Xiaflex

[newguy]

Thanks for the update Briden.  

[MedStudent86]

Briden,

Thank you for posting. Would you be able to e-mail Dr.Lue back, and ask him about a possible off-the label use of Xiaflex to treat peyronie's before it is done phase III clinical trials. That would be much appreciated, as I'm sure we'd all be interested in hearing his opinion on that as a possible option.  

[ComeBacKid]

Iceman,

Your inbox is full! Just in case you didn't know that!

Comebackid

[nemo]

I had a yearly follow-up with my urologist Friday.  He's never been very cutting edge on Peyronie's (he begrudgingly allowed me to try Pentox for a while but then wouldn't let me stay on it (for no good reason)).  However, he mentioned to me that "there's an injection in Phase III trials now that they're having some luck with, and have had luck with Dupuytren's with it ..."  He couldn't recall the name (obviously not very helpful) but I assume he was talking about Xiaflex.  

Anyone know if he's correct about this or if he's off the mark?  I thought it still wasn't in Phase III? ...

Nemo

[BrooksBro]

So, at least one peyronies expert is not rushing to try it.  That tells me xiaflex is not something we can expect to see in the immediate future, if not years.  Until some studies are complete, no one can possibly know if it is effective or not.  I think the professionals call that evidence based medicine.  For me, right now, it is just another unproven treatment which "might" work, but we really don't know.  I eagerly look forward to seeing the results of any such study.  Meanwhile, my only choice is to continue with proven treatments.  :-/  

[UK]

Its worth waiting for Phase III results in my opinion. The improvement from Phase II to Phase IIb was from 25% to 32% (with modeling). Auxilium clearly learnt something about injection site, does and application. That was a 30% improvement rate of 7% between trials. Hypothetically applying the same rate of improvement between Phase IIb and Phase III - then we could see a further improvement of 9.6% or total improvement of 41.6%.
Starts looking a bit more interesting and viable as a treatment if that happens. Hypothetical but don't see why that couldn't happen. Irrespective if Phase III is starting October, 9 months of trials and 3 months for data - takes us through to October 2011, and earliest drug to market would be early 2012. If there is a doctor willing to do off-label he won't be benefiting from the extra trial data.

[MedStudent86]

My concern UK, and my push for it to be used off-label, is for newly diagnosed patients like myself. From what I have gathered in the literature, there is a critical time period 6-18 months while the Peyronie's is in the mobile phase, and the plaques are forming but have not yet calcified. Early intervention before the disease is permitted to progress fully, cause more curvature, and more damage to the tunica and other tissue in the penis is paramount in my opinion. For those of us who have just recently been diagnosed and who have a relatively mild case of Peyronies Disease, early intervention may save us a long recovery period before extensive damage is done to the tissues in the penis. In our case, 9.6% may not be a big deal, if we can intervene before the Peyronie's progresses further. This is of course my opinion, and something I'm going to pitch to my Urologist on my next visit.

Brooks mentioned that until the Phase III trials are complete, he'd just stick to proven treatments. My question to him would be, what proven treatments? There is not one single medication, device, or therapy which is FDA approved for the treatment of Peyronie's other than invasive surgery. Essentially ALL of the oral and topical medications that we use in the treatment of Peyronie's are "OFF THE LABEL" uses. We are using medications which were never designed or intended to be used for the treatment of Peyronie's, but which have measureable amount of efficacy in the treatment of Peyronies Disease. If a Urologist is willing to do it, I would have a hard time saying no based on the current clinical data.

Its worth waiting for Phase III results in my opinion. The improvement from Phase II to Phase IIb was from 25% to 32% (with modeling). Auxilium clearly learnt something about injection site, does and application. That was a 30% improvement rate of 7% between trials. Hypothetically applying the same rate of improvement between Phase IIb and Phase III - then we could see a further improvement of 9.6% or total improvement of 41.6%.
Starts looking a bit more interesting and viable as a treatment if that happens. Hypothetical but don't see why that couldn't happen. Irrespective if Phase III is starting October, 9 months of trials and 3 months for data - takes us through to October 2011, and earliest drug to market would be early 2012. If there is a doctor willing to do off-label he won't be benefiting from the extra trial data.

