Thread for Guys in Xiaflex Trial - Currently or Previously

[ronners]

" Armando Anido, Chief Executive Officer and President of Auxilium. "We believe completing the enrollment of over 600 patients at sites in the U.S. and Australia in less than six months speaks to the enthusiasm in the urology community and their prospective patients for a non-surgical treatment alternative. We anticipate reporting top-line results in the first half of 2012."

[newguy]

I received an email from somebody asking me if there are any new xiaflex trial opportunity in New York or Chicago, cleveland areas? Any idea? I guess it's a bit of a longshot. Should the current trial be a resounding success, what's the timeframe we're looking at for availability to the general public?

[MikeSmith0]

I received an email from somebody asking me if there are any new xiaflex trial opportunity in New York or Chicago, cleveland areas? Any idea? I guess it's a bit of a longshot. Should the current trial be a resounding success, what's the timeframe we're looking at for availability to the general public?

There are no trials open at this point. They're about to end, actually.

There's no way to know for sure about the approval date - but I tried to calculate it based on the dupuytren's contracture study.  Maybe the summer of 2013...give or take 3 mos.

[Kempenstein]

This morning I had an appointment with the David Ralph's number 2 (Andrology in UK) who was actually in charge of the Xiaflex Trial in London.

He said that the results of the trial were "very good" and he is certain Xiaflex will be on the market in the UK "next year".

The bad news is that he said it definitely would not be available on the NHS and when I hesitated a guess at treatment costing between one and two thousand pounds his response was "something like that yes"!

Oh and the other thing he told me was that it is not true that Xiaflex is not effective against all calcified plaque. He referred to "bone" against which Xiaflex could not be administered but that did not represent all calcification. He said subjects with any form of calcified plaque were ruled out of a trial but that did not mean they could not be treated when the drug is on the market.

[james1947]

Kempenstein
Thank you for the update. Encouraging that he says:

the results of the trial were "very good"

I like specially that your doctor says that Xiaflex will help calcified scar tissues also, as mine are calcified.
You have participated in this trial? If yes, what are your personal gains?
James

[Kempenstein]

Hi James

No I didn't get on the trial. In fact I was very unlucky and was on it but the Ethics Committee forbade Auxilium to take on any extra trialists at the last minute.

[james1947]

Thanks for the info Kempenstein
James

[BSSS]

Had my next to last visit last month w/injection for erection and exam. Not much change to report. Still @ about 15 degree improvement. Started at 45* and am down to around 30*.
The examiner reports he can't find the plaque via palpitation now.

I have noticed less of a 'crimp' in the unit when erect, but not where I'd like it to be. Guess any improvement is worthwhile.

Final visit coming up soon. Hope to find out if I received drug or placebo soon after.

BSSS  

[Kempenstein]

Sounds worthwhile to me BSSS.

15 degrees, or a reduction of a third, is very good surely?  

[MikeSmith0]

I'm sure it'll be approved...even if it gives less  than 100% improvement - it's better than anything on the market now.  As long as the risks are made clear, like they were in the study (penile fracture, swelling, etc.)  the FDA shouldn't have a problem.   Actually, I think they will need to be very clear about who had certain side effects because people in the trial did have penile fractures and other problems - the FDA will know this - so it better be clear in the prescribing information.  I wonder if the FDA will make them investigate why this happened.  Was it the doctor's fault, something about the dose, the plaque being too thin, etc?  

If we're going to end up using this, we need to be more informed & everyone's situation (i.e., penis and plaque size, plaque location) is different.  The universal approach to dosing and administration was probably necessary for the FDA - but I do not think it's going to be the right approach long term to maximize benefits while minimizing side effects.  A guy with a small dorsal plaque on a 4 inch penis should not get the same injection as a guy with a huge circumferential plaque on an 8 inch penis.   I think part of the supposed mystery why this didn't work so well for everyone (while fracturing the penises of others).  I'm not saying this is the whole reason - but I got the sense that nobody wants to talk about penis size in detail.  Yes - it's a sensitive subject, but it's better than dealing with major side effects from injecting gangrenous toxins into your penis.

For example, the entire volume (not just the length) of the penis should be calculated - in tandem with the estimated size of the plaque - to create a dose.  These things are so obvious in any other area of medicine.  You don't give the same anesthesia to a person who weighs 100 lbs vs. someone who is 200 lbs.   Actually, these things are obvious to a hair stylist.  Could you imagine a study where 600 grey-haired men got the same amount of hair dye - regardless of how much hair they had or how big their heads were?  And then, a bunch of scientists being shocked why some people's scalp burned and others were left with grey hair?  That's how the results are sounding from this study (based on the board posts)...with people pondering why.  Well, gee I wonder what the missing variable(s) could be.

