Xiaflex

[nycsurfer]

Just had my first two shots on the first round in the open-label study and everything went swimmingly.  No change in curvature though.  It's been a week.  Will keep everyone posted.

I also just started the modeling procedure.  Three times a day certainly doesn't sound like much.  When I asked the urologist he said to just keep it to that but am tempted to do more modleing plus my FastSize extender along with it.  Is anyone doing anything extra like VED or Pentos besides what they tell you to do?  (Don't want to do my Pentox because don't want it showing up if they do blood work at the end of this.) Also, do you guys try to do the modeling in an erect or semi-erect state?

Thanks for the help!  

N.

[Ben]

Modeling into an erected state is a source of trauma. I think we need more time to know what modeling technique is the more efficient.
Personnaly my choice should be stretching with extenders : light to medium tension applied for several hours. Hard modeling on a erected penis sounds risky to me.

[MikeSmith0]

I just came across this and am very perplexed:

http://www.worthington-biochem.com/CLS/cat.html

How is collagenase available through this website?

[ohno]

I may be mistaken but I don't think auxilium has anything but a patent to use collagenase for peyronies, etc. Collagenase has had other uses over the years.

[agent0]

i dont get it, did they add more chemicals to the injection or something so its safe to inject in the penis? if they just put a patent on it why isnt it out for the public yet?

[agent0]

is it possible for plaque to compress or encase a nerve? and will xiaflex damage any nerves?

[Woodman]

I had some questions reguarding Xiaflex. Iam hoping some of you guys that have been though the trails mite be able to ansewer.

1. If Xiaflex does work for you are the results permenant or will the plaques slowly reform requiring more treatments in the future?

2. If anyone has had pain or long term pain did the treatment help with the pain once the plagues reduced in size?

3. Did the plaque just reduce in size or did it disappear all together? Can you still feel the plaque that was treated? Do they still show up on the ultrasound?

4. If you had waisting at the plaque did it help reduce the waist or make it disappear all together?

5. Has anyone been treated that also had a Hypospadia " incomplete urethra from birth" that has been repaired by surgery in the past?


I really think this is where my future is going with Peyronies and trying to rap my head around it all. I am hoping it might finally be an ansewer and bring some relief.

[Fred22]

is it possible for plaque to compress or encase a nerve? and will xiaflex damage any nerves?

It is possible for plaque to compress a nerve.  I've had pain now for over 5 years.  When I discussed this with Dr. Christine (Urology Centers of Alabama) in a phone conversation, he told me that was probably what was happening and that even surgery would probably not help and could possibly make it worse...Same opinion from Dr. Milam at Vanderbilt.  Dr. Christine did say, of course, that he can't make a real diagnosis by phone, but told me that my best bet may be to see a pain management doc...not very encouraging.  I'm scheduled for robotic prostatectomy on September 22 and I'm curious what effct this is going to have on my Peyronie's.  My surgeon says it probably won't make the pain any better or worse, and like every uro I've talked to, added it's "very unusual" for pain to persist for this length of time...lucky me!....Fred

[yyy]

Hello.
Do you thinks Xiaflex can be suitable also for a plaque caused by a Nesbit procedure and not necessarily by Peyronie disease?

[Ben]

yyy yes because both are made of excess collagen.

[Gap]

I just discovered that there is a doctor near my house that is working with Xiaflex. If I have calcified plaque, do you think this might work?  

[Worried Guy]

In the UK you are not allowed to participate if the plaque is calcified. It would be impossible to inject into bone.  

[Gap]

Well, that sucks! Thank you. I think I am going to schedule a consult with Dr. Lue.  

[pvpey]

F~@< me! Glad I read this. Martin Gelbard is part of my Urology group and my primary Uro had suggested I contact him months ago as he is supposedly on the cutting edge of Peyronies research sponsoring several different trial treatments regularly. I've been an idiot for not contacting him sooner, but have not been taking this disease seriously enough.

