Thread for Guys in Xiaflex Trial - Currently or Previously

[Humorous3]

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.

nycsurfer,

You asked if anyone is doing anything extra like a VED or Pentox.  As far as we know, none of us in the study have done so because every one of us signed a contract stating that we wouldn't.  In addition, to do so would probably change the study results whether you are getting Xiaflex or the placebo.  

I'm in the followup part of the study now.  It takes more than a week or two to get results.  The nurse will give you the "official results" at your next visit and it will be in degrees.  Since you didn't mention it, what is your starting curvature?  

You didn't mention if you had swelling and/or severe discoloration (purple/eggplant color) so I assume you didn't have that.  

Modeling is normally done in the flaccid state although it can also be done if you get a spontaneous erection.  You should have received a card with modeling instructions.  

I hope you will rethink doing anything extra.  

Humorous

[fubar]

I can understand one putting there's own logic behind study and wanting to do more.However to be fare to the clinical study and its results.One should follow it by the letter, so to prove its worth in a resolve to this deformity.

Look as time goes on damage is done! We have all had broken bones, cuts, and infection.To see is what  truly an effective remedy,  could be following the guidelines to a study.Do not mess around!

Fubar

[ComeBacKid]

NYCSurfer,

One round of shots may not be sufficient enough to do anything.  More importantly you want to finish out all the shots of xiaflex, then you can determine if you got the real drug or not, and if you did, if the drug worked or not.  I would then take a month off to let your penis heal and then start pentox.  I would highly recomend following the doc's protocol, you don't want to mess around with this, this isn't a gambling game, there will be plenty of time to take pentox or do the VED, peyronies doesn't move to fast, its a very slow progression, so slow you can't notice it, so its not an extreme emergency to start pentox.  I had peryonies for more than 5 years before I started pentox and still saw reversal of damage.

comeBACKid

[bentoutofshape]

I just completed the four injection cycles and first follow-up appointment in the double-blind study.  I live in northern California but because there are no test centers here, I commuted to southern California for the study.  Before entering the trial, I had Peyronies Disease for three years.  I'm now 64 years old.  The only therapy I had tried was a cycle of verapamil injections which had no effect whatsoever.  I was offered surgery by one urologist but didn't consider it.  As a result of the AA4500 trial, my flaccid stretched length increased from 13.5 cm to 15 cm.  My angle of (upward) deviation decreased from 44 degrees to 14 degrees, a very good result.  The first cycle reduced the angle from 44 to 29, the second cycle had no measurable effect, the third cycle reduced from 29 to 19, and the fourth and final cycle, reduced from 19 to 14 degrees.  There was the usual bruising and discoloration on three of the four injections cycles.  I did all the modeling as instructed.  Of course I am very pleased with the result and conclude I lucked out and got the real drug, not the placebo.

[Worried Guy]

Wow that's awesome and thank you so much for sharing that with us!  It gives hope to the guys on the trial who have had an injection and have seen no improvement.  They should not assume that the following cycle will not help.  In the UK there is no placebo and a few of the guys have noticed none to little change. The improvement in length is a bonus.  Does this improvement in stretched length translate directly into improvement in erect length?  Any help with girth or dents?  Great news once again you must be so happy!!!

[bentoutofshape]

I am guessing that an increase in stretched length (measured in the flaccid state) must go hand in hand with decreased angle of deviation since both must be the good result of increased elasticity where the plaque is/was.  No measurements were made in the erect state, and indeed it would be difficult to standardize such a measurement, but I would have to say that, subjectively, the length has increased.  I didn't have any problem with girth or dents (no "hourglass") so can't comment on that.  I do remain puzzled why there was the second cycle of injections had no effect while the others did, but perhaps it was a function of exactly where the injections were made.  Anyways, good luck ahead - I hope it works out for you in the subsequent injections.

