Developmental drugs & treatments - Still in trial or not approved for Peyronies

[jon]

Clinical Trial update:
I'll be in Houston on Monday for the initial screening. As soon as I know if I'm in the study or not, I'll let everyone know.

[Tim468]

UK,

I doubt VED use would affect the results for later use of Xiaflex. If I were doing a study, I would like to treat pristine and previosuly untreated Peyronie's, to really see what my thing could do. The study is designed to exclude those using other methods of cure simultaneously (ie VED) and demands that you not have done any other such therapy for a period of time before entry into study (can't recall if it was 3 or 6 months).

Tim

[jon]

Tim:
It's 2 weeks.

Used any mechanical type device for correction of Peyronie's disease within the 2-week period before screening or plans to use any these devices at any time during the study
Used a mechanical device to induce a passive erection within the 2-week period before screening or plans to use any of these devices at any time during the study

[G.]

All,

I had my first injection today, as part of the Xiaflex study.  My doctor mentioned that he still had slots available for five more participants, that there was a 10-day window remaining to get into this study, and asked if I knew any men who'd be interested in participating.  I mentioned this forum and he OK'ed my posting this info.

His name is Dr. Ridwan Shabsigh, and he's the head of the Urology department at Maimonides Medical Center in Brooklyn, NY.  If anyone is interested in participating, you can contact his study coordinator, Kimberly.  Her number is 718 283-7634.

A few things worth noting, that were discussed previously here:  the consent form says you have a 3:1 chance of receiving the study drug, versus the placebo.  I reported here previously that I'd had verbal assurances from the Dr. and his study coordinator, that the drug would be made available at the end of the study.  But when I raised the point today, in the context of mentioning it on this forum, he backed off and said he couldn't assure that.  He said he hoped that he would be able to make the drug available at the end of the study, but he wouldn't guarantee it.

My personal take is that by participating in the study, I've got a 3:1 chance of getting the actual treatment, and if I'm in the placebo group, there's still a chance I'll get the treatment at the end of the study.  If I don't participate in the study, I've got zero chance of getting the actual treatment.  The calculus would of course be different if you have to incur the expense of flying in, etc - the study requires numerous visits.

Last, I'll just say that notwithstanding the Dr.'s waffling about the placebo group getting the study drug, overall I completely trust his skill as a doctor, in particular his experience with Peyronie's.  His research coordinator is also very professional and easy to work with.

So if there are any guys within reach of the NY area, who've been on the fence about getting involved in this study, here's a chance to do something.

G.

[Hawk]

G.,

Thanks for the great post.  This is one of the many benefits the PDS forum was setup to facilitate.

[Believer]

G,

Thanks for the post. Can you please describe how the injection went? Was it painful? Was it a single injection? Did you develop a hematoma (bruising) at the injection site? Are you able to see any immediate results? If not, when should you expect to see them if you received Xiaflex? Thanks!

[jon]

G.

are you in the modelling or non-modelling group?

[G.]

Hi Believer,

The injection was a single injection (directed at the location of maximum curvature/thickness of plaque), and yes, it was fairly painful.  Not eyes tearing, can't stand it painful, but definitely not fun!  Fortunately, it was over in a matter of seconds.  The doctor did offer to administer an anesthetic first, but pointed out that that would be an injection too, so I figured, let's just get it over with.  Not sure if I'll ask for anesthetic when I go back for second shot on Monday; depends on how sore it is then, I guess.  If it's any help, this doctor really knows what he's doing.

I definitely have some soreness there, but not severe.  There's a small lump on the shaft of the penis, under the skin, where the injection was.  I have no idea yet whether got the real thing or not, I figure it would be sore either way, after getting an injection there.  Also, this happened earlier today, so I haven't had any opportunity to see how this may have affected my erection - probably it would be way too soon to tell, anyway.  I'll post back if I see anything significant after I get the second injection.

A couple of other things that may be worth mentioning, if you're considering participating in the study:

- It says in the consent form that they expect you can resume normal sexual activity two weeks after each treatment (i.e. second injection in a series).  I'm going to ask the doctor on Monday whether that precludes all sexual activity of any kind, because going two weeks without any relief in that department is kinda hard!