Diagnosed about a year ago. I'm probably about 15-18 months into the symptom stages of the disease. Found this site while my primary Uro was suggesting VI injections about 6 months ago after 4 months of Verap ointment. My situation is posted elsewhere on this site, but in a nutshell here's my situation. Late 40s with 30-40 degree dorsal curve. Still have full sexual function including climax, but positions with partners are limited. On 10th month Verapamil 15%, no help with erection, but may have helped slow plaque hardening and decent flaccid appearance. However recent retraction into foreskin and possible upper level hardening is a big concern.

Met a great teacher on this site "Old Man" who suggested VED treatment. Went on daily 5% Cialis, continued use of Verapamil 15% topical along with VED use 3 times daily. Not a candidate for Pentox having A-Fib and taking Coumadin. Had to cease VED being Cardiologist felt could cause additional damage and bleeding at penile base due to Coumadin usage. Cialis usage also caused erections when simply walking in grocery stores. All bets off and became very discouraged. Leaving site because many stories seemed hopeless and depressing while hoping for the so-called miracle cures on the near horizon.

I'm back today and intend to contact Dr. Gelbard immediately. Due to other issues have been taking (stroke) chances and off Coumadin for almost a month now. Have heard Xiaflex causes very painful initial penile pain, severe bruising and inflammation, but if the end results are worth it, I'm in. Will see what other options available including this new enzyme therapy after consulting Dr. Gelbard and will report. May also go back to VED therapy for the time being as well. As per Doctor instructions I still need to have sexual relations and masturbate regularly (daily)

Being still pretty new and naive to this disease I have no idea what degree of calcification constitutes bone growth, but I do know that bones don't bend or are pliable. Although my affected areas seem hard, they are still more in the gristle state (for lack of a better description) than that of bone. Thus I think now is time to make a move forward.

 

[Old Man]

pvpey:

You know what is best for your therapy based on your doctor's knowledge, etc. But, I firmly believe that VED therapy when used in a mild or moderate manner will not cause any further damage to you. So, if you do resume the VED therapy, just use a very mild erection state each pumping session. Less is much better in VED therapy than more, so try to observe that if you start up again. DO NOT OVERPUMP THE VACUUM AT ANY TIME!

Let me know if you have any questions about using the VED. Will be glad to assist in any way.

Old Man

[MikeSmith0]

Gelbard was the pioneer of collagenase (xiaflex)...since 1980, at least.  I think he holds the patents and AUX licenses it...not sure...or the patent expired...but he did the original work 30 years ago (yet still no treatment):

http://www.mendeley.com/research/collagenase-for-peyronies-disease-experimental-studies/

Please post here if you see him and let us know what he says... i assumed he retired by now since everyone just mentions levine, lue, and mulhall...but gelbard did a lot of the original collagenase work.

[ppain]

This newer patent seems hardly to advance Dr. Gelbard's method, which was also patented.  Yet Dr. Gelbard is generous toward Xiaflex where he mentions it in his website http://www.peyronies.org/.  

[pvpey]

Well I guess you might consider me one of those "newer patients", but after taking the time to visit Dr. Gelbard I finally see a light at the end of the tunnel in a positive direction. I only wish I would have sooner.

I'm not shy when it comes to explaining my condition, concerns and the discussion of alternative treatments in graphic detail with my physicians, but if you are, Dr. Gelbard will put you at ease immediately. This man is an expert and specializes in Peyronies.

As he'll tell you, this is rarely a disease, but scarring usually caused by trauma to the penis. And it's different in many cases, but alike in many as well.

We had long discussion in his office of my options, but the first was to determine if there had been any calcification in the large plaque area on the top of my penis causing a 30-40 degree dorsal upward curve. Luckily for me, x-rays showed negative thus I am still a candidate for all treatments available. If not, some sort of surgery would have been the most successful option. And the options he had illustrated before the x-ray were not very desirable to say the least.

He is a big supporter of Xiaflex although confirmed that the side effects can be like getting a low blow from Mike Tyson with a sore and black and blue member after treatment. But it shows the most promising permanent beneficial results in his opinion. Unfortunately for me all current trials were filled, thus I'm in limbo land until approved (maybe a few years yet). Or another trial becomes available.