[ComeBacKid]

I think calcification takes a very very very long time.  Pentox studies have shown to reverse calcifications as well.  Xiaflex won't be ready for at LEAST a year, anytime before just isn't going to happen.  I'm not so sure the 6-18 month window is that important, but anytime you can get on a treatment as soon as possible you want to.  Most docs hand out vitamin E and tell you theres nothing you can do anyway.

Comebackid

[Skjaldborg]

there is a critical time period 6-18 months while the Peyronie's is in the mobile phase, and the plaques are forming but have not yet calcified. Early intervention before the disease is permitted to progress fully, cause more curvature, and more damage to the tunica and other tissue in the penis is paramount in my opinion.

When I had an appointment with male sexual health specialist Dr. Lue last year, he said calcification takes years not months. Although I am not a medical student or health professional, my conversations with Dr. Lue and my layman's understanding of the literature is that progression of the disease is not inevitable and that there are varying degrees of this disease. My hourglassing and minor loss of length are exactly the same 1.5 years on as they were just a week or so after my injury. Granted, I did start pentox about 5 months in so that may have helped slow any further progression. Not sure if I would want injections of Xiaflex early on though. Again, just a layman sufferer's opinion.

-Skjald

[j]

Based solely on my own experience, I agree that the need for early treatment, and the fear of calcfication, are both exaggerated.   Xiaflex can only dissolve or weaken existing plaque, it can't prevent it from forming.  

[MedStudent86]

Based solely on my own experience, I agree that the need for early treatment, and the fear of calcfication, are both exaggerated.   Xiaflex can only dissolve or weaken existing plaque, it can't prevent it from forming.  

This is true. However, and my opinion is just my opinion. There is so little data available about Peyronie's and the disease process (which is not fully understood) that it makes it hard to make 'predictions.' However, my major point was wanting to avoid damage to the tunica and surrounding tissues due to the plaque formation. While Xiaflex cant prevent plaque formation, logically I would think, that if we can break up/dissolve the plaques in the early stages, and new plaques form afterwards, we can break those up as well until the penis has healed the area without the pesence of the plaque, then we are steps ahead in keeping the tunica albuginea from undergoing extensive damage, as well as any other tissue in the surrounding area that may be affected. One would also think, if you can intervene at an early stage and dissolve the plaques as they are forming in the early stages, one can reduce/eliminate the loss of length and girth that occurs as a result of the plaques causing the tissues to become constricted and regress. I am not a doctor, so do not take my opinion as if it is coming from one. I am just basing it off of the current literature and information available to me, and what I know so far. I believe that early intervention in any disease is important, especially one which can have a significant amount of potentially irreversible damage to tissues which presently cannot be replaced. I am not advocating ONLY using Xiaflex, I think that the consensus on this board is that there are several medications which help to attack the disease process at several different levels, and I think that is a good approach, but I believe Xiaflex would be a good addition to an immediate attentuation of the curvature. Then drugs like Pentoxil can be used to prevent plaque formation, and VED therapy used to regain length and girth, as well as to remodel the damaged tissue.  

[MikeSmith]

I called auxillium about this... their number is readily accessible and they have humans answering the phone.  They explained all of the details, and I read between the lines for the rest.   The bottom line is that you cannot get xiaflex because they have limited the distribution channels - not because it's off-label.   This is the situation...