- You also have to agree that if you're sexually active during the duration of the study, that you have to use contraception.  I suspect this has more to do with avoiding liability on their part than with any real risk, but regardless, you have to agree to that to participate.

jon, just saw your reply when I was about to post this.  I'm in the modeling group.  This means I have to go in for a third time (this coming Wednesday, after injections Saturday and Monday).  They said I would be shown a video, and then the doctor would do this modeling on me (which I gather is some kind of stretching) and then show me how to do it myself.  I'll then be expected to follow up with doing this at home.  Actually, I'm glad to be in the modeling group - I figure if it increases my chances of improvement, it's worth trying.

hth,
G.

[jon]

G.

I'm going in for my initial screening on Monday, how did that go for you?

Like you, if I make it into the study, I'm hoping to 1) get the real thing and 2) be in the modelling group, but I'll be happy to just get the real thing, since I'm driving 270 miles each way to participate.

[G.]

jon,

Looks like our posts crossed.  The screening was not a big deal, mainly taking blood, urine etc.  I guess the biggest deal is that he gives you a (non-painful) injection to induce an erection, and then he examines you with an ultra-sound device.  I had had this same procedure 3 years ago when I first consulted this doctor for my Peyronie's (same doctor who is running the study I'm in), so I knew what to expect, like I said, not a big deal - in fact, the experience makes for a good war story!

Good luck, hope you get in.

G.

[roadblock]

As always, I am curious to hear from those of you who have by now received more than one treatment with (possibly) Xiaflex...as long as it does not jeopardize your ongoing participation in the trial to do so!

Also, pirfenidone...seems like now would be the time for all of us to collectively alert the company to the plight of us here and everywhere with Peyronies Disease and see if they might not further investigate whether we could be yet another population of patients who could benefit from the drug. It seems that it will likely be available sooner than Xiaflex even, and although it will most likely not reverse what is already done it could be the preventive drug we have been hoping for.  

[JPRHenry]

Thanks everyone for all of your input.  I'm still not good at navigating on this site, so please bear with me.  Recently, I applied for pre-authorization for surgery.  It was denied.  I filed an appeal and asked the physician to please file jointly.  Looking forward, if the appeal fails, I suppose I will attempt to negociate "price", and if that fails, I suppose I will be resigned to a "wait and see" approach, hoping Xiaflex is everything many of us hope it will be.  In the meantime,  I am very, very interested in hearing from many of you that have been in the Xiaflex study, especially those that have received more than one injection.  Hopefully,.. you will be able to report positive results.  Thanking all of you in advance for keeping the "lines of communication" open and flowing.  John.

[jon]

I get to go back on January 9th for the doppler/utrasound and bloodwork. But so far so good for meeting the inclusion criteria and not hitting anything on the exclusion list. So nothing really to report yet aside from my plaque measurement via micrometer: 12mm x 56.5mm

[UK]

Hi, I just got back from my visit to my UK urologist who is supposedly the Peyronie's expert in the UK. I asked him what he knew about Xiaflex and how he thought colleganese worked. He said he had asked to be included in the trials but had not heard anything back from Auxilium. What he told me was pretty negative and not how I had understood it to work. This is exactly what he said - the collagenese would dissolve the fibrosis, the penis would be stretched and the fibrosis would be replaced with further scar tissue but in the stretched form. He said in his opinion it was highly unlikely that healthy tissue would form or scar tissue could be remodelled into healthy tissue.

I was basing my understanding on the information in this link, so obviously his comments did not fill me with hope.

http://books.google.co.uk/books?id=fLlNmRPzaEEC&pg=PA83&lpg=PA83&dq=collagenase+peyronie's+60%25&source=web&ots=bFDjs8eZXs&sig=VY-ih9k_PMQPqk6dB5NnNqz1VZk&hl=en&sa=X&oi=book_result&resnum=4&ct=result

Also the previous Phase I/II Auxilium trials were not with modeling which I believe he was referring to.

Is he misinformed or not as much an expert as his reputation is made out to be? One of the posters that had underwent the injections mentioned the dent had been reduced (after days), surely that is a sign of elasticity returning and not new fibrosis forming. Wouldn't the new fibrosis take months to form, so what is replacing the dissolved scar tissue? Positive comments appreciated as I am feeling really negative right now and this was really my only true hope of reversing some of the damage.

