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newguy

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UK Xiaflex Trials
« on: January 31, 2011, 11:38:36 AM »

I did post this in another thread, but thought that it's deserving of one of its own. In accordance with the information on the peyronie's uk blog --> Xiaflex Trails are taking place in the UK in February.  I emailed today to double check that places are still available, and I didn't get a 'no' so hopefully they still are. Froma  personal perspective, I'm not going to go for this treatment, because I'm getting on well with other treatments available here, and I have a thing about injections. I know interest has been expressed in Xiafles though, so I'm sure it's appealing to some.
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newguy

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Re: UK Xiaflex Trials
« Reply #1 on: January 31, 2011, 11:44:37 AM »

Actually, I may as well post it here...

Quote
To whom it may concern,


A patient of ours has suggested emailing you some information regarding a new clinical trial for Peyronies disease.


This is a European Trial using Collagenase which will be due to start in Febuary once screening has taken place.


The main inclusion criterias include:


Men with Peyronie's Disease of at least 12 months and with a curvature between 30-90 degrees.


There are a number of other criterias that are stipulated for the trial but these will be discussed with the patients in more detail should they be interested in applying for the trial. The trial is "time intensive" with a number of visits to the clinic set over a 9 month period.


We would be grateful if you know any patients or of any followers of your forums that may be interested in participating in this trial. The patients may ring our office in Harley street on 0207 486 3805 or email myself, at [email protected] for further information.


Many thanks


Yours sincerely


Mandi Kayes

Lead Clinical Nurse Practitioner to Mr David J Ralph
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UK

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Re: UK Xiaflex Trials
« Reply #2 on: January 31, 2011, 03:59:14 PM »

I did read somewhere that in the UK the Xiaflex trial would be an Open Label study ie the participant will know what drug is being administered, not sure if that means there will ne no placebo.
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newguy

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Re: UK Xiaflex Trials
« Reply #3 on: January 31, 2011, 10:11:26 PM »

I did read somewhere that in the UK the Xiaflex trial would be an Open Label study ie the participant will know what drug is being administered, not sure if that means there will ne no placebo.

I didn't know that! Hopefully it's true. If so, that's reassuring for those taking part.
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UK

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Re: UK Xiaflex Trials
« Reply #4 on: February 01, 2011, 03:17:54 AM »

I did read somewhere that in the UK the Xiaflex trial would be an Open Label study ie the participant will know what drug is being administered, not sure if that means there will ne no placebo.

I didn't know that! Hopefully it's true. If so, that's reassuring for those taking part.

I found what I was referring to - reading this indicates any trial outside the US will be Open Label studies

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. 
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George999

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Re: UK Xiaflex Trials
« Reply #5 on: February 01, 2011, 11:41:40 AM »

Oh oh!  They are STILL going to be giving some participants PLACEBO.  I guess they have to do it, but it is too bad some guys are going to miss out on ANY treatment for some time while this thing churns along.  I guess the take home is that if you have something that is working now, think twice before enrolling in this trial.  On the other hand, if NOTHING is working for you, this may be your opportunity.  BUT, REMEMBER, ALL other treatments stop when you enroll in one of these trials!  - George
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ronners

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Re: UK Xiaflex Trials
« Reply #6 on: February 01, 2011, 01:35:10 PM »

Actually George I think you're incorrect -

http://clinicaltrials.gov/ct2/results?cond=%22Peyronie%27s+Disease%22

A placebo is not necessary in an open label trial - there's a number of different trials going on here and they're not all structured the same.
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newguy

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Re: UK Xiaflex Trials
« Reply #7 on: February 01, 2011, 02:35:51 PM »

I've emailed them directly about this issue. Hopefully they'll get back to me soon :).
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newguy

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Re: UK Xiaflex Trials
« Reply #8 on: February 01, 2011, 06:50:36 PM »

Mandi emailed through to confirm that everyone will receive the actual drug, so that's great news. There are no placebo drugs in this trial. I'll post a note on the blog too later, so that people know that they will be receiving Xiaflex.  Other info,: those taking part will potenitally be receiving 8 injections (2 injections per cycle - 6 weeks apart).
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George999

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Re: UK Xiaflex Trials
« Reply #9 on: February 01, 2011, 07:29:20 PM »

Newguy,  You are, of course, referring to the UK trials when you say "no placebo", correct?  Because the quoted PR release seems to indicate that US and Aussie trials WILL include placebo.  - George
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newguy

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Re: UK Xiaflex Trials
« Reply #10 on: February 01, 2011, 10:01:35 PM »

Newguy,  You are, of course, referring to the UK trials when you say "no placebo", correct?  Because the quoted PR release seems to indicate that US and Aussie trials WILL include placebo.  - George

Oops, yes. My comment is specific to the UK study.
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shrout

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Re: UK Xiaflex Trials
« Reply #11 on: February 10, 2011, 03:33:45 PM »

Thanks for posting this Newguy. I rang Mandi Kayes today and am now on the waiting list. Hopefully I'll be chosen for the trial. I think I satisfy all the requirements.