1.  Phase 3 trials have not begun yet for Xiaflex in men with Peyronies Disease.  Recruiting the sample, alone, will take several months - not to mention the trial itself will take monts + data analysis, etc... you're looking at 1+ years here.  Remember phase 3 has to be much larger than phase 2...so it's gonna be a while.  (Some of us might be eligible to be in phase 3 btw...not sure how many bc I think calcified plaques disqualify you - but i could be wrong)  Then, the FDA will take 1+ years to review their findings.  Bottom line - Xiaflex will not be FDA approved for Peyronies Disease until 2013

2.  So, why does that matter?  Why not use it off label?  The person on the phone actually told me this before I even asked it, because apparently they must be getting dozens of questions about this.  They don't give you the real answer (which I will provide below - per my own speculation) but this is what they say:  You are ONLY allowed to get xiaflex if you are an orthopedic surgeon or surgeon of the hand who has completed a training course in xiaflex injections.  Orders from urologists or any other kind of doctor will be denied.  Every order is reviewed & every hospital site that it is going to is also reviewed.  They don't just cash the check & send it out.  (I asked, what if I signed a waiver of liability - but this was not a question she could answer... this was a largely scripted conversation).

3.  If you wish to pay out of pocket for 6 xiaflex injections, you will have to find a hand surgeon who will order it and then give it to a urologist who knows how to inject it (and it's extremely specific & has some complex measuring formulas for DP on the website - since it is reconstituted from a powder & you don't want to over-inject and dissolve too much collagen, etc).  This will cost approximately $18,000 - not counting the office visits.  And, the results are not guaranteed.  But it is unlikely anyone will find a hand surgeon who is going to order it for you & give it to a urologist.  And also,  if you submit it to your insurance, it will not be reimbursed since it is not approved for Peyronies Disease.  

So, why is Auxillium guarding this drug?  Well, the cynical answer is they are concerned for our safety their future profitibility.  If a bunch of doctors start using it off-label (and without the highly specific training needed -- which they cannot legally provide) and people with Peyronies Disease have negative reactions, then (a) that data will become public in the grapevine & possibly even in journals - leading less urologists to use it when it does get approved  (b) the FDA may consider negative reports of off-label use in the application process (b) auxillium may get sued for complications from xiaflex in Peyronies Disease if they happen - and it is likely to happen if 100s of urologists are using it off label who are not perfectly trained.  They don't want to be pulled off the market (e.g. vioxx) before they are even allowed on the market.   Also, if they knowingly send it to urologist offices (this drug doesn't get stocked at walgreens) then they are implictly saying "we can do what we want - screw the FDA".  Then, when this becomes public in a scandal like the Neurontin-for-everything controversy that happened in the late 90s, they will end up in litigation, like Parke Davis was (Pfeizer, their parent, lost $430 million...which is 1/2 of  auxillium's entire market cap).  Granted, the Neurontin promotions were completely insane & clearly illegal - so they deserved that judgement - but selling xiaflex to a urologist would really only send 1 message to the judge - and it's not "we thought the urologist was using it for DP!".

They are a very small company with ONE product that they want to charge a ton of money for, so they are watching it like a hawk.   Also, given their size, they may not have the capacity to produce the drug for DP and Peyronies Disease at this time (which is common with some new drugs - where doctor friends of mine have told me they have to go through similar hoops to get the drug - like certain things in neurology recently & oncology - hard to produce & hard to get).

Anyway, at the moment, it would likely be easier to get heroin and crack than to get xiaflex.  Even if you got a bottle, nobody would know how to inject it, since the measurements & process for the penis are not public (the DP measurements are in the training videos on their site).  The powder expires rather fast & also when it is reconstituted with saline, it is only good for <1 hr.  Last, only the doctors in the trial know what the theraputic dose is for injection.

Well, sorry to disappoint you all but I hope this clears things up.  If you read the posts here,  you will find one of the the very few guys on here that had xiaflex said it didn't work that well for him (he was not in the control group) & he went on to later have grafting & excision surgery.