For the time being I'm on a regimen to prevent further damage and any calcification I'd imagine taking Pentox and Colcrys (daily) with 5mg Cialis every other day. I return in 2 months (with pics of erect member sent prior) and we continue from there. I'll report.

[fubar]

I do not know what colcrys are but the rest sounds like a deal!

Fubar

[Luciano]

I do not know what colcrys are but the rest sounds like a deal!

Thats what I found:
Colcrys (colchicine) affects the way the body responds to uric acid crystals, which reduces swelling and pain.

Because colchicine was developed prior to federal regulations requiring FDA review of all marketed drug products, not all uses for colchicine have been approved by the FDA. As of 2009, Colcrys is the only brand of colchicine that has been approved by the FDA.

The Colcrys brand of colchicine is FDA-approved to treat gout in adults, and to treat a genetic condition called Familial Mediterranean Fever in adults and children who are at least 4 years old.

Here in europe docs are very jesitant to prescribe colchicine as it does have side effects..

Luc

[agent0]

so if xiaflex get rid of the scar tissue will the penis get smaller?

[james1947]

From reading the forum, especially the topics related to Xiaflex trial I think Xiaflex will make the penis longer and increase girth.
If you have a bend of 60 degree and dissolving or softening the scar tissues reduce it to 30 degree, simple geometry will prove that you gain length.
If the scar tissue is dissolved or softened, the blood flow will increase in the area and will make the penis more full, increasing girth.

I may be wrong, but reading the results people are posting, make me to think in this way.
Let's be positive and wait the final results.

One more think if you will be on Pentox, VED, etc' before Xiaflex, in my opinion it will help also.

James

[Luciano]

Just a note,
while i was surfing I stumbled into a forum where Dr. Gelbhard was anwering questions of users.
Most question and answer wont really interest people here because the concern basics about Peyronies Disease.

But one drew my attention, here the question and answer:

Any progress found on the use of Xiaflex which is now in a clinical trial for use with Peyronies? It has been successfully used foe Depuyten's ( the curving of fingers).

Clinical trials are ongoing at this time.  A report on the first phase of testing will appear in the Journal of Urology in June of this year. MG

So the results of the trial will be published in June? or has it been postponed?
It looks as this post was from february this year..
Luc

[james1947]

I will quote bellow my finding regarding Xiaflex:

Auxilium Pharmaceuticals Inc. Partner : Pfizer (E.U.)

James E. Fickenscher, CFO, commented on the data reads for the Peyronie's disease phase II program. He stated, "We are expecting top-line pivotal results of 2 phase III, double blind, placebo controlled trials in Peyronie's disease in late 2Q of this year."
Source: Cowen Group Health Care Conference, 3/6/12.

As for march 2012, the results will be published in June that is late 2Q.

The other thing I find is that all the "Peyronie's" forums/blogs that in reality are web sites sailing one or other miracle products to cure Peyronie's are talking very negative about Xiaflex. Why? It will ruin they business!!!

Myself, from the results of our forum members, I believe that even if it is not a "silver bullet" will help significantly at least people that don't have calcified plaques.

James

[agent0]

does anyone know where i can get news about xiaflex? besides http://www.auxilium.com ?

[james1947]

Any information on the web regarding Xiaflex (google & yahoo search) is based on Auxilium releases.
I didn't find any not Auxilium based information.

What is encouraging is that leading drug companies including Pfizer are running to make agreements with Auxilium for Xiaflex. It show they see BIG market with BIG profit in sight.

Attached Auxilium presentation to they shear holders with explanation regarding Peyronie's.