Will keep you posted.
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fubar

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Re: UK Xiaflex Trials
« Reply #12 on: February 10, 2011, 09:29:46 PM »

Newguy

This is exciting news a study using the medicine on all patients.Wow wonder if this is something that might expedite its use if it works wonders.Again we have to be patient remember men have been suffering this sense the 1700' s.

Lets hope that our train comes soon especially for the young and those suffering for along time.

Fubar
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newguy

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Re: UK Xiaflex Trials
« Reply #13 on: February 11, 2011, 12:26:04 PM »

Thanks for posting this Newguy. I rang Mandi Kayes today and am now on the waiting list. Hopefully I'll be chosen for the trial. I think I satisfy all the requirements.

Will keep you posted.

I have my fingers crossed for you!!


Lets hope that our train comes soon especially for the young and those suffering for along time.

Fubar

Yes, this is an exciting opportunity for people. The best part being that those accepted to the study, know that they are getting the real thing, and won't have to pay for the treatment. Hopefully some of them will report back here with their thoughts, just as those in the US studies have done.
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ComeBacKid

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Re: UK Xiaflex Trials
« Reply #14 on: March 03, 2011, 02:51:33 AM »

Any updates from UK men in the xiaflex trials?
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ronners

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Re: UK Xiaflex Trials
« Reply #15 on: March 03, 2011, 03:28:13 AM »

The Trials have not yet begun ...
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smithgareth

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Re: UK Xiaflex Trials
« Reply #16 on: April 08, 2011, 03:46:29 PM »

They have now, just had my first injection today. Stung a bit and it's a bit sore now. 2nd injection tomorrow then back again on Monday. Anyone else on the trial?
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Worried Guy

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Re: UK Xiaflex Trials
« Reply #17 on: April 08, 2011, 07:17:02 PM »

So the trials have started. Great news!  I will speak to my uro in 10 weeks and ask him how it is going as he is carrying them out at UCHL.  That is a lot of injections!!!?  How come you are having so many in such a short period.  Don't they allow weeks in the USA between shots?
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waitingforxiaflex

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Re: UK Xiaflex Trials
« Reply #18 on: April 08, 2011, 07:41:47 PM »

Hi,

Another UK trialist signing on...

Wow, I've been waiting for this day for about 8 years which was back when Biospecifics were developing this drug - monitoring its progression somewhat religiously and so I can hardly believe the day has finally come. Being only 37 it's been a rough period of time and my hopes are somewhat high.

Anyway, had the first injection today and as Gareth said, the injection did rather sting. The needle went deeper than what I thought it would, before Amr started to pull it out whilst injecting the solution.

I'm now rather swollen and like previous posters have mentioned, the penis has doubled in girth and starting to turn a mixture of red and dark blue. It is extremely tender although walking is totally fine. I'm not sure how Amr will find the plaque for the second injection tomorrow though with it being this swollen. However, I am sure tomorrow's injection will be much more painful with the penis being so tender now and the swelling and bruising will get a lot more intense. I'm slightly worried I'll be walking like John Wayne after tomorrow.

Incidentally, Cycle 2 sounds like it will be slightly harder too which requires an induced erection to measure any improvement before the 3rd collagenase injection (into the flacid penis still) can me administered. I really find those alprostadil injections painful, not especially the injection itself but the medicine stings for the penis for the rest of the day.

Anyway, I'm really pleased to be on the trail and am hoping that this treatment will end the living nightmare that so many face with this spiteful disorder.

Best of luck to you all.

WFX
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Worried Guy

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Re: UK Xiaflex Trials
« Reply #19 on: April 08, 2011, 07:46:30 PM »

Great news you got on the trail.  I'm praying for good results for everyone and also myself.  I was told that I had just missed out on the trial but if it were a success I would likely get it. So how many injections will you have in total?
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waitingforxiaflex

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Re: UK Xiaflex Trials
« Reply #20 on: April 08, 2011, 07:54:03 PM »

So the trials have started. Great news!  I will speak to my uro in 10 weeks and ask him how it is going as he is carrying them out at UCHL.  That is a lot of injections!!!?  How come you are having so many in such a short period.  Don't they allow weeks in the USA between shots?


