Xiaflex

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newguy

Look everybody, Xiaflex has its own thread :). Time will tell if it actually deserves it. I found this today. It relates to use in DC, but presses the point that it's VERY important once/if this stuff is eventually available to us all, to get the right guy injecting it..

QuoteAuxilium's (NASDAQ:AUXL) Xiaflex FDA Advisory Panel will likely be focused on a surgeon education and training program that will be in place to limit side effects from improper use, such as tendon rupture and digital nerve damage, hand surgeons told Pharmawire.

The FDA's Arthritis Advisory Committee will tentatively review Xiaflex on 16 September 2009. The FDA advisory committee is looking at including hand and/or orthopedic surgeons on the panel, but the breakdown has not been revealed, according to Will Sargent, vice president of investor relations and corporate communications at Auxilium.

Regardless of the FDA pathway, Auxilium believes that educating the surgeon base about the proper technique for injecting Xiaflex is important, Sargent said. The company is planning a "robust" education program that it plans to share with the FDA, and is in a dialogue now, he said. The education program would ensure that surgeons are aware of the risk/benefit profile and are aware of what worked best in clinical testing, he added.

Dr Srinath Kamineni, a consultant orthopedic surgeon and elbow, shoulder, hand and wrist specialist in London, said that extensive training is needed - citing the potential risks of tendon rupture and nerve damage with injections. Tendon rupture is a huge concern because if Xiaflex is injected in the wrong place, it could lead to tendon breakdown, he said.

In the CORD I and II studies, the open-label JOINT I and II studies and the pharmacokinetics study, there were a total of three confirmed tendon ruptures (rate per injection = 0.14%); one reported tendon rupture remains unconfirmed (rate per injection = 0.05%).

The rate of tendon rupture is probably acceptable, according to Dr Roy Kulick, associate professor of orthopedic surgery at Albert Einstein School of Medicine and director of orthopedic hand surgery at Montefiore Medical Center in New York. If the cord is on top of a tendon, ruptures could occur if the injections are deep but they do not happen often, he said.

Tendon rupture is a major concern, said Dr Robert Szabo, professor of orthopedic and plastic surgery at the UC Davis School of Medicine. The clinical trials have been performed by surgeons who are more familiar with the disease so the results are better than they will be once Xiaflex is available to the public. The concern is that Xiaflex will have to be limited to surgeons, he said. If it is marketed to everyone, there will be a lot of problems, he added.

It is really a question of training, said Dr Larry Hurst, chief of hand surgery and chair of the department of orthopedics of the Health Science Center at the State University of New York at Stony Brook, and primary investigator of the CORD trials, noting that certain trials in Australia were done by rheumatologists.

The rate of tendon rupture was reasonable, said Dr Roy Meals, a clinical professor of orthopedic surgery at the University of California, Los Angeles, and an investigator for Xiaflex. Tendon rupture is partly technique dependent, he said. Education will probably start in hand surgery, where surgeons will be taught the potential risks and benefits of Xiaflex so they can use it safely, he said.

Xiaflex should be approved but with some reservation about widespread use, noted Dr William Townley, a plastic surgeon at Salsbury District Hospital in the UK. The agent will probably have the best safety if given by qualified hand/plastic surgeons with the appropriate anatomical knowledge, experience and ability to deal with complications, as well as awareness of surgical alternatives, he said.

The technique should be relatively easy to pick up, but the company will need to tell doctors to learn it well or else might Xiaflex may cause tendon rupture, said Dr F. Thomas Kaplan, a surgeon at the Indiana Hand Center.

Meals said many physicians hope that Auxilium will restrict the distribution of Xiaflex to prevent rheumatologists and dermatologists from using it because there would probably be more tendon ruptures if they did. These specialties have not seen the cord of tissue that causes the contracture and do not have a good spatial understanding of the hand, he said. "It is a scary thought," he added.

However, the severity of the rupture depends on which tendon is affected since some patients would not even know that a tendon ruptured if it did not disrupt motion, Meals said, noting that these patients already have limited motion from the contracture and that if Xiaflex brings the contracture towards normal a tendon rupture is much less of a consequence.