James  

[jw1441]

Xiaflex phase 2b results are on journal of urology website

[jw1441]

According to headline under Auxilium at yahoo finance

[Luciano]

is this the real xiaflex study by auxilium?
the one in the journal of urology is:

Phase 2b Study of the Clinical Efficacy and Safety of Collagenase Clostridium Histolyticum in Patients With Peyronie Disease
by Martin Gelbard, Larry I. Lipshultz, James Tursi, Ted Smith, Greg Kaufman, Laurence A. Levine

here is the fulltext:
http://www.jurology.com/article/S0022-5347%2812%2900114-0/fulltext

And there is a press release on the auxilum homepage, giving a summary of the study.
http://ir.auxilium.com/phoenix.zhtml?c=142125&p=irol-newsArticle&ID=1693677&highlight=


Luc

PS: stupid question... the whole study only had 146 patients? in 3 groups? thats less than 50 people treated with the real stuff world wide???
I thought the xiaflex study by auxilium was bigger..
Like several hundreds treated ... hmm strange..

[james1947]

Right about phase IIb study, just 147 patients in three groups including placebo, but in study phase III that the results will be late June this year are participating more than 800 patients in two groups including placebo.
http://ir.auxilium.com/phoenix.zhtml?c=142125&p=irol-newsArticle&ID=1693677&highlight=

James

[Luciano]

Right about phase IIb study, just 147 patients in three groups including placebo, but in study phase III that the results will be late June this year are participating more than 800 patients in two groups including placebo.
http://ir.auxilium.com/phoenix.zhtml?c=142125&p=irol-newsArticle&ID=1693677&highlight=

James

Thanks for the info

[peterjackson]

I have had Peyronies for over 2 years now and thanks to this website and the information I gathered here, I am now pain free and have regained some of my lost size.

[LWillisjr]

I have had Peyronies for over 2 years now and thanks to this website and the information I gathered here, I am now pain free and have regained some of my lost size.

You've made several posts but haven't shared what your symptoms were and what you did to achieve improvement.

[James]

http://ir.auxilium.com/phoenix.zhtml?c=142125&p=irol-newsArticle&ID=1701869&highlight=

Interesting that even the placebo groups showed decreased curvature. Must be the result of injections disrupting the plaques

[james1947]

It is also my opinion as I have written before. It seems the needle effect punching the plaque and the stretching the following day (or two) is a part of the treatment effecting not less than the drug itself.

James

[AphexTwin]

Anybody heard about this?  

[james1947]

The simple way to find some information regarding a subject is to make a search of the forum, the main page.
I get the links bellow:
https://www.peyroniesforum.net/index.php?action=search2
Xiaflex is the highlight

James

[Hawk]

It is well known and discussed here.  The trade name is Xiaflex.

[LWillisjr]

I had my annual check up with Dr. Levine yesterday. All is great by the way since now 4 years post surgery.  :)We got into a discussion on Xiaflex and I thought I would share his comments here. I wasn't taking notes, other than mentally so will try to accurately restate his comments.

1. Levine has been presenting lectures on the phase three results. But he added that Auxilium has not released any actual statistics of the number of men who experienced positive results from the trials. I asked Levine what the parameters of a "positive result" would be. Levine said in his own studies, he only counted men that had a 10% or greater improvement. But he said Auxilium will count ANY improvement whatsoever. [My thought...... When the actual results are released they might be slightly over stated based on this approach]

2. Levine did say that even though the actual number of men who saw improvement has not been released, but that Auxilium is reporting some overall average statistics. Those that did show improvement ON AVERAGE had an improvement of around 20 degrees.

3. Levine stated that he knew of a patient that saw as much as a  60 degree improvement. [My thought.....  if a few people realized this much improvement, then many more would have a much smaller improvement in order for the whole control group to average 20 degrees overall (see point 2)]

4. Xiaflex is not going to be the magic cure. Based on the comments above there would be a small number of men who could see a significant improvement. While many others would experience a very small improvement.

Maybe some of this is not new to anyone, but wanted to pass this along.

Les

[MUSICMAN]

Well for a few of you that have read some of my posts, I'm still around. This disease is very traumatizing even after having the improvement that I had. Please read my post under improvement/ success. As to some thinking that needle and modeling making improvement in the Xiaflex placebo group, I don't think so. In the first trial I was in I received the placebo and received no improvement. In the trial that I received the real drug I felt the plaque snap as it broke apart. I can't feel much plaque, as before it was a big hard lump. In my opinion the Dr. administrating the drug makes a Big factor in the results. I think most of us are looking for a improvement with first a drug, a mechanical device, possibly some type of surgery, and the last being a implant. I know some will go with the implant, but for me it would not be what I would call natural. In time Xiaflex will be available. It will not have the same effect on all, but will bring some improvement for many.  Musicman

[james1947]

MUSICMAN

I had followed your posts from the beginning and I am happy you jumped in again.