Gareth means that Monday is modelling day. Injections are only done on the Friday and following Saturday visits. Treatment cycle 2 (Friday injection, Saturday injection, Monday modelling) starts in 6 weeks time on the 20th May. Cycle 3 starts 6 weeks after that, and the final forth cycle, 6 weeks after the third. This is rounded off by 2 follow up visits some weeks after the final cycle.

A total of 15 visits may be required I think (including the screening visit), but if your curvature drops below 15 degrees the treatment stops but you still have to attend the clinic for one visit each cycle for a check up.

There could be a maximum of 8 collagenase injections over 4 treatment cycles. I hope this explains everything clearly.

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Worried Guy

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Re: UK Xiaflex Trials
« Reply #21 on: April 08, 2011, 08:01:04 PM »

This helps.  Please keep us posted on your progression and I wish you all the best. 
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waitingforxiaflex

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Re: UK Xiaflex Trials
« Reply #22 on: April 08, 2011, 08:10:10 PM »

This helps.  Please keep us posted on your progression and I wish you all the best. 

Thanks. I'll keep posting updates. In the meantime I can recommend getting a penis extender / stretcher if you haven't already got one. This along with the PAV cocktail (pentoxifylline, arginine, viagra (or cialis) seemed to work the best for me up until this opportunity, as suggested by Prof Levine when he was holding a clinic at Mr.Ralphs in Harley St in November 2010. It sounds like you are seeing Mr Ralph at UCLH as opposed to Harley St which is good. I've been having to pay for my prescriptions privately.
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smithgareth

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Re: UK Xiaflex Trials
« Reply #23 on: April 09, 2011, 04:15:07 PM »

Hi,

Another UK trialist signing on...

Wow, I've been waiting for this day for about 8 years which was back when Biospecifics were developing this drug - monitoring its progression somewhat religiously and so I can hardly believe the day has finally come. Being only 37 it's been a rough period of time and my hopes are somewhat high.

Anyway, had the first injection today and as Gareth said, the injection did rather sting. The needle went deeper than what I thought it would, before Amr started to pull it out whilst injecting the solution.

I'm now rather swollen and like previous posters have mentioned, the penis has doubled in girth and starting to turn a mixture of red and dark blue. It is extremely tender although walking is totally fine. I'm not sure how Amr will find the plaque for the second injection tomorrow though with it being this swollen. However, I am sure tomorrow's injection will be much more painful with the penis being so tender now and the swelling and bruising will get a lot more intense. I'm slightly worried I'll be walking like John Wayne after tomorrow.

Incidentally, Cycle 2 sounds like it will be slightly harder too which requires an induced erection to measure any improvement before the 3rd collagenase injection (into the flacid penis still) can me administered. I really find those alprostadil injections painful, not especially the injection itself but the medicine stings for the penis for the rest of the day.

Anyway, I'm really pleased to be on the trail and am hoping that this treatment will end the living nightmare that so many face with this spiteful disorder.

Best of luck to you all.

WFX
Interesting that you got swelling and a mix of red and dark blue from the first injection, I just had a little red welt and a bit of pain overnight. However after the 2nd injection today I'm very swollen and the skin is badly discoloured angry red, black and purple. Just hoping it all calms down before Monday!!
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waitingforxiaflex

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Re: UK Xiaflex Trials
« Reply #24 on: April 10, 2011, 07:10:42 AM »

Well, yesterday was the day for the second injection.

When I woke up yesterday morning (Saturday) the swelling had gone down by about 50% which was a relief, but the penis was still rather tender and bruising had increased to over the whole of the penis.

At the clinic before the second injection took place, Amr said that to him the plaque was harder to detect but thought that this was more due to the medication working as opposed to the swelling. He also said that his impressions were that it was not imperative to hit the plaque directly with the injection as the medication diffuses over the whole penis, as evidenced by the swelling of the whole penis. The staff commented that everybody apart from one person (Gareth I guess!) had significant swelling but the bruising varied quite widely. Apparently, one chap had bruising all around the groin area as well as the penis.

Anyway, the second injection itself didn't hurt anywhere near as much as the first, with only very mild pain like with a blood test. It didn't seem anywhere as deep. I'm not sure whether Amr had adjusted his technique or whether it was due to me knowing what to expect. About 10 minutes after the second injection, the penis started to sting (similar to the pain I feel with alprostadil injections) which lasted for about an hour. This didn't happen after the first xiaflex injection.

Over the next 8 hrs the penis began to swell more and more and became very painful to look a bit like a big blue sausage roll. The swelling was much worse than after the first injection. If I would rank the pain after the first injection as 4, this was 6 or 7 and was a bit of an ordeal to be honest. I had to take some of my back pain medication like diclofenac and co-codamol which helped. Walking was now a bit of a problem and so I decided to stay in last night. Lying in bed wasn't so painful for the penis, but walking around put pressure on where the penis attaches to the body (the penis was quite handful and heavy) which itself was quite bruised and tender now.