Yet a surgeon who spoke on the condition of anonymity said that since some authors are reporting tendon ruptures, he believed that "the nails are in its coffin." Fasciectomy or fasciotomy seem much safer, he added. The surgeon was not aware of any cases of neurolysis, but said that the occurrence is feasible.

Dr Bing Siang Gan, a surgeon at the Hand and Upper Limb Centre at the University of Western Ontario, agreed that any tendon rupture is one too many.

With nerve damage, the risk becomes higher as one injects distally, similar to traditional surgery, Kamineni explained. In over 1000 patients and over 700 injections, there was no nerve damage, Hurst said. Kaplan also described nerve injury as surprisingly low and added that no one reported temporary numbness.

However, in Dupuytren's, nothing is standard and predictable and while the cord can be palpated, it is not possible to feel the nerves so a physician would know where to inject but would not know where not to inject, Szabo cautioned.

There are different forms of collagen and some are resistant to collagenase, Meals said when asked about the potential for neurolysis. Some patients have experienced skin lacerations with Xiaflex, he noted.

One plastic surgeon noted that improper injection could result in serious consequences. If improperly injected into a digital artery, patients can lose a finger since Xiaflex works through dissolution, he said. He also noted that accidents may result in skin loss.

Vessel rupture is also a concern since many vessels are covered in collagen, said Kamineni, who explained that this could result in hematomas. There is a potential complication of hitting normal tissue with Xiaflex that is depends on on how and how often it is given, said Dr Scott Zashin, a rheumatologist and clinical associate professor of medicine at the University of Texas, Southwestern Medical School.

According to Sargent, while nerve damage appeared to be an issue in vitro, Xiaflex does not appear to affect the nerve, large arteries, or veins.

Kamineni said that lack of proper training is the "quickest way to go wrong" for the company but believed that Xiaflex genuinely has a place in treating Dupuytren's contracture.

Physicians are optimistic about approval, but there is a concern that problems may emerge if patients who do not need Xiaflex get treated with it due to the convenience of administration, Szabo said.

Meals agreed that hand surgeons were enthusiastic over the potential for Xiaflex, but noted that many adverse effects are often identified after an agent comes to market. However, he said that Xiaflex seems remarkably safe.
- http://www.ft.com/cms/s/2/aba2b8f0-7aee-11de-8c34-00144feabdc0,dwp_uuid=e8477cc4-c820-11db-b0dc-000b5df10621.html

Hawk

I think the board moderator here should split out all the xiafles posts from the migrated topic into one topic.

Who is up to being that person?

The problem is that I think the vast majority or those 1000 posts ARE on the topic of Xiaflex.  The 1000 post topic almost is a xiaflex topics.  My guess if you took out every post with Xiaflex, Auxillium, AA4500, that only about 100 post would remain.
Prostatectomy 2004, radiation 2009, currently 70 yrs old
After pills, injections, VED - Dr Eid, Titan 22cm implant 8/7/18
Hawk - Updated 10/27/18 - Peyronies Society Forums

newguy


Hmm, a difficult one. Having its own thread would ensure a present and future uninterrupted flow of discussion. Should Xiaflex be solely discussed in the developmental drugs thread then we could lose the fluidity of discussion should other treatments be mentioned. Still, as you say, most of the posts are about xiaflex. Maybe the essential xiaflex posts could be included in the xiaflex thread , rather than all of them (patient experiences, studies, company statements).

If we do decide to split all xiaflex posts from the current thread, would it be better to remove all non xiaflex posts from the existing 'Developmental drugs & treatments - Still in trial or not approved for Peyronies' thread? As there are far fewer non xiaflex posts, it'd just take a bit of thread renaming once the changes had been complete.