[j]

UK, my own (layman's) interpretation of what he said would be more positive.

Xiaflex can't stop the underlying process that's causing the fibrosis - whatever that actually is.  It can dissolve existing collagen deposits, which would restore some elasticity, at least temporarily.  Stretching the tissue would be a way to retain the gains in straightness and length even if elasticity is lost again over time. The progression of Peyronies Disease is unpredictable, so I think it's quite possible that the fibrosis doesn't recurr, at least for a long time.

My understanding is that the treatment should be repeatable, if necessary, as time goes by.

[ohjb1]

The fact is no one really knows if stretching or modeling will help to lessen the curvature. Auxilium's modeling may or may not be the correct approach.  We will have to wait for results of the trial to find out.

[G.]

Speaking to the topic of modeling - I just had my first session of that today, as part of the Xiaflex trial, so will relate how it was explained to me:  what I was told was that it was hoped that the injected drug would break down and/or weaken the fibrous tissue.  The rationale for the stretching was that, with the fibrous tissue weakened or broken down by the drug, that the stretching would break down the fibrous tissue even further.  There was some mention that the results of the earlier trials supported this theory (i.e. apparently some men in the earlier trials did this stretching too), but they didn't go into details. They also didn't go into detail as to what kind of tissue would replace that, and I didn't think to ask.  The rationale given seemed logical to me, and the stretching technique I was shown seems well-designed, so I'll stick with the program and see what happens.

Following up on my post of a few days ago, I had my second injection on Monday, and this didn't go too well - basically I ended up with a hematoma a couple of hours later and was in a fair bit of pain for a couple of days.  Fortunately it's getting better.  Not knowing anything about the topic, when I initially saw this happening, I figured at least this must mean I got the drug rather than the placebo.  But what I've learned in the past couple of days, and confirmed by the doctor, is that the hematoma had nothing to do with the drug or placebo - it was just that a blood vessel got nicked in the course of the injection.  It was suggested that when I get the next set of injections, I should be more careful about applying firm pressure for several minutes afterward, which I definitely did not do this time.  Apparently the second injection in a series, is often tougher due to the after-affects of the first injection still being present.  They didn't seem at all surprised this had happened.

With all this going on, the opportunity to examine my curve didn't arise until this morning, and there's no change in the curve at all (at least it's not worse!).  So at the moment I'm thinking I may be in the placebo group, and am a little bummed about that, but I'm definitely committed to stick with the program and see what happens.

G.  

[Hawk]

basically I ended up with a hematoma a couple of hours later and was in a fair bit of pain for a couple of days. ...the hematoma had nothing to do with the drug or placebo - it was just that a blood vessel got nicked in the course of the injection.  It was suggested that when I get the next set of injections, I should be more careful about applying firm pressure for several minutes afterward, which I definitely did not do this time.  

G,

Do not underestimate the importance of applying this pressure.  The hematoma can form under the skin, in the cavernosa, or anywhere else in the penis structure.  From what I have read, whole blood in any tissue can trigger formation of scar tissue, or adhesions or (plaque) and it is an issue in surgery in general.  I strongly suggest you make sure you apply that pressure to prevent bleeding into the tissue.

[j]

I guess I misunderstood what UK was saying. I was thinking of long-term stretching, after the Xiaflex treatment, as a maintenance program.  Apparently what they're doing in the trial is similar to what they do with Dupuytren's - inject, wait a while and then stretch right on the spot.   It makes sense either way.  After Dupuytren's surgery you wear a night splint for months so you don't lose what you've gained.

[G.]

Hawk,

Thanks for reply - I'll definitely be on top of this next time I get injected.  Reconstructing events, the doctor told me to apply firm pressure for a few minutes, then a minute later told me I could get up and get dressed, so I obeyed.  He's a great doctor, but with the caseload of this study on top of his regular practice, he does seem rushed these days.

On the day I got the first injection, I had asked him whether there was any concern that anyone in the placebo group might actually be harmed, due to bruising or some other reaction to the injection.  He said no one in the placebo groups in any of the earlier studies, had any adverse affect on their condition.  Hopefully, I won't be an exception. Fortunately, I'm a quick healer so I'm optimistic this won't have any lasting effect.