[Humorous3]

I have completed Follow-Up Visit 2, which is at week 33.  This was the "simplest/easiest" visit since no blood was drawn and no injections were given.  All the Dr does during this visit is check the hardness of the primary plaque.  He indicated there was no change.  

The next visit is in nine weeks.  There will be an injection and curvature measurement.  

Humorous

[ohjb1]

I was in the peyronie study and did not have a positive experience.  One thing I noticed in the Auxillium literature is that they state there has not been any long term adverse events from treatment -and then they qualify it by adding to the statment - not due to the drug.  

This is not clear and I don't know exactly what they really mean.  

[MikeSmith0]

I was in the peyronie study and did not have a positive experience.  One thing I noticed in the Auxillium literature is that they state there has not been any long term adverse events from treatment -and then they qualify it by adding to the statment - not due to the drug.  

This is not clear and I don't know exactly what they really mean.

The Xiaflex prescribing information (on the market) also has vague comments about the creation of antibodies to collagenase and possibly other MMPs...and the long term effect of these antibodies is unknown.  

"Since the protein components in Xiaflex (AUX-1 and AUX-II) have some sequence homology with human matrix metalloproteinases (MMPs), anti-product antibodies could theoretically interfere with human MMPs"

I assume this isn't a big deal since it was approved?  But what will happen to people with antibodies to their own collagenase.  Wouldn't they be worse off long term?   Nobody really knows what ALL the MMPs do - and they are very complicated... so... it's really a vague / grey area.

[saramon]

Have just completed cycle 4, surprisingly the injections for this cycle were virtually painless which was a pleasant surprise.

Again some bruising and swelling but only about half as severe as last time.

As reported earlier, my cycle 3 injections resulted in a large amount of bruising and swelling which took about 10 days to subside.

The measurements after cycle 3 were 10° improvement in curve but no increase in length.

So starting from a 50° bend:

Cycle 1:  8° change, no change in length
Cycle 2:  2° change, no change in length
Cycle 3: 10° change, no change in length  

So curvature down from 50° to 30° but no change in length although I think I have developed a slight twist to the left but this just may be more apparent with the reduced curve.

Cycle 4 measurements due in about 6 weeks.

My personal perspective on the process thus far is:

Initially I found the injections painfull when the drug was being introduced into the plaque (a stinging sensation) which was getting worse each time until the bruising and swelling occurred after the 1st injection of cycle 3. Since that time the last 3 injections have been virtually painless.

The bruising and swelling would appear to be a tipping point in the procedure where major change occurs (in my case) so with this 2nd round of bruising I am optimistic that I may get another largish change from this cycle.

I have developed a sensation within my penis when it is erect, like something is in there and is a little tender from certain angles, the doctor did not seems to be to concerned about this when I reported it.

Not sure how effective the modelling is but I have found it to become a bit painful, particularly the bending against the curve so it might be doing something or is a result of the internal sensation (see above).

As I appear to be getting the real thing I can only recommend this treatmeant as a very viable alternative to surgery, this is only very early days for this drug and the results for me have been excellent and hoping to get further treatment if it is viable at the end of this trial to see if I can improve further.

Might be worth buying shares in this company although burned by biotech investments in the past.

Will provide another update after the next measurement session.

Thanks

[MikeSmith0]

A corporeal rupture has been reported from the xiaflex trial.  Additionally, serious cases of blistering have also been reported that have taken months to heal (unlike the 2 weeks in the original consent).  This was told to me as I was asked to sign a new consent form in the study - even though I had all my shots, they are telling us this now...I suppose it is necessary to tell us since we are staying in the study to get the real drug eventually.