ComeBacKid

I think we should just keep it under developmental drugs and treatments, I've actually been disappointed with the amount of people posting who are in the trials, I thought there would be many more.  I don't think it really clogs up that topic, as it is the main thing we talk about in that topic really.  If you start splitting topics like crazy the discussion will lack in each topic. The only thing I could see that would make sense was a "Post here if your in or were in xiaflex trials" topic so guys can state what they are being given and we can ask them questions.  However, again, we really don't have enough guys for this in my opinion.

Comebackid

newguy

Quote from: ComeBacKid on August 31, 2009, 03:50:45 AM
I think we should just keep it under developmental drugs and treatments, I've actually been disappointed with the amount of people posting who are in the trials, I thought there would be many more.  I don't think it really clogs up that topic, as it is the main thing we talk about in that topic really.  

I agree, it's somewhat disappointing we don't get more feedback from those in the studies. It really would be helpful to the community. As for the other point, as my suggestion doesn't appear to be very popular maybe we should go with the path of least resistence for now then, and remove this thread. If Xiaflex becomes an actual widely used treatment at some point, then we can start a brand new thread/board elsewhere from that point anyway (since it will no longer be a developmental drug) and the older posts won't be as relevant.

Hawk

I agree that feed back is interesting chit chat but feedback on this study is of little value, possibly NO value in telling us anything about the effectiveness of the drug.  It may actually be WORSE than being of NO value. There is nothing of scientific worth from a bunch of people that have no clue what they were getting, trying to objectively report results.  Unless they know what they are getting, AND unless we are getting reports from ALL participants the value is at best negligible.  It is even likely worse than negligible and might well result in totally misleading conclusions.

Say 25 people post their results, 8 feel they see some improvement, 2 say they see definite improvement, 10 see no change and 5 say they think they have actually gotten worse.  What can you conclude?  Answer - anything you damn well choose to conclude.  Now factor in that there are a 100 participants that you are not hearing from.  They could all have improved, or all of them could have gotten worse, or any mix.

Frankly one of the most disappointing aspects of the PDS is our total failure of getting even members to move beyond non-scientific, irrational conclusions, based on data that is impossible to assess such as this information and anecdotal experiences.  We are still operating in the realm of a rabbit's foot and throwing a pinch of salt over our shoulder.

Finally, if 100 people began swapping data here on the trial it would stand to jeopardize the entire trial we have waited for so long.  We could not do one iota differently EVEN IF WE COULD ASSESS THE RESULTS.

Wait for the clinical assessment.
Prostatectomy 2004, radiation 2009, currently 70 yrs old
After pills, injections, VED - Dr Eid, Titan 22cm implant 8/7/18
Hawk - Updated 10/27/18 - Peyronies Society Forums

cowboyfood

Quote from: Hawk on August 31, 2009, 10:42:47 AM
I agree that feed back is interesting chit chat but feedback on this study is of little value, possibly NO value. It may actually be WORSE than NO value.

I agree completely with the above statement.  

I believe ANY preliminary suppositions from others regarding the Xiaflex trials based on alleged participant postings are irrelevant and harmful.

Additionally, I believe that alleged participant's posts are also irrelevant and harmful to the extent that the poster provides any information other than that they are participating.

CF
Currently:  L-Arginine (2g), Vit D3)

ComeBacKid

 I agree that it is tough to assess the feedback when people don't know what they are getting.  However if just two people came on here and said I had a bad bend beforehand and now its completely cured, that would be something worth noting.  At this point all we have is the video from the woman who had her finger cured.  Nothing is scientific at this point, sometimes I wonder if the studies done by the urologists are even scientific, especially the one done by Dr. Levine on the VED and Verapamil Injections.  I also remember a time when a bunch of clowns in texas claimed they had a specially patented delivery system for topical verapamil that was moving through FDA approval process.  They claimed high success rates on treating peyronies.  J and I did a report on this that raised significant questions, I don't really believe much of anything I read anymore...  A little positive feedback however, would be nice to hear from trial participants!  Someone is getting the real drug somewhere... I sure hope it is working...