This morning (Sunday) the swelling has gone down by 50-60% and I'm not needing any pain medication but there is some tenderness in the pubic area now and a small bit of bruising too. I could probably manage to wander into town later if I wanted to, although the penis is still very tender and bruised.

I expect the swelling to go down tomorrow to for third visit for modelling tomorrow evening.

It's hard to tell whether things are improving (curvature wise) at the moment as the penis is still quite deformed from the swelling and looking for the plaque is rather painful.

That's it for now.

wfx


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Luciano

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Re: UK Xiaflex Trials
« Reply #25 on: April 10, 2011, 12:05:42 PM »

Been reading this with great interest,
thank you guys for going through this (for us others)
One question, you are all talking about "modelling day" after second injection..
For an outsider, what is "modelling" in such a study?
Luc
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waitingforxiaflex

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Re: UK Xiaflex Trials
« Reply #26 on: April 10, 2011, 12:36:44 PM »

Hi Luciano,

As far as I am aware on Monday evening, the investigator running the trial will gently bend the penis in such a way to try to stretch the (hopefully now) thinned down and weakened plaque. I'm expecting to hurt a bit. We then have to repeat the modelling (or stretching) at home, every day until the next cycle. In Auxillium's PhaseIIb trials it was found that patients who were asked to model their plaque got slightly better results from those who did not. Using traction devices like the fastsize / jess extender etc (which a few of us may have been using regularly before this trial) would be too harsh at this stage and so gentle manual stretching is required.

I will post my experiences on Tuesday.


Regards,

wfx
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Luciano

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Re: UK Xiaflex Trials
« Reply #27 on: April 10, 2011, 01:31:23 PM »

Thanks for the explanation. Looking forward in reading your reports.
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waitingforxiaflex

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Re: UK Xiaflex Trials
« Reply #28 on: April 12, 2011, 09:01:42 AM »

So yesterday was the day for the "modelling" which is described as a gentle bending of the penis to stretch the plaque area...

I woke up on Monday morning and the swelling had subsided another 50% (the improvements seem only to happen overnight) which was good I thought as it would be easier to find any plaque that was remaining. The penis was still bruised and pretty painful although that too was slowly easing.

However, I found the modelling itself done by the study doctor to be *extremely* painful. Seriously, I'd rate it an 8/9 out of 10. I was surprised at how much force seemed to be used and was swearing quite loudly. The study doctor said he was trying to break up the plaque - I didn't think we would be using the Dupuytren's protocol here! The protocol said gently stretching I thought. As an aside, it made me think that the success of Xiaflex will have significant dependence on the skill/experience of the urologist and his interpretation of instructions / choice of force and where it's applied. As Peyronies Disease sufferers we all know how fragile our best friend is and that more force may not mean a better result.

This morning the swelling had gone down a bit more but the penis was very sore today, especially where the study doctor had been stretching which i'm not sure was the site of my plaque?!? I managed to get an erection this morning and to be honest, the curve looked worse, with no improvement at the site of the old plaque (near the tip) and a new curve point slightly lower down the shaft where I think the study doctor was stretching. What I thought was my plaque and a distinguishable cord that used to run down the shaft can no longer be found. Instead there seem so be new bumps and indentations and worryingly, also what seems like a new lesion/tear where the study doctor was stretching.

I'm really hoping that I'm just being overly worried or this is just due to swelling and that things settle down and improve over the next 6 weeks. I would be totally devastated if this treatment made things worse as I only had a 30 degree bend in the first place.

Garreth, what did you make of the modelling? Are you seeing any improvement?

So, my thoughts directly after the first cycle are this:
That Xiaflex treatment with modelling is not to be taken lightly and some people will find it very painful. It is a powerful drug but the urologist's choices he makes with the treatment will probably impact your outcome too.

The modelling that we have to do at home is nothing like what the study doctor did. You have to stretch the flaccid penis as far as it will go for 30 seconds, 3 times a day so it's pretty much just mild hand traction and shouldn't cause much pain.