The man with the tunical / corporeal rupture had to undergo surgery (lucky him) - I didn't get the details about who did the surgery - but I am sure Auxilium paid (per the consent).  The scary thing is that I would only want a very select few docs to do the surgery - and I'm not sure my study doctor knows about the extensive complicated surgery that people like Levine, Mulhall, and Lue, can do with grafts.  I doubt AUX gave this patient a huge choice of surgeons.  The sad thing is this patient now probably has a worse deformity and significant healing process, than he did before the trial. The other thing is that I really think this should NOT have happened.  Collagenase, when injected properly, shouldn't cause this.  I suspect this was due to poor injection technique, but this was not something I was told.  I do know someone in the Xiaflex trial whose doctor is terrible and just injects under the skin - not into the plaques.  He's had no results except very very bad side effects.  There's really no way to tell AUX what is going on at this study doctor's site because their view on patients is basically "what do they know"?  So, some doctors are not following the protocol and not injecting plaques directly or following other procedures.  I'd love to name names but I can't.  PM me if your doctor is like this.  I am curious if the same offender is doing this to multiple people.  

[fubar]

Mike

This sucks,  but someone is going to throw the dart.However giving injections one  can make a mistake.My docs send me to the lab and have blood drawn all the time.Some blow a vein amd i have huge bruises to show for weeks.So you are rolling dice with Any  injection .There are going to be causality no matter the procedure.

Fubar

[agent0]

when they give you the injections for xiaflex do they give you the injection in a erect state or a flaccid state?

[BSSS]

when they give you the injections for xiaflex do they give you the injection in a erect state or a flaccid state?

flaccid

[nycsurfer]

Just had my cycle #2 shots of xiaflex over the weekend... one each day.

The shots were MUCH more painful than cycle #1 and the bruising swelling is MUCH worse (me penis today looks like an eggplant,  jeesh...).

Will let everyone know once the swelling goes down whether things have improved.  They did not improve much at all (if any) after the first cycle of shots.

More to come...

[trevorrr]

Is Xiaflex being used on those who are stable only? any one in the acute stage involved in the test?

[Worried Guy]

In the UK study you have to have had peyronies for 1 year or more.    

[saramon]

Hey nycsurfer

I think the eggplant look is maybe a good thing, you might be pleasantly surprised with the next result.

regards
s

[MUSICMAN]

I would like to say that there is hope and there are miracles. I would like to state that my experience and condition is my own and as we know each man has a condition unique to them. Also any statements are of my experience and opinion and may not apply to others.  Many have been waiting for reports on the phase III trial using Xiaflex. I have waited until I finished my trial to share my results. I was diagnosed with Peyronies at the beginning of 2006. Due to the condition I was offered surgery as a way of treating my condition. I might have gone that route, but my financial situation would not make that possible. I did try some of the oral supplements and the ved, but did not receive any improvement. I became aware of the Phase IIb trial starting up and my doctor was one on the list for the trial. I was accepted for the IIb trial and finished it. I was one that received the placebo, but was told from the beginning that if I did I would be offered the open label ( real drug ) when the Phase III trial started. I started the Phase III open label trial in Oct. 2010 and have finished the trial as of Aug. 2011.

When I started the Phase III open label trial my bend was at 78 deg. to the left. This made sex impossible for me.  At the end of my trial I was at 10 deg. I gained back 4 cm in length and I feel my girth is back to my normal.

I have know idea when the drug will be approved or any idea of the cost. If anyone would like to send me a PM I will try to answer the best I can. I will make a post to the improvement section of the forum and give a few more details.

I would like to thank my doctor, his trial assistant and Auxilium for my miracle.    Musicman

[saramon]

Congratulation Musicman, your final results are outstanding.

Your experience really demonstrates the effectiveness of this drug and should provide a viable non surgical alternative for other sufferers.

Regards
S



 

[GS]

MUSICMAN,

This is exactly what what this forum has needed; significant improvement of a really severe curvature.  Going from 78d to 10d is OUTSTANDING, not to mention gaining back some length and girth.

Please stay with us here on the forum and keep us updated.  You have given us hope for a brighter future when all we typically hear is more bad news.

GS

[ronners]

I agree GS - this is Music to my ears Musicman and good for you for sticking the whole process out ... lot's of sad stories and negativity on the blog sometimes and great news to read about a drug that is working - and a man that has persevered ... now get out and enjoy that new toy!!