[Luciano]

Well, gee I wonder what the missing variable(s) could be.

Without having been in the study, I suppose one of the obvious variables would be the injection skill (method) of the doctor

[MikeSmith0]

Well, gee I wonder what the missing variable(s) could be.

Without having been in the study, I suppose one of the obvious variables would be the injection skill (method) of the doctor

Yeah that is probably an issue but unfortunately even the top docs had patients with bad side effects.  It could have been a slightly misplaced injection - even from a top doc.  I think the margin for error is very small - and also I forgot to mention another thing I was thinking about.  A flaccid penis shrinks from cold or from anxiety & other factors - so after the injection, the penis needs to be held in a way so that the contraction doesn't cause the collagenase to affect more tissue than it should because the enzyme was injected into a stretched penis which just shrank down after the injection.

The main reasons I am talking about these issues is that I anticipate having this treatment at some point, but the side effects that are public knowledge (told to all study participants) and/or posted here - are pretty scary. There should really be a way to minimize the side effects...even if they are only less than 5% or whatever.  The fact that 1 (or 2?) men had penile fractures makes me think it is reasonable to ask them to do a thorough investigation into why it happened and publish that information as well.

[UK]

The fact that 1 (or 2?) men had penile fractures makes me think it is reasonable to ask them to do a thorough investigation into why it happened and publish that information as well.

Where did you read about the fractures , yes I know its listed as a potential side effect, but has it actually happened?

[Worried Guy]

I remember hearing about that.  Very few though.

[MikeSmith0]

I thought there was an updated consent form they made us sign that told us about it.... but I just looked and it only says  says "of 1082 subjects who received study drug in the Duputreyn's contracture clinical trials, 3 subjects had flexor tendon rupture"  

I cant find the penile fracture part... though it says it is a risk in 3 different places on the form.  I think the study coordinator said there was a fracture verbally.  But that's surprising bc i think everything has to be in writing. I'm not sure now...or if I am not looking at the latest form.  I re-signed the consent forms about 3 times due to updates.  

[BSSS]

Sounds worthwhile to me BSSS.

15 degrees, or a reduction of a third, is very good surely?

I'd say it was nice to have improvement, that's for sure, but some receiving placebo in previous trials had a 15 degree improvement due to swiss cheese effect. But I, like most, endured much for that and some didn't get any improvement at all.

Had my last visit last week, no change reported. Still won't find out if I received drug or placebo yet, but office seemd to indicate there could be one more trial segment. Have no idea how accurate that is.

[LWillisjr]

I think I posted this before but will again. I know many are looking forward to Xiaflex in the hopes that this is the holy grail for those who suffer from Peyronies. I had a follow up appointment with Dr. Levine a few months ago. And I asked him if he had any insight into the result of the Xiaflex study. He indicated that Xiaflex would be another form of treatment, but that it was not the answer for everyone. Like other treatments, it works for some and not for others. Levine indicated that of the study about 30% of the men who did respond to treatments responded favorably. But that the other 70% didn't see any change at all.

It will be interesting see the actual study results.

[fubar]

Makes you wonder if it is the swiss cheese affect ,more than the medicine?

[Woodman]

How Levine explained it 30% working and 70% not working sounds worse then the percentages they pitched to me when I had the VIs. I believe Dr Lipshultzs pitch the VIs for 40% working and 60% not working. I know all the percentages are just talk and a perception of the individuals opinion in the end. I have to admit though its the only thing I have to look forward to that might help once this avenue is exhausted I pretty much have ran out of all options. There really isn't many options to begin with at all. I think they can tell us all the projections and percentages but in the end we will just have to see how many of us here it really helps just like we all learned over time with the VIs. I really hope and wish the very best for it because I don't see others putting this much time or resources in to a treatment for Peyronies Disease in the near future. If it is a success and it makes good revenue it will make other interested in developing treatments for us too. That would be wonderful and can only wish it to be come a reality.

[saramon]

Final followup visit completed, only bloods and urine this time (finally no injections).

Will be advised if I had drug or placebo in the near future, if I received placebo then I can have another course of injections with drug. (but a with a 22° improvement I am fairly certain I had the drug) and doctor reports that he cant detect any plaque (which will mean that there is no injection site ?).

Will post further information as received.

Thanks
S

[james1947]

saramon
Thanks for the update.
James

[bummedout]

Saramon, what do you mean when you say that there is no injection site?

[MikeSmith0]

Will be advised if I had drug or placebo in the near future, if I received placebo then I can have another course of injections with drug.