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smithgareth

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Re: UK Xiaflex Trials
« Reply #29 on: April 12, 2011, 06:30:47 PM »

Hi folks,

Well everything did calm down by Monday evening, and then I went for the modelling. Definitely an 8-9/10 but more for skin pain with me, at one stage I thought he was giving me a chinese burn! My plaque is near to the base of my shaft, part buried by a little fat and I suppose it's not easy to stretch a limp penis!! Anyway, walked away really with sore skin which has carried on though today. However when I woke during the night I was shocked, everything definitely seemed straighter and pain free which I wasn't expecting!!  I've not done my stretching tonight, been out pretty much all day and with the skin still very sore I thought I would start tomorrow. Funnily the injection sites were a bit tender and itchy today, hopefully they will calm down by the morning.
I think I've been luckier than some, my 1st injection whilst hurting didn't cause swelling and whilst my 2nd injection wasn't pleasant and the stretching hurt, all in all I've got to give Xiaflex a fair go. We've got 4 treatment cycles and I think that the idea is to break the plaque and then to break the bits of the plaque. So simplistically cycle one splits it into 3 lumps, cycle 2 then targets the biggest remaining 2 lumps and so on and so forth in much the same was as they blast tumours apart. So hopefully if we all stick at it, the drug will obtain it's licence and we'll see further refinement in treatment methods. For those of you who saw the early trials I seem to recall they were doing multiple injections into the plaque which I can only imagine how much that must have hurt!!

Good luck to everyone for cycle two, only 5 weeks and 3 days to go!!
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waitingforxiaflex

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Re: UK Xiaflex Trials
« Reply #30 on: April 13, 2011, 05:59:40 AM »

After yesterdays panic, cautiously more optimistic this morning.

Swelling has gone down a bit more and so has the bruising quite a lot (had a bath last night which definitely helped). A semi-erection this morning actually looked pretty promising, appeared slightly straighter than when I started the trial - the curve softer.

Yesterdays erection which looked more curved could have been due to the swelling distorting it. The skin of the penis is still reasonably painful and there is a swollen lump under the skin which could have been the injection site. The swelling could have also produced a contour which felt like it could be a crevice/tear which I mentioned and was worried about in my previous post. This is still present but less pronounced.

So... fingers crossed.

I pm'Erectile Dysfunction a few people on the trial in other countries who were receiving the real drug and neither of their study doctors were so zealous with the modelling, actively trying to avoid pain in fact, but the they were still getting pleasing results for the cycle.

I think I may pass on the modelling next time  :o


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Worried Guy

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Re: UK Xiaflex Trials
« Reply #31 on: April 13, 2011, 02:00:05 PM »

The Xiaflex trial seems to concentrate on the obvious problem of peyronie's which is curvature! Has anything been said about an improvement of girth and length.  These tend to come hand in hand with plaque.  Are they measuring girth and length on you guys? 
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smithgareth

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Re: UK Xiaflex Trials
« Reply #32 on: April 13, 2011, 04:59:08 PM »

Hi wfx,

A bath definitely helped me, definitely sore around the injection site, but a little less so today.

worriedguy:

They are monitoring length but not girth (or I don't remember any girth checks). I suppose curvature and length are more important than girth.

Just doing my stretches!!
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MikeSmith0

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Re: UK Xiaflex Trials
« Reply #33 on: April 13, 2011, 07:28:32 PM »

Wow thanks for the description guys.  I am also in the study in the USA but had zero reaction to ALL the shots so far, so I am probably getting the placebo.

Do you know why there is no placebo condition in the UK?  I just find that interesting... common sense would tell you there should be no placebo condition here either, but the USA FDA (food and drug administration) doesn't operate by common sense when approving a drug.  Looks like your healthcare system does.

I won't get the real drug until the summer of 2012 so i am gonna be really curious what happens to you... in particular, with size issues bc that has been a problem in addition to the curve.  Please keep us posted on that front.

Isn't the doctor just injecting it directly in the plaque?  How could it spread beyond there?  There is only 0.58 mg... I would be more inclined to think you are just getting a reaction in the whole penis bc the body is creating a major immune / inflammatory response to this substance (which is a foreign protein)  that is calling blood cells to the whole area.  You know?  Bee stings can make a whole hand swell up even though the venom isn't in the whole hand.  The body responds more in some cases than others.  I also wonder, if you took benadryl (diphenhydramine / anti-histamine) if that would lower the inflammation...if it is related to a response to the protein.  

I wouldn't expect any changes in the curve for a few weeks - until things settle down...and it might improve over months after that as it heals and the elastin is restored.    But whatever happens, THANK YOU for posting on here.  This is the first info I read from a xiaflex patient that is 100% confirmed to be a xiaflex patient...not someone who might be in  the placebo group.
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waitingforxiaflex

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Re: UK Xiaflex Trials
« Reply #34 on: April 14, 2011, 06:19:39 AM »

Good news today!

Measured my curve and it has gone from 30 degrees to 20 degrees. I took photos before the first injection and compared them to a photo from this mornings erection. Got them up on the computer screen and measured with a protractor. There is an obvious difference between the two photos - the curve is softer and less pronounced.