[restore]

Woo hoo!  Thanks for sharing!

[BSSS]

Congrats musicman! Good news for sure!

[shrout]

Great news Musicman! Your post is a ray of hope to all of us out here suffering from this largely hidden condition.

I too considered surgery, but decided against it. This news makes me think I might have made the right decision.  

Please make sure you keep us informed of how things go from here.

[BSSS]

little bit of an update:

over the past few weeks I've had my cycle 4 injections and my first follow up visit.

My cycle 4 injections did not go well.  I had a delayed reaction to the first cycle 4 injection and the reaction was bad enough that I wasn't able to receive the second one. I wasn't really happy with that, but I had little choice in it.

A couple weeks ago I had my first follow up and learned that I've had a total up to this point 15 degree improvement in curvature and a small gain in length. I also did notice a little hourglassing I hadn't seen before which I feel was due to the extreme reaction I suffered from the cycle 4 injection. I do feel that this might resolve though because I've seen healing from that experience. I thought I had suffered a ruptured vein then and to be honest still feel that's a possibility.

As to my curvature reduction, I absolutely see the improvement when erect. I'm really not far from where I was before Peyronie's curve-wise.  I did have some congenital curve...prob 25-30 degrees pre-peyronies, and am back to that level after the 15 degree help.

I honestly do not know what I received. From my reaction to it, I suspect I received the drug, but also saw that some placebo patients received 15 degree improvements just from the swiss cheese effect. Not sure when I'll find out, but the nurse seemed to think that an open label study might still be available for placebo receivers in this phase.  We'll see....

[Ben]

I've talk about xiaflex with a girl from a pharmacy. She was nice enough to call Pfizer and ask them when the drug will be available in France. According to the lab, in march 2012 the Xiapex (french name of xiaflex) will be available for Dupuytren. But nothing about peyronie's disease.
I plan to have an appointement with my uro and talk about him about off label use of it.

[fubar]

Ben

I wonder if your urologist will have access to xiaflex sense it is not approved for Peyronie's. Worth a try though. It would be great if he would help you,  good luck.

Fubar

[Ben]

Fubar
If I discuss with him about evidences that xiaflex can by worth to try I'm quite sure it will be ok for him.
I don't know the legal status in other countries, but in France a med. doctor can prescribe almost anything.

The only restriction I know is "primo prescription", which means that the prescription needs the be initiate by a hospital practionner, then can be followed by a generalist. Ritalin and metadone are example of it.

A demand for temporary autorisation of use (ATU) can be done too. It can allow a doctor to administrate to his patient a drug that has been withdrawed of the market, but in this particular case will be less bad than doing nothing.

Yes maybe 2012 will be the end of the world and the start of a new one who knows ?
well, have a nice day !

[UK]

Auxilium have taken specific steps to try to prevent the use of Xiaflex off-label for Peyronie's. Dont recall the exact details but it includes making it only available to certain groups of specialists that treat Dupuytrens and only after undergoing certified training. They appear to be taking precautions as part of the Peyronies trials to ensure no bad experiences come to the surface before full licensing.

[saramon]

Have now completed all cycles and 6 week followup.

So starting from a 50° bend:

Cycle 1:   8° change, no change in length
Cycle 2:   2° change, no change in length
Cycle 3: 10° change, no change in length  
Cycle 4:   0° change, no change in length

So curvature down from 50° to 30° but no change in length. I have developed a noticeable twist to the left as I now think the plague was pulling to the right (and keeping the penis somewhat straight).

Although I experienced a major improvement I am a bit disappointed that I didn't gain a greater improvement.

The Doctor said that he could not feel any plaque so he was successful in targeting that. The remaining curve and twist must be caused by something other than a large detectable mass of plaque. He does not use any ultrasound in the examination.

Next followup at 52 weeks I think.