Comebackid

LWillisjr

Quote from: ComeBacKid on August 31, 2009, 10:39:56 PM
Nothing is scientific at this point, sometimes I wonder if the studies done by the urologists are even scientific, especially the one done by Dr. Levine on the VED and Verapamil Injections.
Comebackid

What study did Levine do on VED's? I'm not aware of any.
Developed peyronies 2007 - 70 degree dorsal curve
Traction/MEDs/Injections/Surgery 2008 16 years Peyronies free now
My History

Hawk

Quote from: ComeBacKid on August 31, 2009, 10:39:56 PM
I agree that it is tough to assess the feedback when people don't know what they are getting.  

Actually it is impossible to assess.  Consider that even after knowing what the participants got it takes a considerable length of time to come up with conclusions.  Even if 2 people said the went from severe bend to straight, knowing the very conservative trial approach they are using you would have to wonder if it was the needle or rare spontaneous reversal.  In addition you still would not know if 2 got better, 150 remained the same and 50 got worse.

Face it!  The Information is not of ANY value to us in a sporadic, unscientific, blind form.  
Prostatectomy 2004, radiation 2009, currently 70 yrs old
After pills, injections, VED - Dr Eid, Titan 22cm implant 8/7/18
Hawk - Updated 10/27/18 - Peyronies Society Forums

j

Impossible to assess, but also - impossible to suppress.  That's what the internet has done for us - or to us:  eliminated the filtering and context-providing that used to be done by journalists.  Now,  participants in a trial can broadcast their results to the world the same day.  The doctors and drug companies won't like it, and will wish they could screen and edit those posts, or add explanations and corrections - but they can't.  People just have to learn to think critically and evaluate evidence on their own.   And yes I'm pessimistic about the chances of that happening.

A friend and fellow software writer once said that we're now in the Age of Information - which hopefully will be followed by the Age of Correct Information.

ComeBacKid

What makes this increasingly difficult, is the fact that even once they publish the results, assuming we withold judgement, each and every case of peyronies seems different, for example, many men complain of a lump and a bend, but my entire penis appears to be hard, like a cast around it.  

Does anyone know when the estimated publishing will be for these studies, so we can finally see if this drug is effective or not?  I believe this drug was being tested by a previous company for some 10 years where they did nothing with it...  

Comebackid

j

Quote from: ComeBacKid on September 02, 2009, 02:19:23 AM
What makes this increasingly difficult, is the fact that even once they publish the results, assuming we withold judgement, each and every case of peyronies seems different...

Comebackid

Yes.  With Dupuytren's it's simple - the finger either straightens or it doesn't. Diagnosis and measurement are straightforward. With Peyronie's it's hard to separate the effect of the fibrosis from many other factors affecting sexual function. So how can Xiaflex really be evaluated accurately unless the extent of the fibrosis is identified by some sort of imaging or tissue analysis?

MUSICMAN

Does anyone know if "Xiaflex" has been approved for use in Europe?

ohjb1

To try and answer some of your questions. I was in the study and was told that the Peyronies results will be make available in the 4th quarter of this year.  Other than that I don't know any more than you.

Xiaflex is not yet available in Europe. Everyone is waiting for the FDA to rule on Xiaflex for DC. The ruling should come shortly.  The recent article in the NEJM is promising for the approval in the case of DC, but who really knows how the FDA will rule.

The most important way to determine if Xiaflex works for Peyronies is to measure the curvature.  I had a number of penile ultrasounds and the urologist said they look different after the injections. This means nothing.  The only objective way to measure results is to measure the curvature of an erect penis.

Xiaflex was tested a number of years earlier, but the original company had financial problems and was unable to move forward.

 

ComeBacKid

Lets hope your right on the results being published in the fourth quarter and we get an early christmas present!

Comebackid

MUSICMAN

Sep 16, 2009   U.S. Food and Drug Administration's Arthritis Advisory Committee Votes Unanimously 12-0 to Recommend Approval of XIAFLEX(TM) for Dupuytren's Contracture.

I just took this off their web site. Does anyone know how long it might take to get the full FDA approval and then how long to go to market with the drug?