Anyone interested in a technical / legal analysis of off label prescribing can read more here.  http://leda.law.harvard.edu/leda/data/638/Kaufman.html

Oh, and it looks like Auxilium grossly overestimated the population of people with DP and their stock just got hammered... So, perhaps they'll move their ass on Phase 3 for Peyronies Disease where they will likely find much greater profits.

http://online.barrons.com/article/SB50001424052970203296004575324902997001566.html?mod=BOL_hpp_popcomment

[ohjb1]

To MedStudent86
You mentioned the terms early intervention and Xiaflex. I was in the Xiaflex study and received the placebo.
Note that Auxilium specifically excluded those men recently diagnosed. I don't remember the exact time frame, but you could be not be newly diagnosed and receive Xiaflex in the trial. Whether the protocol will change we will have to wait.
 

[ComeBacKid]

I'm not to worried about the FDA, could they move faster?  Perhaps?  But eventually they will either clear the drug for use or not, I'd rather have them take their time and make sure its safe, I got loads of pentox upstairs to take until then, which is more proven to work than xiaflex.  Could they abandon the drug for peyronies? Perhaps, but they are pretty far into this now, but yoru right, companies don't create a product cause they feel bad about mikesmith, while some might, they also do it to make money.  To make money you have to have demand for a product or show demand to raise capital, in order to justify making a supply.  How can we help them show demand? Starting mailing to every urologist in the usa about the PDS, and encouraging patients to seek support here and sign up for an account.  By doing this we grow our membership, increase our credibility, and allow us to reach out to xiaflex and not be ignored, we also provide them with information they can show to shareholders that there is a demand for this product. Consdier joining the mass mailing project and getting involved today.

Comebackid

[Tex]

So now the question is how do I / we get notified to get on the phase 3 trials list?  Where do I sign up? Is there a waiting list?  Does my doctor need to sign me up? Thanks in advance

[ken]

I talked to my doc about getting in on the trial.  He said he would check and see if I could and how far I would have to travel, etc.  That was 6 weeks ago though and I haven't heard anything.

[Fred22]

I just talked to someone at Urology Centers of Alabama in Birmingham and was told that the Auxillium trials were scheduled to be conducted there.  My contact did not know the term "Xiaflex" but did say Auxillium, so I assume it's the phase 3 Xiaflex trials.  You can reach them at urologycentersalabama.com

[newguy]

Thanks for the info Fred. Let's hope that there is light at the end of the tunnel as far as Xiaflex useage for peyronie's patients is concerned.

[joe]

FYI, You can search for clinical trials on the government website: http://clinicaltrials.gov/

If you search for peyronies (http://clinicaltrials.gov/ct2/results?term=peyronies), the first result is the Auxillium trial (I believe that was Phase II) that is now completed.  It still shows the original criteria there.  I assume when Phase III is planned it will also be listed there.  There is a Botox study currently recruiting participants.  

[ComeBacKid]

We have talked about reaching out to Auxilium with a letter as part of our outreach campaign, what do you guys think?  I was thinking about the new year would be a good time to send one out, by then they should be well into the Phase III trials.  Seems like still a lot of lingering question marks regarding Xiaflex, it'd be nice to get some concrete answers for our members.

Comebackid

[GS]

What about if every man and significant other wrote a letter to Xiaflex just to let them know how many of us are out here.  It would only cost 44 cents a person and they might be surprised how many of us there are.

If you think it's a good idea, just post an address for us and maybe write a form letter for us to follow.  I bet we could overwhelm their PO Box.

GS

[Fred22]

What about if every man and significant other wrote a letter to Xiaflex just to let them know how many of us are out here.  It would only cost 44 cents a person and they might be surprised how many of us there are.

If you think it's a good idea, just post an address for us and maybe write a form letter for us to follow.  I bet we could overwhelm their PO Box.

GS

Great idea!  Who knows the address?

[fubar]

Gs

Sounds great ,Comebackid has gone to great lengths generating a letter for this purpose and sending it out.
I think creating your own letter describing your own suffering will bring a better response comapared to a form.To me looking at a form is just another number writing your own letter to Santa creates more emotional attatchment making your words stronger.