Overall, erection strength is greatly improved, curvature reduced but the twist has developed. I would rate my result as a 60 / 40 success (personally) as the twist is a disappointing development and I am still missing about 2 - 3 Cm's of length.

I would recommend this treatment because as reported in other threads this is a fantastic non surgical alternative which can produce stunning results.

Thanks

S

[Old Man]

saramoon:

Good news about your results of the Xiaflex trials. Now might be a good time to add in the VED therapy since you seem to have been relieved of the plaque.

The stretching of the VED therapy should give you good results as the erectile tissue would be in a flexible state. However, I would wait a few weeks before starting the therapy. And, also I would suggest checking in with your uro to make sure he would agree with it.

Old Man  

[saramon]

Old Man

Thanks for that, I will definitely look into the VED therapy. Your suggestion as a followup would seem to be a sensible continuation.

I was wondering what the next steps would be as the doctor did not seem to have any other options or opinions at this time.

I find a reluctance for any imaginative alternatives to be offered by the medical profession a bit disappointing at times.

S  

[Ben]

There is something I don't understand with the xiaflex trial. It was said that the men with calcified plaque were excluded, and for me if someone could feel an hard plaque in the penis it has to be calcified isn't it ?

Xiaflex is designed to break collagen, and plaque are made of collagen, so i don't understand the inclusion critera of this study.

[LWillisjr]

The collagen buildup is also referred to as plaque and this can be felt. It is during this time period that Xiaflex is more apt to work and break down the collagen.

After 12 months or so the plaque can calcify. There are several theories on whether anything other than surgical removal can be done on calcified tissue. Men with calcification were excluded from the trials as Xiaflex is less likely to help in this situation. And of course the people running the trial would like to prove its efficacy and therefore want the "best" candidates.

[Humorous3]

I completed Follow-Up Visit 3 earlier is month, which was at week 42.  There was an injection and curvature measurement which was 30 degrees.  Since this was 5 degrees less than the last measurement (May 2011),  I have to revise my totals.  The total now is a 30 degree reduction (started at 60 - ended at 30 = 30).  So, averaging that over four cycles, that's 7-8 degrees per cycle (although in reality, there was one cycle where there was no change).  

The next visit is in ten weeks (week 52) and is the last one in the study.  They will draw a blood sample, there will be an injection and measurement, and I will complete three questionnaires.  After that visit I will be discharged from the study.  

Humorous

[Worried Guy]

Well that is very positive!  How do you feel about that?  Are you at a point where you can live with it?  

[fubar]

Worriedguy

The man is living with it,  and giving revue.I think that says it all.

Fubar

[BSSS]

great news humorous! Glad to hear you've had more improvement!

[Humorous3]

Well that is very positive!  How do you feel about that?  Are you at a point where you can live with it?

Worried Guy,

It is positive - 30 degrees certainly is much better than 60 and I am living with it.  However, it would be nice to get at least 15 degrees more.  They haven't announced the criteria for the next study yet.  (The one that everybody in this study who received the placebo will be able to participate in which I believe will start around next spring.)  If I meet the criteria I'll try to enroll.  

I strongly encourage any of you to enroll in that upcoming study (if you qualify) even if you have to go far from your home.  (There are a couple of people that drive several hours (one way) to participate in this study.)  Xiaflex really works IMO.  

Humorous

[fubar]

H3

I hope you are able to participate in the next study that would be great.The chance of further improvement. I wonder I'd they will include my area this time. I don't think I will be able to travel anytime  soon.

Still worth looking into!

Fubar

[ComeBacKid]

I want to comment on Ben's comment on the calcification, we heard this before, that if your penis is "hard" then its calcified and can't be reversed.  However, after about 7 years I went on pentox and my hard penis totally went soft again after 7 months of pentox.  Since getting off pentox my penis slowly hardened again and got worse over the course of 2 years, now I'm on pentox again, I will keep all updated with my progress.  I don't believe that calcification can't be reversed, cause I believe mine was, so I'm not sure if I agree with the premise of the xiaflex study.