G.

PS:  Want to clarify something I posted a few days ago, about resuming normal sexual activity 2 weeks after the second injection.  I asked the doctor about this; he said I could do whatever I was comfortable with, the language about 2 weeks was just to say that at the max, you'd be able to resume sexual activity by that timeframe.

[ComeBacKid]

I guess for me I'd be concerned over getting the placebo, which one does not know if they are getting or not.  I say this because just getting injections with no medicine can't be good.  As we saw in our survey most people who got verapamil injections saw no improvement and some got worse.  I just can't see how stabbing a needle into the penis will cure anything and only create more scar tissue.  I'd be very reluctant to join any trial study because of this.  Nonetheless, someones got to to do it to get this ball rolling.  It will be very interesting to see the final results of this study.

Comeback

[UK]

Something is happening with Auxilium stock last few days, Tuesday up 10%, Wednesday up 6% and today opened up 18%.
Could there be some news on the horizon?

[UK]

That's it, Pfizer has bought the rights to Xiaflex, could this be a breakthrough for all of us or a hindrance.

[G.]

Wow - that is a big deal.  Link to article:  http://money.cnn.com/news/newsfeeds/articles/marketwire/0461453.htm

This can only be good news. For starters, it validates that Auxilium has got a viable product with real potential - Pfizer is not going to make that kind of investment unless they see the science as sound, and see commercial potential.  It also means that Auxilium is not going to run out of money and/or go out of business before the product gets to market.  And having Pfizer as a strategic partner should definitely help in getting the product through the approval process.

In the article, both the Auxilium and the Pfizer people talk about the potential for Xiaflex in treating Peyronie's as well as Depuytren's - so this is also noteworthy in getting Peyronie's attention as a 'mainstream' disease:

"Today, Pfizer and Auxilium have forged a compelling partnership and together we believe we have the opportunity to offer the first, effective non-surgical treatment for two diseases," said Armando Anido, Chief Executive Officer and President of Auxilium. "With the strength of Pfizer's commercialization and development organization, this relationship greatly enhances our ability to effectively introduce this potentially groundbreaking technology for the treatment of Dupuytren's contracture and Peyronie's disease in Europe."

G.

[George999]

Pfizer spells $$$$$$$$$ for Auxilium.  This means Phizer thinks Xiaflex is ready for the fast track for both Dupuytren's contracture and Peyronie's disease.  And nobody knows better than the big drug pushers like Pfizer how to get a potentially money making product on the market in no time.  Money moves mountains and Pfizer has what it takes.  Pfizer also knows very well that these are two diseases with simply no proven effective treatment at this point which means success on the part of Xiaflex has the potential to enrich Pfizer in return.  - George

[Old Man]

G:

Am I reading the last sentences in the excerpt of the article where is says in Europe right or not? ?What about the good old USA?

Is there any reference to its being available in the U.S. anywhre in the article??

Old Man

[George999]

Old Man,  I don't really think that makes a whole lot of difference.  Just the fact that Pfizer is along for the ride on this will add money to Auxilliam's coffers and be influential with the powers that be.  And I think it will guarantee its introduction to the US market at a time when the success of this product was not guaranteed previously due to financial vulnerability on the part of Auxilliam.  - George

[didi20031]

Old Man
Good old USA? I thought it was good old Europe... ;-) Sorry, just kidding!

[Ted Williams]

Hey folks:  

Pfizer jumping in is a great thing.  With regards to Europe, often times, approval for a drug happens quicker in Europe then it does in the U.S.  Many companies start marketing and sales in Europe to maximize profit.  I'll fly to France for this stuff!  This is also about distribution.  A company like Pfizer has a massive capacity for distribution and they are also a U.S. company.  There is probably a connection just in the ability to do business because they are both U.S. companies.  Auxillium does the research and manufacturing.  Pfizer does the marketing and distribution.  I don't know if Pfizer has a urological field force in the U.S.  

As for the doctor that said "it was highly unlikely that healthy tissue would form or scar tissue could be remodelled into healthy tissue" is odd.  The tunica albuginea is two sheaths of tissue and the scar forms between them.  At the site of the injury, it actually isn't supposed to deteriorate the scar.  It is supposed to break down the excessive formation of the tissue.  