I had another bath last night which again helped with the bruising this morning. Only pain today is still at the injection site which is still swollen. I can still feel a small bit of plaque but it's much smaller than before.

Hopefully with the manual stretching I could eek out a few more degrees before the next cycle. I won't post anymore updates until just before the next cycle on the 20th May unless something of particular note happens.



Hi Mike, in clinical trials the group that gets the active drug is always bigger than then placebo arm. It sounds like Auxillium are using the UK and a number of other European countries to boost the numbers in the active drug arm. I think Auxillium can use US placebo data to file in Europe with the EMEA. 

Size is looking good and the penis feels fleshy which is also good. The doctor is aiming for the plaque. In my case I think he missed the main bit by a few mm, but my plaque was difficult to locate because it was still soft. I hope is now that elastin is restored and that the injection site doesn't become another bend in th future.

Finally, sorry to hear that you think you are in the placebo group. I have had Peyronies for over 8 years (since I was 28/29) and so I know the pain. Hopefully there is a light at the end of the tunnel for you with the Summer 2012 date.
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shrout

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Re: UK Xiaflex Trials
« Reply #35 on: April 14, 2011, 09:29:07 AM »

I was hoping to get on the trial, but it's clear from the posts this past week that they've started, and I haven't.. so disappointed, obviously, but pleased for those who are lucky enough to be participating, and that the results look so promising.

Could I ask those who are taking part, how many of you are there on the trial, and whether you have anything in common? Are you all patients of Mr.Ralph, for example? Or do you have a similar curvature, or age, perhaps? I'd be interested to know.

I had three consultations at UCLH last year, but was seen by Mr. Nim Christopher, who didn't seem particularly clued up on Xiaflex, or any impending trials. I'm wondering if this had any bearing on who was chosen.

Anyways, thanks for the detailed posts guys, and best of luck for the remainder of the trial.
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waitingforxiaflex

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Re: UK Xiaflex Trials
« Reply #36 on: April 14, 2011, 10:03:10 AM »

Hi Shrout,

There are 10 people on the trial and the first cycle has just been completed.

The next injections in our treatment cycle start on the 20th May. I was told by the trial co-ordinator (Mandy Kayes) that they hope to recruit another 10 patients or so later in the year to repeat another trial (open label, active drug).

Here are the details of the trial with exclusion and inclusion criteria: http://clinicaltrials.gov/ct2/show/NCT01243411

You may want to make sure you meet these criteria before you get your hopes up.

If you think you meet these criteria then I suggest you contact the study center to express your interest:

St. Peter's Andrology Centre   
London, United Kingdom, W1G 6BJ
Contact: Mandy Kayes     44 (0) 207 486 3805     [email protected]    
Principal Investigator: David Ralph    

I have been a private patient of Mr.Ralph's since around 2004 and Mandy called me in March to see whether I would be interested (although on each occasion I visited Mr.Ralph through the years I have asked about injectable collagenase and expressed interest in any trials). I'm not sure about the other participants, whether they were private patients of Mr.Ralph or their ages, deformities etc but I know that we all meet the inclusion criteria.

Good luck!

BTW: Xiaflex (as Xiapex) has just been launched in the UK for Dupuytrens, the first country in the EU.
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MikeSmith0

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Re: UK Xiaflex Trials
« Reply #37 on: April 15, 2011, 12:08:08 AM »

Good news today!

Measured my curve and it has gone from 30 degrees to 20 degrees.

That's impressive with 1 round of shots... congrats.
 
Did you have any narrowing over all these years?  (if  so - any change?)  How stable was your situation?  I feel like I'm getting worse but hard to say.
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newguy

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Re: UK Xiaflex Trials
« Reply #38 on: April 15, 2011, 12:40:23 AM »

I was hoping to get on the trial, but it's clear from the posts this past week that they've started, and I haven't.. so disappointed, obviously, but pleased for those who are lucky enough to be participating, and that the results look so promising.

I echo the opinion of others that you should continue to express your interest. A recent email regarding the study is up at the peyronie's disease blog and suggests that they may recruit further subjects in the future:

Quote
We are up to our full quota of recruits for the study now and I would like to say a big thank you to you and your website as we had an excellent response from potential people. Unfortunately, due to the strict exclusion criteria and the amount of subjects we can recruit there were a few people we haven't been able to include.

We may at a later stage be allowed to recruit more subjects, depending on how the other Uk sites have managed. I will let you know if this should happen!