Comebackid

[MikeSmith0]

I want to comment on Ben's comment on the calcification, we heard this before, that if your penis is "hard" then its calcified and can't be reversed.  However, after about 7 years I went on pentox and my hard penis totally went soft again after 7 months of pentox.  Since getting off pentox my penis slowly hardened again and got worse over the course of 2 years, now I'm on pentox again, I will keep all updated with my progress.  I don't believe that calcification can't be reversed, cause I believe mine was, so I'm not sure if I agree with the premise of the xiaflex study.

Comebackid

Scar tissue in the penis is hard.  My plaques are very hard but do not show calcium on the ultrasound.  Some are nearly as hard as bone, though there is no calcium in there...yet.  How much pentox were you on for 7 months?  I wish I could stay on that stuff but I get side effects.  Did you get any?

[ComeBacKid]

Mike,

I can't imagine I just had scar tissue, I had the hard stuff in my penis for 7 years before I started pentox!  Yes I get side effects which are:  Dry Mouth, headaches, increased sweating, delayed ejaculation time, difficulty breathing when walking up hills or steps, blurred vision etc...  Did you get any of those?  None of them are so overwhelming I want to quit the drug.  

When I was on pentox before I was on it 2 pills per day, and then 3 pills per day for about 90 days, then back to 2 pills per day, I saw significant improvement, like 80% improvement.

Comebackid

[MikeSmith0]

Mike,

I can't imagine I just had scar tissue, I had the hard stuff in my penis for 7 years before I started pentox!  Yes I get side effects which are:  Dry Mouth, headaches, increased sweating, delayed ejaculation time, difficulty breathing when walking up hills or steps, blurred vision etc...  Did you get any of those?  None of them are so overwhelming I want to quit the drug.  

When I was on pentox before I was on it 2 pills per day, and then 3 pills per day for about 90 days, then back to 2 pills per day, I saw significant improvement, like 80% improvement.

Comebackid

That's great... I had sleep issues (which turned into mood issues) and some headaches.  So, it was hard to stay on it.  I didn't get any results from a few months of it.  If i knew it would work 100% i'd just deal w the side effects, but there wasn't much change.  I didn't take it that long, though.  

[fubar]

Lets say pentox and xiaflex can break down collagen. What repairs the the dead tissue ( scarred) elastic fibers of the tunica ?It has to come from a cellular level.A healthy stem cell culture from that body part or what Dr. Alata is working on a printable organ.

I know its crazy but if you look on the net he started out wanting to conquer Peyronie's? Know he has grown bladders that are in humans and created urethra s for some.

He is probably the foremost urologist that would have interest in our disease and finding a cure.Blowing a balloon up every day wont rid the wall of the gum stuck to it.

Fubar

[ComeBacKid]

Fubar,

Did you send that letter to him, keep us updated.

Mike,

I have sleep issues to, it takes some time to get used to the side effects, thats why you dont start out on three pills per day in my opinion.  The thing is with the sleep issues, I can't say its all from pentox, sinc eI've been staying up until 4-5am before I was taking it.

Comebackid

[Worried Guy]

There are plenty of other pages to discuss pentox on.  

[fubar]

Worriedguy

You have made the only post today on the forum.Congratulations on your positive post!Yes it would be nice if everything was perfect I was there too at one time.The last year or so people have been posting everywhere. However I did try to get it back on topic mentioning xiaflex and collagen. Boath  words relating to this very thread.

Fubar

[ComeBacKid]

Fubar,

Worriedguy actually brings up a good point, it seems that our forum has grown a bit like a spider web, or the tax code... okay maybe not that bad    I think the forum would benefit from some more volunteer moderators since hawk, myself, and the others can't do it all.  How does the forum feel about this?  Does anyone else feel like we have to many topics?  I've gotten a few emails from people saying they belive there is to many topics.

Comebackid