The doctor's statement doesn't seem to comport with the literature.  Hmmmmmmmmmmmmmmmmmmmm.... and older doctor with habits giving out half-assed information to a patient that is more knowledgable then them on a particular treatment?  That never happens!  

Keep the faith!  Xiaflex is coming.

[Iceman]

will it make it downunder?

[George999]

As for the doctor that said "it was highly unlikely that healthy tissue would form or scar tissue could be remodelled into healthy tissue" is odd.  The tunica albuginea is two sheaths of tissue and the scar forms between them.  At the site of the injury, it actually isn't supposed to deteriorate the scar.  It is supposed to break down the excessive formation of the tissue.  

The doctor's statement doesn't seem to comport with the literature.  Hmmmmmmmmmmmmmmmmmmmm.... and older doctor with habits giving out half-assed information to a patient that is more knowledgable then them on a particular treatment?  That never happens!

I could recall a long list of famous assertions by doctors extending all the way back to Pasteur, who as a chemist knew more about what he was doing than most of the medical establishment of his day.  Then there were the medical experts who insisted that surgery on the heart would NEVER be possible.  AND the crazy docs in Australia who had the audacity to attribute ulcers to a bacterial infection when every doc worth his salt KNEW that ulcers were caused by stress.  And for years it has been boilerplate in the medical community that damaged hearts have to be replaced with transplants because a damaged heart CAN'T heal, until a damaged heart was left in with a transplanted heart due to extenuating circumstances and ... lo and behold the damaged heart got well.  Now the urologists are turning up their noses at the use of Pentox to treat Peyronies and the general practice docs are resisting the emerging research on Vitamin D in the amount of literally thousands of studies, 99% of which point in only one direction.  Its truly amazing how "evidence based" practitioners get bound up in myths.  They come to conclusions without any real evidence and then repeat them to each other for so long that they eventually end up believing them to a point of religious conviction and they fight if somebody comes along trying to confuse them with facts.  And so it is with the lowly tunica.  The realities of physiology be damned, they have an opinion  and nobody is going to stop them from expressing it no matter whether it actually makes sense or not.  Thanks for all your great posts, they are right on the money.  So great to have you contributing to the forum!  - George

PS - pdpunk thinks we hate doctors around here.  He couldn't be further from the truth.  We esteem doctors very highly.  But we have to admit that on occasion they are our favorite form of entertainment.  Gee ... they must be human!  (Just like us.)  Highly educated, highly trained, highly skilled, but still quite human.  And that is a GOOD thing!  But it does have a downside now and then.  We accept them with their foibles and we sincerely hope that they will accept us with ours!

[Tim468]

Although I believe that the incidence of Peyronie's is greater than recognized, and that many men could benefit from a "cure" (I do not think that Xiaflex shall prove to be a cure - it will help some but not all, I bet), this is small potatoes compared to heart disease and cancer.

Pfizer may well have bought the rights to eliminate competition - it happens. Drug companies sit on drug development if it is not going to be a homerun; Pfizer is more likely to do that than a small company that is only making one or two drugs.

We shall see - I would be more interested in who is making money by the stock options that are flying about than who is going to see the light and start to make Xiaflex available sooner (or not).

Tim

[George999]

We had such a good roll going here until who should show up?  The devil's advocate it seems in the form of our own Dr. Tim!  So ... Tim ... now that you are throwing this cup of cold water in our laps, do you actually know of some prescription med for Peyronies made by Pfizer?  The only Peyronies med I know of at this point is Potaba which is made by Glenwood.  Or perhaps Pfizer has some killer Peyronies product ready to launch?  The plot thickens!  Tell us more o wise oracle!  - George

[LWillisjr]

I have to agree with Tim. It isn't that often that there is that single cure all drug for everyone. I hope I"m wrong. Does anyone know how well Xiaflex works for Deputryn's Disease? Maybe the success rate will be similar.