In my opinion the Dr. administrating the drug makes a Big factor in the results.

I agree with you 100% and I have expressed my opinion on that in the past.
From the other side I do believe that the improvements in the placebo group was do to the doctor capability to stretch the plaque in the correct way.
I also agree with your sentence:

It will not have the same effect on all, but will bring some improvement for many.

Let's remember that Xiaflex is not a silver bullet, and don't forget that calcified plaques (like mine) were excluded from the trial.
Many of us have calcified plaques.

James

[BrooksBro]

MALVERN, Pa.
Dec. 27, 2012
/PRNewswire via COMTEX/

Auxilium Pharmaceuticals, Inc. AUXL, a specialty biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing and granted standard review status to its supplemental Biologics License Application (sBLA) for XIAFLEX (collagenase clostridium histolyticum or CCH), a novel, in-office biologic therapy for the potential treatment of Peyronie's disease (Peyronies Disease). Under the Prescription Drug User Fee Act (PDUFA), the FDA is expected to take action on the application by September 6, 2013.

For the full press release:
U.S. Food and Drug Administration Accepts XIAFLEX� Supplemental Biologics License Application Filing for the Treatment of Peyronie's Disease - MarketWatch

[MattFoley]

Thanks for posting that. Thank God they're moving forward. I only hope that the FDA is not going to wait that late in the year to approve it. Pray to God.

[james1947]

Thanks for the posting BrooksBro.

MattFoley, I think they were moving faster if someone in the FDA had Peyronies.

James

[MattFoley]

James, no doubt about that.

[DO]

When this company started clinical trials it excluded gay men! (as if they did not matter)!!! When I found a (New Haven, CT) urologist who participated in the trials, he asked me that would I be happy with just a 10% improvement! (my was at 53% curve down ward). He also told  so many negative things... I think he did not want me as a patient! Now I am being treated at Columbia Medical center in NYC. With Verapamil injections and with use of a pump 30 minutes a day and the andro extender( 2-4hours per night) for the last 90 days, I have had a 30%  improvement. The painful erections are gone! Dr. Peter Stahl is so professional and good at giving injections, I am so lucky to have found him. I travel from Connecticut to NYC  every 2-3 weeks! He thinks another 90 days of therapy will be needed and I will follow his suggestion. If you could see how much 30% is compared to what it was ...it is major!
I have one question that I read on a earlier forum, one man said the if you do not use the extender the curve comes back? was this with or with out the injection therapy?

[james1947]

DO

Welcome to the forum and thanks for the information.
Very few forum members had success with VI. I suppose that it goes down to the doctor capability (same is my opinion regarding Xiaflex).
I don't know about traction results, it is not available where I am living so I can't use it.

James

[UK]

I have one question that I read on a earlier forum, one man said the if you do not use the extender the curve comes back? was this with or with out the injection therapy?

I used the extender for 4-5 months averaging 6 hours a day I recall. I saw improvement I could have lived with, however after stopping as it became not possible with my life, my improvement reversed considerably. This was without any injections. With benefit of hindsight I would have maintained some usage 2-3 times a week for about 1-2 hours. Hope this helps.

[MattFoley]

UK,

Have you had a full panel of blood work done telling you what your lipid and testosterone levels are? I urge you to do so if you haven't already. If you have, can you please tell me what they are? Thank you and God bless.

[DO]

UK,

Have you had a full panel of blood work done telling you what your lipid and testosterone levels are? I urge you to do so if you haven't already. If you have, can you please tell me what they are? Thank you and God bless.
Yes sex hormone binding is 65, :DHEA 68, LH 8.1, Total testostrone free and binding 540, free testoserone 52.4 Lipid level is 79, HDL 43, LDL is 72.