George999


UK

"The company is also studying Xiaflex for the penile disorder Peyronie's disease and frozen shoulder syndrome. Anido said the company does not expect to seek FDA approval for Peyronie's disease until at least 2011, and the shoulder indication possibly after that"

http://www.reuters.com/article/rbssPharmaceuticals%20-%20Diversified/idUSN1614796820090916

Can read into this that the Phase IIb did reach the desired results and Phase III will follow.

j

The part about "at least 2011" is really disappointing.  I wonder if it means Auxilium has gone as far as it's going to go without making some serious money off of Xiaflex.  They'll launch a major promotional campaign for Dupuytren's and set a very high initial price - probably just slightly under the cost of surgery - and after enough money rolls in, they'll get serious again about trials for Peyronie's.  

They may be in a bit of trouble. During the years they've spent grinding through the FDA approval process, a fairly simple, minimally invasive release technique for Dupuytren's called "needle aponeurotomy" has been steadily gaining acceptance and is now widely available.  This reduces the potential market for Xiaflex - maybe by a lot.  (I've already had this treatment myself).  If they can't make their earning projections for Dupuytren's treatment it may affect their ability to test and market Xiaflex for Peyronie's.

My interpretation of "at least 2011" is that there's no real committment.   As I understand it, Xiaflex could still be used off-label for Peyronie's - if any urologists are willing to try.


Jazz

Hi, all.  Just FYI.  We were told several months ago by one of the uros involved in the intital and Phase 2 studies that it would take years - first visit 'years, last visit, till 2011 or 2012. I do not mean to be discouraging - only repeating what we were told.  Not the uro my gentleman friend is having to do the surgery, but he is also one involved in the studies.  Actually gentleman's doc is doing part of the phase 3 study.   We did ask about off-label after it comes out for Dupuytren's.  First expert stressed that if you could find a uro to use it off-label, be VERY careful about who you go to, and that my gentleman friend's doc most likely won't use it off label  (he also said because of lawyers - lol, I'm a lawyer!)  .. inference being the top docs may not do that.  The ones not familiar with this condition may just jump on the bandwagon, but do more harm than good.  Makes sense to me.  If you have an expert that may be willing, okay.  Some docs that we saw that supposedly deal with both D and P had never even heard of Xiaflex, period.  Just be careful.

Jazz

ComeBacKid

Seems like xiaflex for peyronies keeps getting pushed back, isn't the peyronies report due out in the fourth quarter of this year?  

Perhaps they are moving forward and getting the drug approved and to market for the problem that has the most patients(and can sell the most and make the most money) first.  So there are more sufferers of peyronies then frozen shoulder, hence the 2nd and 3rd order.  We could be reading into this to much....

How can a lawyer sue if it is FDA approved and or if the patient signs away any right to sue, can't this be done?

Personally at this point I'm still not convinced it works for peyronies and am waiting to see the report and hear from some people on here who say it does work.  Looks like I better refill my pentox prescription, i just got a 6 month refill prescription, however I"m now sick with the flu for the 3rd time this year, and this time its really bad, feel like i'm a in a death camp.  In my entire life I havent had the flu this often in such a short time period, I wonder how safe it is to stay on pentox for long periods of time if it does indeed weaken the immune system.  

cowboyfood

Quote from: ComeBacKid on September 21, 2009, 10:34:43 PM

How can a lawyer sue if it is FDA approved and or if the patient signs away any right to sue, can't this be done?


"informed" consent is fertile legal grounds for a suit;

plus FDA approval notwithstanding, a physician could negligently or recklessly prescribe an FDA approved drug - (e.g., prosecutors are considering this theory for a charge of manslaughter/murder against one of Michael Jackson's physicians).

CF
Currently:  L-Arginine (2g), Vit D3)

ComeBacKid

Hmm,

Last time I checked "informed consent" was good enough to hold up in infant circumcision lawsuit cases where the infant didn't even have a say in what happened to him...  This kind of language sounds like its going down a path of lawyerism that will probably make my head spin and I won't understand.