We are society and not just one.Combackid cannot do this on his own we have to come together on this.
I for one would like to see a fund created for research bearing our name Peyronie's scociety.To be used when there is a reputable research organization that we can vote on and accept as worthy to our cause.

Just my 44cents :fubar, if 4000 of us sent a letter total cost 1760.00$ .

[ComeBacKid]

Gs,

I like your creative idea of every person sending a letter to Auxilium, it would really send a message flooding their P.O. Box.  However with that being said, we couldn't even get 10 people to participate in our mass mailing project, asking everyone to send a minimum of ten letters out.  I wouldn't want to follow through with this great idea if only five of us sent letters, it would make us look like a joke.  I'd have to see a list with people vowing to send a letter.  If you want to send your own as fubar says, it can't hurt.  I just thought a general one from the PDS would be a good outreach sooner or later.  I'm open to any ideas at this point. Fubar, your idea sounds good, although I don't know much about how that would work for taxes, who would control the bank account holding our money, etc.  I know Hawk has said he has experience working on local government and possibly budgeting issues.  Perhaps he or an account could chime in and discuss how you would set this fund up, who would control it, what we would do with it for tax purposes, how would we give out money or grants, and to who, and who would decide, all of us? I would imagine such a fund would be a 503 c, non profit like our organization, wouldn't it just be like the pds bank account?  I don't think it would be a separate fund, it'd have to be through us.  I think some would be suspicious of asking for money.

Comebackid

[GS]

I may be over simplifying the issue, but it looks to me like you could just post Auxilium's address with a person's name to send the letter to.  Maybe you could also write a sample letter for us to use as a prototype.  Then we can all write our own letters and send them to Auxilium.

After we send our letters, we can post that we sent it and we would all know how many were sent.  Maybe you can set up a separate thread that we could just add our forum names to.  It would only cost 44 cents a man.  I know my wife would also send a letter.  She would like to see me cured as much as I would like to be cured.

I would also be more than willing to donate money to our cause.  Just let me know how you all want to proceed and I'll do my part to help.

GS

[ComeBacKid]

GS

I applaud your enthusiasm that we have been lacking for advocacy and outreach.  If you want go ahead and draft a letter to be mailed to Auxilium, we can try getting as many people to send one off as we can, but I don't think we will get enough people.  As for a fund involving money, I think we should hear from the administrators and the PDS Advisory board on that issue before we move forward with such a task.  Also other members, perhaps a CPA or someone involved in finance or accounting.  

Comebackid

[GS]

Quite frankly, I am probably not the one to actually draft a sample letter for our forum to follow.  I'm sure we have much better and more knowledgable people than me on this forum.

I'm guess I'm suggesting the advisory board draft an outline of simple bullet points that we can incorporate in our individual letters.  Also, we need to have some way to figure out how many letters actually get sent.

To all of our members; remember this:  Peyronies is not going to cure itself.  We need help from the drug/medical community and anything we can do to solicit that help is important to all of us.  Let us all hear your thoughts on the subject.

GS

[Fred22]

I can write my own letter if someone can provide me with the address.
Fred

[ComeBacKid]

GS,

Your absolutely right, we need group participation, peyronies will not cure itself.  Thats why I'm undertaking mailing the entire USA essentially for the mass mailing project.  Our lack of participation has been poor on the forum, and kind of disappointing to be honest.  Auxilium is working on an exciting product, I would hope your idea will generate more interest then has been shown thus far. Right now I am committed to finishing the mass mailing project and it takes up much of my time, keep in mind we also sent a letter to Dr. Atala which I sent as well. So we are reaching out.  I'd love to hear from the PDS Advisory board on this topic before we move forward.  Perhaps sending them a PM and asking them to contribute to the discussion would be helpful.

Comebackid

[ComeBacKid]

GS,

I wanted to point out that through June, July, and August, (92 days) we had 304 new members or 3.30 new registrations per day.  Our current average I believe is like 2.1 so our membership is up, I do believe the mass mailing project is starting to kick in at this point and increase membership, since we've been mailing since last October.

