what injection points would have the best effect for my situation.

As for my trials, I have had another round of injections.  The swelling and bruising has not totally gone down yet, but I am very encouraged.  I will share more once I have a better idea of the results. At this point I don't think there is any way I received the placebo.

[jackisback]

Did he seem to imply that it was a sketchy deal that less ethical doctors would start injecting it, or did he imply that the doctors in the top of their field would inject it (i.e. himself and the other doctors picked for the trials)?

Yeah, I definitely wouldn't do it unless I could get it from one of the well known, reputable Peyronie's doctors. Hopefully those guys will not be unwilling to do it!

[Vernon21]

Jackisback,

He did not say but my guess is that since he and others effectively used Collagenase in the past that top doctors in the field would not have reservations about using it as an off label use. I don't think the use of drugs on an off label basis by informed experts is viewed as questionable.  I won't see him for a few weeks but I try to make a point to ask.  Again, this is only a guess on my part.

[Iceman]

does anyone really think that xiaflex will happen or do you think that we will be back here in 12 months talking about it like with every other new whizz bang treatment or cure thats discussed - if its sooner and does work by some miracle , how does someone not living in the USA get there hands on it

[Hitman]

perhaps you need to travel to the USA.