I suppose a urologist coulde use xiaflex recklessly if he injected it into someones heart, but if hes injecting it by the FDA protocol into someones penis and they signed away the right to sue i dont see why they are worried.  While I do study and follow case law in criminal and constitutional law, I don't know a thing about civil law procedure and lawsuits for money.  This sounds like it could get confusing and complex with different interpretations by different people...

I'm sure some urologist will offer the treatment, I'm more concerned about if insurance will cover xiaflex for peyronies off-label.


cowboyfood

Quote from: ComeBacKid on September 22, 2009, 12:10:45 AM
Hmm,

This kind of language sounds like its going down a path of lawyerism that will probably make my head spin and I won't understand.


Of course, infants are legally incapable of consenting to just about anything.  And, informed consent requires the communication of all relevant information from the physician to the patient.  Xiaflex is so new, there may not be many doctors at this point even capable of providing informed consent for this drug.  

Keep in mind, most suits fall in the "grey" area of the law, not the "black and white" area.  Additionally, the law is constantly changing.  

Provided a suit is not frivolous (or, other similar characteristics), a civil complaint could be heard.  Whether it's a strong case or even a winner depends a lot on the respective counsel.  

Over 95% of ALL civil cases in this country are settled (never making it to trial).  So, it's hard to say if many or most of these cases would have "won" at trial.  

Settling a case brings certainty.

CF
Currently:  L-Arginine (2g), Vit D3)

ComeBacKid

You forgot to mention the one important fact regarding civil cases that I do know.

Unlike a criminal case where you need to prove guilt beyond a reasonable doubt, (reasonable varying from person to person).  In civil court one must only show a preponderance of the evidence.  This simply means that to prove that "something is more probable than not."   This standard of proof  is much easier, its no wonder many cases are settled then...

I think they need to come up with some kind of standard paperwork/form for those people who wish to waive rights to suit to try new and developmental drug.  I actually heard of someone who's kid had some diseases and they went to china for developmental stem cell treatment cause they couldn't try it in the united states.

comebackid

Hawk

Comeback,

You say "If a physician injects the penis according to the FDA protocol"

That is the issue.  If it is used "Off Label" that means there is NO approved FDA protocol for penile injections.  That is why there are more clinical trials for Peyronies Disease yet scheduled, because it is still in the approval process.
Prostatectomy 2004, radiation 2009, currently 70 yrs old
After pills, injections, VED - Dr Eid, Titan 22cm implant 8/7/18
Hawk - Updated 10/27/18 - Peyronies Society Forums

George999

I see trying to use a new drug such as Xiaflex that is somewhat invasive to boot in an off label application as a legal pandora's box.  No physician in their right mind is going to do it EXCEPT for PERHAPS Xiaflex experts participating directly or tangentially in the FDA approval process.  But just walking into a doctor's office and getting an off-label Xiaflex treatment is not going to happen here.  In Mexico perhaps, but not here.  And I would be the last one in the world recommending someone go to Mexico for treatment.  Look at it this way.  At least at this point you are probably still a potential candidate for surgery.  Things could be worse if you land in the hands of a nincompoop doctor with Xiaflex (or perhaps who knows what) in his syringe.  - George

j

Urologists are already prescribing an off-label drug treatment: transdermal verapamil. Unfortunately, it's worthless.   And it isn't necessarily harmless - it has systemic effects including alterations of blood pressure - so they're already taking some risk.  Quite a few people have now received Xiaflex injections over a number of years and no serious side effects have been noted.  If a high-profile urologist was willing to try Xiaflex, he might find a lot of guys running in the door with money in hand.  And with the knowledge he gained he might set himself up for nice consulting fees from Auxilium in the future.