Les

[George999]

For the record, as far as THE cure is concerned, I agree with Tim also.  I think Xiaflex has the potential to be a great tool, but the cure lies much deeper than just burning off some collagen.  You also have to stop the collagen from returning.  - George

[Vernon21]

Guys,
I've followed some of the posts and I hope to have some more feedback in the next month or so once I've had another evaluation and have better idea where I stand.  I think I have gotten the real drug but there is no way to know for sure.  Regardless of what I got and as hopefull as we all are, everyone should have realistic expectations.  Based on what I've heard from my doctor, the assistant and my own experience I think Xiaflex can be helpful in varying degrees to most of us.  It breaks up tissue but not necessarily evenly and the same for everyone.  Any progress should be looked at as the glass is half full not half empty.  I agree with what was said that it is not a cure.  Expect progress but not to have your plaque magically and evenly melt away like a pat of warm butter.  I think it could be a great advancement and I would definitely seek it out, but I don't expect to be back to the way I was at least in 3 series if at all.  I'm just one of many so anyone else please jump here.  I don't want anyone to be discouraged but I sense some euphoria and I think everyone should be hopeful and confident but not unrealistic.  I am also confident that my doctor and others will use Xiaflex as on off label use for Peyronie's once it is approved for Dupuytren's.  It will most likely be approved in Europe first.

[Ted Williams]

Hello Vernon,

Thanks for keeping things realistic.  I appreciate your candid evaluation of your own condition and experience with the Xiaflex Trials.  I always imagined that Xiaflex would break up the big blocks of fibrotic material, but in the end, it would be our responsibility to follow up with VED, supplements, Pentox and whatever we have discovered to address the condition further.  

Please forgive me if I made slights at the doctors on the front-line of our battle.  Peyronie's is one of many conditions that these doctors deal with.  The deluge of theoretical and experimental treatments for all of the conditions they confront is overwhelming.  I don't expect them to know everything.  I hope that the recent moves made by Auxillium will enhance the profile of this treatment.  

I am hopeful for a powerful, non-surgical tool in our tool box.  

Keep us posted.  

Ted Williams.

[Tim468]

I don't know of any Pfizer drugs. I was thinking of Intermune that stopped studying Pirfenidone when they had Actimmune that seemed to help. A patient filed suit to force them to give pirfenidone under compassionate use, and then extended it to try to force them to study it - even though it was possible it would undermine their treatment (and revenue stream) from using their other drug (Actimmune) for IPF. See, I think Pirfenidone would not have made them as much money, and it looked like they were going to sit on it until the patent for Actimmune ran out to ramp up work on Pirefnidone.

So, no inside information, but for now, the amount of income from Xiaflex to Pfizer would be like the leftover money for the office coffee fund would be for me at the end of the month.

Tim

[jackisback]

Is there indication that InterMune is still sitting on this? It is listed on their product pipeline, and has just been approved in Japan.

[George999]

Jack, They WERE sitting on it.  Basically, dying IPF patients and their families made enough of a stink to make them continue development of Pirfenidone.  - George

[j]

My own somewhat cynical analysis:

When a major corporate player decides it wants in on something, it's hardly ever a good thing for the public. These people are only interested in really-big-money plays, and their timelines are in decades.  Any immediate benefits to us, the patients, would be purely a side effect.

Their stated intention seems to be to market Xiaflex in Europe, and leave the US to Auxilium.  But I have doubts about that statement; at best, it just describes the initial agreement.  Pfizer could simply buy out Auxilium at any time, toss Auxilium's plans into the waste bin and start over with a whole new marketing, distribution and pricing scheme that would take years to implement. And as tim468 points out, one nasty but real possibility is that they simply kill the product

There's no way to know.  The combination of our stock market, our intellectual property laws, our madness for litigation - plus corporate and individual greed - can be a toxic mix.

[G.]

While cynicism about the major drug companies is warranted many times over, in this case I don't see the benefit to Pfizer to acquire Auxilium and then just kill the product.  For one thing, there's been reporting that the major drug companies are running out of new prospects in their own pipelines, and many of their big profit-makers are going to go off-patent in the next few years.  So they're actively looking for new products, particularly in biotech - see this article, for example:  http://money.cnn.com/news/newsfeeds/articles/djf500/200812161237DOWJONESDJONLINE000576_FORTUNE5.htm.