Saramon, did you have any size changes?

If you had swelling and/or bruising (or similar), you had the drug most likely.  It is virtually impossible to have a xiaflex injection without any reaction. Swelling and bruising occurs in 73% (in the hand...the penis is probably more susceptible).  Negative reactions occur in 98% of cases https://www.xiaflex.com/docs/pi_medguide_combo.pdf - page 7.  

It seemed a little suspect when nurses and doctors say "some people have reactions and some don't" -  in almost identical ways to me when I questioned them about the lack of any swelling...and they avoided my follow up questions with subject changes or shrugs because they only had one line rehearsed.  They are not formally told who is getting the placebo, but I think they know - based on the reactions (which is one other reason the double blind is sort of stupid, because the doctors know who is getting the drug based on the reaction). Collagenase is highly toxic usually just found in gangrene...you'll get a reaction if it is injected in your penis, hand, or probably even left on your skin too long.

Fubar - with the tiny needle and brief injection technique, the placebo does nothing.  There is no real "swiss cheese effect" because there is no real swiss cheese approach.  The needle just goes in, releases a tiny amount of saline & comes out  (making the placebo group that I wasted a year of my life in even more absurd and unnecessary).  If anyone had an improvement from the placebo, it was a coincidence...due to natural resolution of the disease, I would suspect.  And this is already known from other research - and again, there was no reason to waste people's lives in the placebo group (comment made for those reading from Auxilium - unless this design was forced by the FDA).  Lab rats don't have busy and complex lives...people do.  Going through nearly 20 visits to a urologist for penile injections during working hours for some tiny sum of money was quite frustrating to say the least, particularly since no placebo group is truly necessary here.  There are also other statistical methods to analyze the data to determine how xiaflex is working - against itself - instead of vs. a placebo (e.g., hierarchical regression).  Whatever, they don't care.

[james1947]

MikeSmith0 I agree with you 100%. We are not lab rats and your observation that in this case the placebo group was unnecessary is right.
James

[ohjb1]

I have to disagree with the statement that virtually anyone who gets Xiaflex has a significant reaction.  The first injection of Xiaflex I received resulted in only the mildest reaction. No swelling,  no pain and only minimal bruising.  

[loyalty]

I was also in the Open Label Trial and received 4 cycles (8 Xiaflex injections), and had no bruising, pain or swelling after 5 of the injections.  The 3 in which I had bruising, I believe were due to me not holding pressure on the injection site for long enough, as each time I held pressure up until the first blood pressure check (at 15 minutes), there was no bruising.  

[Woodman]

For the guys who have gone through the Xiaflex trials and experienced there plaque(s) disappear to both there eye and touch, has any one had a ultrasound to check and see how the plaque locations show up on the ultrasound results. For instance is the plaque completely gone, is it still there but the scar just changed characteristics, or has it became so small and or thin it doen't effect the deminsions anymore etc.  

[MikeSmith0]

I have to disagree with the statement that virtually anyone who gets Xiaflex has a significant reaction.  The first injection of Xiaflex I received resulted in only the mildest reaction. No swelling,  no pain and only minimal bruising.  

My post was based on the xiaflex prescribing information on the website published by the manufacturer..stating 73% have a swelling or bruising reaction from injection into the finger.  98% have "some" negative reaction (see the link).  Does the penis have less susceptibility to swelling for some reason that would make you think this will be lower than the Duputreyn's group?  I am not a urologist - so I don't know.  And, I had VIs - so I had some serious penile swelling and bruising  (which did dissipate faster than other bruising or swelling elsewhere on the body, interestingly)

The numbers in the PDF are from a trial of thousands of injections.  Your experience vary based on a number of factors like most drugs... but I also think that there are some misunderstandings how this particular drug is precisely supposed to be injected, based on the negative reactions that people have had & some have posted about.  

[MikeSmith0]

I was also in the Open Label Trial and received 4 cycles (8 Xiaflex injections), and had no bruising, pain or swelling after 5 of the injections.  The 3 in which I had bruising, I believe were due to me not holding pressure on the injection site for long enough, as each time I held pressure up until the first blood pressure check (at 15 minutes), there was no bruising.

Somehow, less than 24 hours after I made a negative post about xiaflex side effects - someone who never posted here before about anything - despite being in the open label trial - just happened to come across my thread and was so motivated by it that he had to create a new account respond to it.  What are the odds?  Pretty low, I'd imagine.  

They get even lower that you claim that you only had bruising and swelling because it was your own fault.  Just too perfect... I am sure the manufacturers of Vioxx wished they could have pawned all the fault onto the patients too.  