Comebackid

[GS]

FYI to all,

I thought I would do a little research on how the Xiaflex phase 3 trial is coming along, so I called Auxilium Pharmaceuticals today to check it out.  They have a toll free number listed on their website.   According to the lady I talked to, they haven't started phase 3 yet, but she thought they were close.  She didn't know how long phase 3 would last, but said they would be keeping us all posted through their website and it would be posted on clinicaltrials.gov.

She asked if I wanted to be on their mailing list and I gave her my name, address and phone number.  I really don't expect to hear anything, but if I do, I will certainly post whatever information they give me.

Bottom line...IMO,it's a complicated process and it's gong to take some time.  Another year or two?  No one seems to really know.  Keep the faith...I'm sure they are going as fast as they can...after all, they don't make any money from it until we are buying it.

GS

[ComeBacKid]

Good work GS!  Definately keep us posted if you hear anything, as I expected they are moving along, but it could be another year until this product is brought to market.  Your absolutely right, as far as I know they will not make any money until they bring it to market and sell the product, so they have an incentive to get it right, and not piss away money they raised through issuing shares.  What is their stock symbol do you know?  They probably are being cautious to make sure they get it right for FDA approval, if the study is compromised they'd have to redo it, I'd rather have them take their time and get it right.  

Comebackid

[bummedout]

Does anyone have any idea when phase 3 will commence?

[jayhawk]

I think within the next 60 days. I saw my urologist on Monday, and was asked if I was interested in participating, I declined.
Jayhawk.  

[starman]

I just completed the Botox trial (very pleased with the results) and the doctor at Baylor told me they would be recruiting the the phase III Xiaflex beginning in late October with the trials beginning after the first of next year.  They participated in the Phase II.

[ComeBacKid]

Can you go into a little more detail about how you were pleased with your results?  How bad was your curve before?  Did it improve?  Did you gain back any lost size if you had lost any?  Botox seems like a wild thing to inject into the penis.

Comebackid

[UK]

http://www.prnewswire.com/news-releases/auxilium-pharmaceuticals-inc-announces-initiation-of-xiaflex-phase-iii-studies-for-peyronies-disease-104692709.html

Our late stage global development plan for XIAFLEX will consist of four clinical studies and will be known by the acronym IMPRESS – The Investigation for Maximal Peyronie's Reduction Efficacy and Safety Studies.  There will be two randomized, double-blind, placebo-controlled phase III studies, which are expected to enroll at least 600 patients at approximately 70 sites in the U.S. and Australia, with a 2:1 ratio of XIAFLEX to placebo.  There also will be one open label study, which is expected to enroll at least 250 patients, at approximately 30 sites in the U.S., EU and New Zealand, and one pharmacokinetic study, which should enroll approximately 16 patients.  XIAFLEX will be administered two times a week every six weeks for up to four treatment cycles (2 x 4).  Each treatment cycle will be followed by a penile modeling procedure.  Patients will be followed for 52 weeks post-first injection in the double-blind studies and for 36 weeks in the open label trial.  

The trials' co-primary endpoints are the change from baseline in the Peyronie's disease bother domain of the Peyronie's Disease Questionnaire (PDQ) compared to placebo and percent improvement from baseline in penile curvature compared to placebo.  The PDQ will have at least three domains, which will include Peyronie's disease bother, severity of psychological and physical symptoms of Peyronie's disease, and penile pain.  Safety measurements will include adverse event monitoring, immunogenicity testing and clinical labs.

"We are encouraged by the clinical profile of XIAFLEX, which emerged from our earlier phase IIb clinical trial in Peyronie's disease.  XIAFLEX was well-tolerated and produced clinically significant reductions in both penile curvature and disease bother," said Dr. Jim Tursi, Auxilium's Vice President of Clinical Research & Development.  "Over the last six months, our team, in conjunction with the U.S. Food and Drug Administration (FDA), outside experts and men with Peyronie's disease, has spent a considerable amount of time and effort to refine the PDQ, which has now been accepted for use in the phase III clinical trials by the FDA's Study Endpoint and Label Development (SEALD) Division."