Best wishes and again many thanks for your help with putting the word out there!
- Peyronie's Disease Blog

It's great news that there appears to be some positive results already from those in the trial. It offers yet another avenue of improvement for peyronie's sufferers.
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shrout

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Re: UK Xiaflex Trials
« Reply #39 on: April 15, 2011, 04:57:26 AM »

wfx, very useful information. Many thanks...

I hadn't realised the numbers were so restricted. There are bound to be a lot of disappointed guys like me out there.

I don't actually meet criterion no.2 (stable relationship with partner/spouse for 3 months prior to the trial etc.). That's not something which can easily be manufactured.  ( I would of course be willing to attempt vaginal intercourse before, during and after the trial, should a suitable lady be provided :-). But I don't suppose that's part of the deal. )

Newguy, thanks again for the encouragement. I will continue to register my interest with Mandy Kayes despite the drawback. And as you say, great news. The drug is finally here and it appears to be working. Fingers crossed for the next phase of the trial, and hopefully we'll see xiaflex widely available (and affordable!) as a treatment for Peyronies in the not too distant future.
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tunnelman

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Re: UK Xiaflex Trials
« Reply #40 on: April 15, 2011, 06:21:24 AM »

Hi Guys

This is a first time post for me on here. I'm a |UK resident.

Thanks for all the info......

I've recently been diagnosed with Peyronies Disease. I've had pain for a while now and noticed my curvature (to the left) about two months ago. I've seen a local urologist (well actually I didn't get to see the local specialist in Peyronies Disease, although my appointment was with him, I saw one of his colleagues who was very matter of fact) since then I've found this forum. After this post I'm writing to my local specialist, he ain't getting away that easy :) and in fairness he has rang me since I rang to question why I didn't see him but I missed the call.

Anyway thats my rant out the way. I've an appointment with Mr Ralph in just over two weeks time as a new patient so it will be interesting to see what he has to say re this. His secratary did indicate that a trial was happening so it is interesting to actually read posts from trial volunteers.

I will share any info that I recieve.

I was about to stock up on Pentox but might hold fire until I've seen him. Does anyone know if Mr Ralph prescibes Pentox?

Any contacts from the UK would be most appreciated.

Thanks

Tunnelman
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UK

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Re: UK Xiaflex Trials
« Reply #41 on: April 15, 2011, 07:27:45 AM »

Hi Guys

This is a first time post for me on here. I'm a |UK resident.

Thanks for all the info......

I've recently been diagnosed with Peyronies Disease. I've had pain for a while now and noticed my curvature (to the left) about two months ago. I've seen a local urologist (well actually I didn't get to see the local specialist in Peyronies Disease, although my appointment was with him, I saw one of his colleagues who was very matter of fact) since then I've found this forum. After this post I'm writing to my local specialist, he ain't getting away that easy :) and in fairness he has rang me since I rang to question why I didn't see him but I missed the call.

Anyway thats my rant out the way. I've an appointment with Mr Ralph in just over two weeks time as a new patient so it will be interesting to see what he has to say re this. His secratary did indicate that a trial was happening so it is interesting to actually read posts from trial volunteers.

I will share any info that I recieve.

I was about to stock up on Pentox but might hold fire until I've seen him. Does anyone know if Mr Ralph prescibes Pentox?

Any contacts from the UK would be most appreciated.

Thanks

Tunnelman

Ralph prescribed me Pentox on a private appointment. I asked for it, he obliged. Did not use it himself but was aware if was being used in San Francisco - that was about it.
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waitingforxiaflex

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Re: UK Xiaflex Trials
« Reply #42 on: April 15, 2011, 01:26:56 PM »

Hi Tunnelman,

Think about supplementing the pentox with arginine and viagra/cialis - the PAV cocktail if you can.

Arginine can be obtained from Holland and Barrett and cialis/viagra either online or from pharmacies.

All 3 of these components increase blood flow to the penis and inhibit fibrosis and the literature suggests they have the biggest impact in the acute stage, so go for it!

This is what the main US Peyronie's urologists (Levine etc) prescribe.

BTW, you will probably have to order pentox in advance from the pharmacy so that they can order it in. No pharmacies I know stock it outright.

It's trade name is TRENTAL and comes in 400mg extended release tablets and costs around £23.50 on a private pescription for a months dose.

The current trials center around the use of Xiaflex for chronic, stable Peyronies. By the time it is on the UK market assuming EMEA success (about 2-3 years) you should be stable but you may not need it after all if you are lucky with the oral meds.

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crashbandit

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Re: UK Xiaflex Trials
« Reply #43 on: April 15, 2011, 11:22:17 PM »

Hi Tunnelman,

Think about supplementing the pentox with arginine and viagra/cialis - the PAV cocktail if you can.

Arginine can be obtained from Holland and Barrett and cialis/viagra either online or from pharmacies.