[MikeSmith0]

MikeSmith0 I agree with you 100%. We are not lab rats and your observation that in this case the placebo group was unnecessary is right.
James

Thanks James.  I appreciate it.

[james1947]

loyalty
Thanks for joining the forum. Your experience is interesting.
Could you give us some more details regarding the procedure in the Open Label Trial?
Could you give us some details regarding your Peyronie's before and after the Xiaflex trial and the time table for improvement if any?
James

[ohjb1]

Response to Mike Smith - I was responding to a statment that essentially stated that any injection of Xiaflex would most likely cause a significant reaction.  My first injection resulted in only a very mild action.  

I was not saying that Xiaflex is w/o risk.  In fact, in my case, my 2nd injection caused such a dramatic adverse event that I had to drop out of the trial.  

[MikeSmith0]

Response to Mike Smith - I was responding to a statment that essentially stated that any injection of Xiaflex would most likely cause a significant reaction.  My first injection resulted in only a very mild action.  

I was not saying that Xiaflex is w/o risk.  In fact, in my case, my 2nd injection caused such a dramatic adverse event that I had to drop out of the trial.

Oh yeah I thought your username looked familiar.  I think I remember reading you dropped out - or it might have been someone else.  I think a few other people in the trial had to drop out due to adverse reactions.  There have also been a handful of posts by unhappy participants like "thiswontwork" and others.  Are you doing better now?

[james1947]

Just my opinion.
What for someone is significant reaction may be to someone else mild reaction. It is more personal feeling.
I read everything on the forum and loyalty is the only one that had no any reaction. He was on the Open Label Trial so he get the medicine for sure.
Loyalty
I hope you are reading the topic and will jump in to give us some more details regarding your own experience.
James

[loyalty]

My experience with the Open Label Trial is this -
I barely made it into the study with a 30 degree curve (as that was the minimum cut off).  I recently had my final follow-up visit, and had a measurement of 18 degrees, for a 12 degree improvement (after 4 cycles).  I followed all instructions, such as modelling, exactly as directed, so I was surprised that I didn't get more of an improvement (Auxillium is hoping for an overall average improvement of greater than 50% - so I would be one who will not help their stats).

Regarding Mike Smith's comments about my first post.  I did not just create a new account. In fact, Mike, I sent you a PM about my Xiaflex experience on 07/29/2011, and sent a PM to another member around that time.  I would have posted and sent more PM's but I was not able to get the character recognition feature to work from August until just the other day.  Regarding my statement about the bruising.  The Urologist and Nurse each instructed me to hold pressure on the injection site for "a few minutes", and I developed a significant bruise after that first shot.  The next day I held pressure for the full 15 minutes up until the first blood pressure check (I decided to try this on my own), and found that I didn't bruise.  I followed this strategy of prolonged pressure on the injection site for each subsequent shot but still had two that bruised.    

[james1947]

Loyalty
Thank you for the answer and clarification. It makes things more understandable. As I say, "significant bruise" can be different for everyone.
You have to understand that people on this forum are very sensitive to posts and some, doing a big work to keep out spams and promotions of medications and med. manufacturers.
Regarding your improvement, you have now 18 degree, it sounds good to me. I am ready to sign with two hands for any treatment to get down to 18 degree.
How about other improvements like length and girth?
James

[UK]

It's still a 40% improvement, not fantastic but not bad either. I'd be interested to know if there were any other improvements too.
I fully expect Auxilium will know whether some doctors performed better than others (obviously each Peyronies Disease case is different) but I am of the opinion in the hands of another doctor and his technique its possible this patient may have had a greater improvement over 4 cycles and same dose.

[MikeSmith0]

That's fine - sometimes certain things on message boards just seem suspicious to me.  I wouldn't take it personally...it's just my own view of what I see on message boards, broadly...based on some past experiences.  I doubt that any employee there could ever post here...or that person would be in serious trouble.  Then again, what has happened with other drugs (neurontin, avandia, phen-fen, rimonabant, vioxx, etc...) makes me wonder.  But anyway, I assume it'll be approved & people will be running to their urologists for it.  There is no other promising treatment - even if this only provides a % improvement, it's better than verapamil or traction... and would probably work better with traction in between cycles (which wasnt allowed in the study... "modeling" isn't that effective in my opinion...since it takes about 5 minutes)

[james1947]

If the new forum members will read the "Off Topic Discussion Area" from the first post (August 26, 2005) forward will understand how difficult and hard work was and it is to keep this forum free of negative things.
I am new member but from reading those posts I understand the sensitivity of the forum members and it makes me sensitive also.
James

[loyalty]

In response to questions about other changes after the Xiaflex injections -
I believe length measurements were taken, as the goniometer (the device used to measure the angle) was made of stainless steel and had ruler type markings on the arms, but I was not told what the length measurements (if any) were. I did not measure myself before or after, although it does seem there was a minor increase in length.  I had no loss in girth with the Peyronies Disease and therefore no increase in girth with the Xiaflex was to be expected.