[ComeBacKid]

So bottom line is that this study won't begin until the beginning of 2011 and last most of 2011 with final results in the beginning of 2012?  At this point all phases of studies will be complete right?  So realistically this drug if it ends up working will be available in about a year and 5 months or so?

Comebackid

[BSSS]

I actually took the time to listen to the webcast.  It was basically pretty dry, esp. the part where investors call in at the end and ask umpteen questions.

I'd like more info on the effectiveness of the drug for sure.  According to their numbers: in phase 2b (already complete) patients receiving the drug had an inprovement in curvature from an average of 54.7% curvature to 37.2% curvature if they had 'modeling' done after the injection.

While that sounds promising, I'm not so sure it's gonna be the cure all to some with peyronie's. It'll be interesting to see what the difference is in improvement with more doses.

Nice to hope that it might be an alternative to surgery, but I think I'll wait till the final tally is in before I get any hopes up!

BSSS

[Woodman]

Modeling is when they manually bend the penis with there hands usually in the opposite direction of the bend or curves in ones unit. Some doctors try to do it after Verapamil injections too. I believe they derive the theory from that the injections weaken the plaque and the bending will or could break the weaken plaque helping to lesson the deformity.

[ComeBacKid]

From my experience trying to bend my penis and feeling the plaque, I don't see how this would work, but in conjunction with a VED of slow stretching and training the penis to straighten could.  I think the VED and xiaflex could be used in conjunction to get great results!

Comebackid

[newguy]

From my experience trying to bend my penis and feeling the plaque, I don't see how this would work, but in conjunction with a VED of slow stretching and training the penis to straighten could.  I think the VED and xiaflex could be used in conjunction to get great results!

Comebackid

They seem to favour Xiaflex and traction, but maybe that's down to there being more traction research at the time. Now that we have positive VED too, it's certainly something that could be considered I think.  

[ohjb1]

was in the prior stage xiaflex study. as it was explained to me is that modeling would help distribute the xiaflex throughout the plaque. whether this is an effective approach or just wishful thinking remains to be seen.

[BSSS]

looks like the next phase of the trial has been posted:

http://www.clinicaltrials.gov/ct2/show/study/NCT01221597?term=peyronie%27s&rank=1&show_locs=Y#locn

I've already emailed one clinic to ask about more detail.  Will post when I hear back.

BSSS

[BSSS]

Anyone know what their "remodeling" consists of? (technique and duration ?)

taken from the clinical trials.gov page:

the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature).  

[Iceman]

question - if I sign up to this trial will i get the real xiaflex or a placebo - what are the risks involved - if i get xiaflex has any one had any positive results to let me know and if they have had the placebo what has been the side effects - what is the risk involved here as its in my city and im interested.......

thanks

[BSSS]

it is interesting to see that the clinical trial stipulates that you are not to use  - nor have you used 2 weeks prior - any mechanical devices (traction, VED?) during the trial.

[ohjb1]

iceman. i was in the trial and had the placebo. This is a blind study. Neither you nor your dr will know who gets the drug or placebo until after the study ends. Assignments are made at random.

Of course, everyone is different, but the only side effect for me was some pain and discomfort and a badly bruised penis for a week after the injections.

No change in my conditon either way.  

[Chopsuey]

I just saw my urologist this week and he was able to get me enrolled in the study. I go back 11/22 for the initial evaluation. As long as I don't have any calc and my blood work is ok, they will start the injections. I hope I don't get the placebo.

[ComeBacKid]

This is now more than once I've heard someone mention not having calcification, meaning if they have it they aren't eligible for the study!  I wonder why this is, since we know even calcified plaque could be stretched by the VED, although it would take longer for sure.  And we know pentox can reverse calcification, I've seen some of this, but still have a "harder" than normal penis.  

Comebackid