For another thing, although the income from Xiaflex would never rise to the blockbuster category, it could prove to be very profitable.  I thought I read somewhere that when this was commercially available, it was expected to cost in the neighborhood of $11,000 (did I read that on this board, some time ago?).  Anyway, let's say eventually 50,000 men per year were getting this treatment worldwide.  If $2000 per patient flowed back to Pfizer, that would be $100 million per year in revenue, just for this one application.  Even if the number were lower than that, it would still potentially be very profitable.  And unlike the Intermune example cited, there's no evidence that Pfizer has any competing product in their pipeline - so, hard as it is for me not to suspect the motives of a big drug company, it's hard to see why they would kill or delay Xiaflex in this case.  

G.

[MUSICMAN]

The way I do my business I need correct, up to date, factual information
in order to make decisions. "What if",  "Maybe they" does not help. Solid
information is what we need.

[Tim468]

I know that inhaled TOBi is worth 300 million a year to Novartis, and they think of that as the "office coffee funds left over at the end of the month" (that is a quote from a man I know working at Genentech). I do not think that most of us can even THINK in terms of how much money big Pharma makes, such that 100 million a year is nothing to them.

The main reason to buy and sell companies is to manipulate stock prices - I note that the stock value went up fast, and before the financial agreement was announced. That sounds like speculation and probable insider trading to me.


Tim

[j]

Giants like Pfizer are always interested in picking up companies and products that they think might turn into big money-makers.  Sometimes they decide later that the really big bucks aren't there after all, and they lose interest, and the product never happens.  Even if they decide to go ahead, they move slowly - Auxilium's success has depended on Xiaflex moving forward; Pfizer's would not.

Dupuytren's Contracture is a very common condition especially among older people, and as far as I know there's no product in development that competes directly with Xiaflex.  If Xiaflex can replace a lot of surgery, at a cost that's only somewhat lower, there's probably some serious money.  I think it will happen.

[rbwoodward]

I propose starting a new discussion thread here for participants in the Xiaflex trial.  

My background:  I am 57 y.o., going into the trial with a curvature of about 40 degrees.  Sexual intercourse has been hindered, but thankfully still possible.  I am recently enrolled and have completed my first round of injections.  My doc is a well regarded guy in the field and is the go-to physician in my area for Peyronie's.  The injection procedure was no big deal.  My penis was completely numbed and I never felt a thing beyond the initial injection of the local anesthetic.  Thus far I have experienced a lot of bruising and swelling which I was told to expect.  After 3-4 days these symptoms are decreasing.  Though not particularly enjoyable at this time for obvious reasons,  I have had small erections which have produced a distinct tugging sensation in my penis.  I hope that is indicative of the collagen breaking up.  Based on these observations, I am pretty certain that I am not getting placebo so I am very happy about that.  All in all, it has been tolerable so far.

Other participants-please post your experiences.  Thanks and good luck to all.
rbwoodward

[ComeBacKid]

What is the course of injections, you get one weekly, every two weeks etc? What region of the usa are you located in?  I like the idea of starting a thread on this to compare experiences, I'm unsure of exactly how many members in our forum are in the clinical trials.  Have you tried any other treatments before this, and if so what results did you see or not see?

Comebackid

[newguy]

There is a concern that should there be a seperate Xiaflex thread, everyone will post in there and this thread will die out, or there will be cross posting etc. I can see how that could be a problem. There does appear to be great interest in the Xiaflex trials though, so maybe there could be a Xiaflex thread specific to those currently receiving treatment to detail their progress (or lack of) and ongoing experience. In this thread (development drugs and treatments) we could then ask followup questions concerning the Xiaflex thread updates, but the Xiaflex thread itself would be an uninterupted thread consisting of treatment updates and thoughts from only those involved in the clinical trials. This would make it very easy to get a feel for how the trials are going, and also may make it more likely that newcomers and lurkers receiving Xiaflex will post since the thread will relate very specifically to their situation. Just my view.

[rbwoodward]

I understand newguy's concerns about starting a new thread.  It does not really matter to me, whatever works for the group is fine.  

To comeback kid:  The first round of two injections is given over 24-72 hours, I believe.  I am not sure when the next round comes, probably in a few weeks.  I have not tried any other treatments.  There are lots of trial sites around the US.  Does anybody know the url for the listing of those sites?

[ohjb1]

rbwoodward - http://clinicaltrials.gov/ct2/search  and then type in Peyronies