The most noticeable effect is that now I can just barely feel the plaque, which according to the pre-Xiaflex Ultrasound was something like 1.3 x 0.5 x 0.3 cm. If I didn't know exactly where the plaque was, I would have a hard time finding it now (the Urologist also said he had a hard time finding it at the last visit).  After dealing with this for 10 years, I knew exactly where it was and what it felt like, and now it just feels like a slight thickening of the part of the septum where I used have what felt like a piece of matchstick.

I would have liked to use traction during the trial, but I did not as it was prohibited.  I have since started traction, and hope that it will have some beneficial effect, even though it likely would have been more beneficial during the treatment.

[james1947]

Loyalty
Thanks for the update. Again, your results are encouraging.
Be carefull with the traction device not to make some damage. Moderate usage is the best for Peyronie's.
James

[saramon]

Hi Bummedout

Saramon, what do you mean when you say that there is no injection site?

Doctor told me that Xiaflex needs to be injected into the plaque to dissolve it, therefore with no identifiable plaque then there is nowhere to inject.

Probably means that I received the real thing (no placebo).

Regards
S

[saramon]

Will be advised if I had drug or placebo in the near future, if I received placebo then I can have another course of injections with drug.

Saramon, did you have any size changes?

If you had swelling and/or bruising (or similar), you had the drug most likely.  It is virtually impossible to have a xiaflex injection without any reaction. Swelling and bruising occurs in 73% (in the hand...the penis is probably more susceptible).  Negative reactions occur in 98% of cases https://www.xiaflex.com/docs/pi_medguide_combo.pdf - page 7.  

It seemed a little suspect when nurses and doctors say "some people have reactions and some don't" -  in almost identical ways to me when I questioned them about the lack of any swelling...and they avoided my follow up questions with subject changes or shrugs because they only had one line rehearsed.  They are not formally told who is getting the placebo, but I think they know - based on the reactions (which is one other reason the double blind is sort of stupid, because the doctors know who is getting the drug based on the reaction). Collagenase is highly toxic usually just found in gangrene...you'll get a reaction if it is injected in your penis, hand, or probably even left on your skin too long.

Hi Mike - I had a massive reaction from the first injection of the 2nd round, (looked like the elephant man and probably similar colour). Injections were continued. No change in length but width appeared to be better, though could have been due to the reduction in curvature)

I'm fairly certain that I received the drug, especially as the plaque disappeared.

Thanks
S  

[agent0]

saramon with the injections did u have any changes in feeling or sensation with the plaque gone?

[saramon]

saramon with the injections did u have any changes in feeling or sensation with the plaque gone?

Hi Agent0

No changes in feeling or sensation.  

[BSSS]

I would disagree that there is no swiss cheese effect.

I think the research points to up to a 15 degree improvement in some who only received placebo. If that is the case, what causes imporvement? Imagination? Saline? The point of injecting is to get the needle/solution into the plaque, not in the general area.

With my latest developments, I may be one of those cases....not sure yet. But I def noticed some regression this week upon taking a levitra and getting a good erection. The curve looked much more than 30* and looked to be more back towards 45* which was my starting point.

I'll be glad to hear the results whenever we are 'unblinded.'

[Humorous3]

To All,

Here is a link to a breaking story this morning - Auxilium Soars on Solid Trial Results.

http://www.gaininggreen.com/auxilium-soars-on-solid-trial-results-auxl-aria-fm-conn/121021/

Additionally, there is a new topic on the boards. Rather than spell out all the "higher" boards to direct you there, just use this link to get there:

https://www.peyroniesforum.net/index.php/topic,2500.0.html

Humorous

[jw1441]

from Auxilium websit - investor relations, supporting materials from webcast

potential Xiaflex release for use for Peyronies 3rd or 4th quarter 2013

[ThisWontWork]

from Auxilium websit - investor relations, supporting materials from webcast

potential Xiaflex release for use for Peyronies 3rd or 4th quarter 2013

Dreams ....

[ohjb1]

Recently, there was an article in the Journal of Urology which was mentioned on this forum. The article was published in May/June 2012, but discussed results of Phase II of the Xiaflex study which ended approximately 2 years ago.  Doesn't this seem somewhat odd or am I the only one suspicious about the timing?