All 3 of these components increase blood flow to the penis and inhibit fibrosis and the literature suggests they have the biggest impact in the acute stage, so go for it!


I wouldn't want to take Arginine with Cialis. Arginine is a Precursor for the synthesis of nitric oxide (NO), which Cialis warnings clearly state don't take Nitric oxides. This is a bad, possible lethal, combination. I've stopped taking my ALC for this very reason, since I'm on a low-dose cialis now.
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fubar

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Re: UK Xiaflex Trials
« Reply #44 on: April 16, 2011, 01:20:58 AM »

Crash

Great observation, now you might be saving lives.Me being a heart patient learned that early have not taken my nitro sense onset of this disease or the other.

Fubar: this can bee a risky business! 
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Luciano

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Re: UK Xiaflex Trials
« Reply #45 on: April 16, 2011, 03:21:48 AM »

Sorry if i'm getting off topic, but i am starting to get worried:
I wouldn't want to take Arginine with Cialis. Arginine is a Precursor for the synthesis of nitric oxide (NO), which Cialis warnings clearly state don't take Nitric oxides. This is a bad, possible lethal, combination. I've stopped taking my ALC for this very reason, since I'm on a low-dose cialis now.

Hmmmm .. I have been just taking L-arginine and Cialis for a week now... (cialis for a month)

I will stop the Arginine as long as I am taking cialis

May I just ask a stupid question:
Cialis is an PDE-5 Inhibitor just like Viagra.

In the PAV coctail promoted by Levine we have Pentox - Arginine and Viagra
Does it apply to Viagra also?

Somewhere I read they tested with cialis because it was easier to administrate and remained longer in the body (so it was actually a pricing question)

Without wanting to hijack this thread..
Another question: Are we talking about Arginine (You said you stopped taking ALC - in my mind that was Acetyl-L-Carnintine)
Does it apply to ALC also or only to L-Arginine?

Luc *confused and worried*

--------
Taking actually:
3x 400mg pentox (since 3 months)
2x 1000mg ALC (since 1 week)
2x 1000mg L-arginine (since 1 week)
3x 100mg ubiquinol (since 3 months)
3x 3 neprinol (since 1 month)
1x 5 mg cialis (since 1 month)
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waitingforxiaflex

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Re: UK Xiaflex Trials
« Reply #46 on: April 16, 2011, 11:57:02 AM »

Hi Tunnelman,

Think about supplementing the pentox with arginine and viagra/cialis - the PAV cocktail if you can.

Arginine can be obtained from Holland and Barrett and cialis/viagra either online or from pharmacies.

All 3 of these components increase blood flow to the penis and inhibit fibrosis and the literature suggests they have the biggest impact in the acute stage, so go for it!




I wouldn't want to take Arginine with Cialis. Arginine is a Precursor for the synthesis of nitric oxide (NO), which Cialis warnings clearly state don't take Nitric oxides. This is a bad, possible lethal, combination. I've stopped taking my ALC for this very reason, since I'm on a low-dose cialis now.


Crash,

That's exactly what I said to Levine when he prescribed it to me but he said it wouldn't be a problem and I don't find it to be.

However you raise a good point that people should consider their medical backgrounds and history before they take internet advice, and should really talk to a doctor.


Thankyou  :)


PS: Luciano - Levine said I could take Cialis instead of Viagra if I wanted to (which I do for the reasons of it being longer lasting)
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crashbandit

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Re: UK Xiaflex Trials
« Reply #47 on: April 16, 2011, 01:58:15 PM »

Sorry, my mistake about the ALC. I got it mixed up with GPLC (Glycine Propionyl-L-Caritine), which is a definite NO increaser. I did alittle research on ALC and I can't see it being listed as increasing NO production.

I'm not sure about Viagra and Nitric Oxide supplements.
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tunnelman

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Re: UK Xiaflex Trials
« Reply #48 on: April 16, 2011, 08:13:19 PM »

Thanks for the info gents. I've started on everything bar the Pentox and Cialis. I will see Ralph in a two weeks time and alos order over the net. Any heads up on best suppliers to the UK?

Thanks
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Worried Guy

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Re: UK Xiaflex Trials
« Reply #49 on: April 17, 2011, 05:38:09 PM »

http://www.oncologytube.com/index.php?page=videos&section=view&vid_id=100494

Now I know a few of you have seen this video before but it highlights a few of my concerns with Xiaflex which have not been addressed.  He talks about what happens when the scar is dissolved. 

It seems like they are not measuring girth on the study but it sounds like they should be.  Nobody wants a thinner penis than when they started especially when some of us have a thinner penis due to peyronie's anyway.
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