Hawk

I agree, I think a doctor such as Lue, or Levine (but not necessarily them) might well decide to proceed.  Is is unlikely to pose more risk that Verapamil.  I think they are innovative enough to be up for the challenge.
Prostatectomy 2004, radiation 2009, currently 70 yrs old
After pills, injections, VED - Dr Eid, Titan 22cm implant 8/7/18
Hawk - Updated 10/27/18 - Peyronies Society Forums

George999

I would agree with that, guys.  When you talk about docs like Lue and Levine, they in my mind represent indirect involvement in Xiaflex research.  They live in a research environment and understand and respect the risks.  But I wouldn't go with any less than that.  Red flags are everywhere.  - George

j

It would be easy enough to just do a minimal injection, collect a few hundred bucks and remind the patient that he had nothing to lose.  Actually making this treatment work may require imaging, several carefully placed injections, and follow-up use of a traction device or a VED.    Fortunately, we have this forum, so we'll find out who's seriously trying to help their patients, and who simply sees this as the urological equivalent of the botox gold mine.

ohjb1

To J and Jazz. You should not be surprised about the 2011 or 2012 date.  If they go ahead, phase 3 will start next year and probably not finish until 2011.  This is always what they said and is their schedule.    

j

I guess I could interpret it that way, too. Hope you're right.  

ComeBacKid

Does anyone know when Auxilliums quarterly report is due out in December?  They have announced that they will publish the results of the peyronies study with xiaflex in the last quarter of 2009.  I'm wonder what we can expect as far to the details of the study, and if they might delay publishing this.  We have tried to "guess" the results by the little feedback we got on this forum from participants, and as some have pointed out, we can't really form a conclusion until we get all the results.  This study in my mind will be a huge indicator if the drug will ever make it to market for peyronies.  If we see vague language with no details, I would suspect a cover up of a failed study.  On the other hand, lots of details and good results will almost assure us that they will move forward with the drug.  This is a huge "fork in the road," moment for this drug and the future treamtn of peyronies.  Since no other major drug is in the pipeline, a lot of people's hope rides on the success of xiaflex.  I sure hope we hear positive news...


MUSICMAN

I think the last of the guys complete the phase IIb study the end of this month, Oct. 09. I am sure that it will take some time to crunch the numbers. It is my understanding that phase III is to start mid 2010. I do wonder how things are going with approval of Xiaflex for Dupuytren's contracture by the FDA.  

JPRHenry

For everybodys sake,  I sincerely hope there is great news for all!

newguy

Auxilium presented at a healthcare conference a few days ago. Apparently the "top line results of peyronie's phase IIb study are due Dec 09" and initiation of peyronie's phase III studies starts in 2010.


bones54

and had the pericardial patch this past week...
no change in my 70 degree bend...
i believe in my study group there was 1 person that improved from 60 to 30 and that was THE highlight of the 10 man group..

no miracles in chicago.

ComeBacKid

Quote from: bones54 on November 11, 2009, 04:54:17 PM
and had the pericardial patch this past week...


Whats the pericardial patch?

So you saw no change in your bend? Still though, only 10 people we can't draw results from this.

Comebackid

j

Yesterday, on a Dupuytren's forum which I follow, someone who had been a patient in the Phase III Xiaflex study (for Dupuytren's) posted some very positive comments. One thing he/she said was: "Treatment with xiaflex is no different than surgery or NA. The success rate is dependent on the skill of your doctor. Get a bad one, and you should expect a bad result. Luckily, my doctor was excellent and had excellent results."  


ComeBacKid

J,

Thanks for your post, its great to hear this positive news! I' d imagine the injection skill does matter.  Which brings me to my question for anyone who has gotten the xiaflex injections.  Is it a light "dab" shot like a tetnus , or do they inject the needle way into your penis?  Seems like you'd need lots of "light dabs" all around the penis in my case, since it is like a cast of scar tissue.

Comebackid

newguy

Quote from: j on November 14, 2009, 11:31:34 PM
Yesterday, on a Dupuytren's forum which I follow, someone who had been a patient in the Phase III Xiaflex study (for Dupuytren's) posted some very positive comments. One thing he/she said was: "Treatment with xiaflex is no different than surgery or NA. The success rate is dependent on the skill of your doctor. Get a bad one, and you should expect a bad result. Luckily, my doctor was excellent and had excellent results."  



Due to differences in dupuytrens and peyronie's it seems to me that there's more scope for very dramatic success through xiaflex use in dupuytrens. That's not to say that it doesn't hold any use for peyronie's, and what you say about getting a good doctor is a very relevant point.

I see Xiaflex for peyronie's as another potential tool that will improve our situation in addition to the mechanical (ved, traction) and oral supplement (pentox etc) route. Of course this is just my take. I'm looking forward to seeing more Xiaflex results published :).

j

Quote from: newguy on November 15, 2009, 02:09:28 PM
Due to differences in dupuytrens and peyronie's it seems to me that there's more scope for very dramatic success through xiaflex use in dupuytrens.
I think that's true, but success in either case depends on the doctor understanding exactly where the bad tissue is, and how and where it's hanging you up.  Xiaflex will be used by hand surgeons who have detailed knowledge of the hand's inner workings.  The good ones will figure out where they can best release a contracture with minimal collateral damage. If a urologists just walks into the room, shakes your hand and injects some Xiaflex, I wouldn't expect much.  But if a surgeon, guided by imaging, figures out where you're 'bound' and injects in the right spot - and follows up with stretching - the results could be good.  If your problematic area is large and diffuse, a different technique would be needed.

Basically Xiaflex 'eats' the fibrotic tissue.  It's a new tool, and now people have to figure out how to use it.


ComeBacKid

J,

You say xiaflex "eats" the fibrotic tissue, it must do this while leaving good healthy tissue alone.  My question is once the bad tissue is "eaten," is it gone forever, ist it replaced?

Comebackid

UK

Not sure if this has been posted before but it gives good info on the working of Collagenese (Xiaflex)

http://www.springerlink.com/content/w186814545008546/fulltext.pdf

my basic interpretation is good tissue is left alone. As for disolving tissue I don't know, I think it rearranges the collagen fibres by breaking their structure, I'd hope restoring some of the original elasticity.

4-5 weeks and results of Phase IIb trial should be announced.

j

Here's what I think I know:  Xiaflex is a form of collagenase,  an enzyme that breaks up (metabolizes, dissolves, "eats") collagen. There are several types of collagen, and the action of Xiaflex is at least somewhate specific to the type of collagen found in Dupuytren's/Peyronie's tissue.  It doesn't distinguish "good" from "bad" per se, and the unwanted collagen is of a type also found elsewhere in your body in normal tissues, possibly even close to the "bad" tissue.  So, it has to be used with care. The idea is to inject just enough to do the job and not escape into surrounding tissue.

At this point, it would be great if someone with real knowledge (say, someone from Auxilium) would jump in and correct any errors or misinformation I'm spreading.  However that isn't likely to happen, so we're left to speculate based on whatever information we can obtain.


rockwall

I think that if collagenase/Xiaflex does not harm non-peyronie's tissue that a transdermal approach miight be an effective conservative approach. I understand that it has a low enough mollecular weightto pass through the skin. What do you guys think?

Rockwall

j

My understanding is that it can in fact harm "good" tissue and needs to be carefully targeted.  Auxilium already has a topical collagenase product called Santyl that is used to reduce scarring in wound healing. They've just spent millions developing Xiaflex which is  basically an injectable form of collagenase.  If Santyl had any usefullness against Peyronie's, they'd already be marketing it.

rockwall

Well J I have already tried it with Santyl some time back. I would apply the ointment over the plaque, rub it in, then cover the area with a cotton patch soaked in DMSO and soak with a plastic wrap over the top for about an hour. I can't say that it helped but also can't say that it hurt. It did change the underlying structure temporarily to a sort of ropey look. It did not appear to harm the skin. It believe that this product is mixed with petroleum jelly and I thought that not enough of the enzyme might be in a free enough form to penetrate effectively. I did this for at least a month on two separate occasions. I stopped both times due to scheduling problems and not application problems. I do not want to encourage others if damage is possible but, this was my experience. I have wondered why Auxilium have marketed through Uros with injectables and not for topical home treatment.

Rockwall