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

Previous topic - Next topic

0 Members and 2 Guests are viewing this topic.

bones54

completed the last of the xiaflex 6 weeks ago......flew into chicago last night...caverjet injection..measurement...cabby back to airport...fly back home..parking lot payment...pay the babysitter.....5 hundy all told...

my angle has increased 5 degrees since beginning treatment.

cannot have any surgery until ive completed the last 2 study measurements.
fastsize came in the mail yesterday..not supposed to use it until after the study is done...

are there any out here on the forum who would care to relate their results so far in this study?

ohjb1

also completed Xiaflex trials and my curvature improved 5 degrees.  In my opinion, these rather minor degree changes are nothing more than measurement variations and represent no change.    

bones54

i agree that 5 degrees is within the range of examiner variability...but it somehow feels better to complain a litttle..javascript:void(0);

j

http://seekingalpha.com/article/135832-auxilium-pharmaceuticals-inc-q1-2009-earnings-call-transcript?source=yahoo&page=1

During this call, Auxilium's CEO talks about, and answers questins about, the status of Xiaflex for Peyronie's and the results of the recent phase IIb trials.  It's long and I've only skimmed it, but I noted these points:

1. This was just the IIb trial. The phase III trial wouldn't even start until next year.  

2. The amount of improvement that needs to be shown seems to be sort of up to the FDA.

3. From this trial they learned that their injection protocol probably wasn't optimal; it would be more effective if the injections were spread out.

4.  They're trying to decide whether 'modeling' (stretching) would improve the results.

5.  They're focusing on 'patient reported outcomes', rather than objective measurement of angulation, as success criteria.

6.  At this point there's a fair amount of corporate-speak and weasel-wording in response to the question of whether phase IIb was successful.


As I said, I only skimmed it. On the whole I would say it's positive, they're moving forward, and looking at ways to improve the treatment.




newguy

QuoteINTRODUCTION: Transforming growth factor-beta1 (TGF-beta1) has been known to play a crucial role in the pathogenesis of Peyronie's disease (Peyronies Disease). AIM: The aim of this paper was to investigate the therapeutic effect of IN-1130, a novel small molecule inhibitor of activin receptor-like kinase (ALK)5, a type I receptor of TGF-beta, in an animal model of Peyronies Disease. METHODS: Peyronies Disease was induced in rats through repeated injections of adenovirus expressing TGF-beta1 (days 0, 3, and 6; 1 x 10(10) particles/0.1 mL, respectively) into the tunica albuginea. The rats were divided into five groups (N = 10 per group): group 1, age-matched controls without treatment; group 2, age-matched controls receiving repeated injections of IN-1130 (days 30 and 37; 5 mg/kg in 0.1 mL saline, respectively); group 3, Peyronies Disease rats without treatment; group 4, Peyronies Disease rats receiving repeated injections of saline (days 30 and 37; 0.1 mL, respectively); group 5, Peyronies Disease rats receiving repeated injections of IN-1130 (days 30 and 37; 5 mg/kg in 0.1 mL saline, respectively) into the lesion. MAIN OUTCOME MEASURES: Penile curvature was evaluated by use of an artificial erection test at day 45, and the penis was then harvested for histologic examination. Collagen in the plaque was quantitatively assessed by hydroxyproline determination. RESULTS: IN-1130 induced significant regression of fibrotic plaque through reduced infiltration of inflammatory cells, reduced transnuclear expression of phospho-Smad2/phospho-Smad3, reduced hydroxyproline content, and reduced cartilage content and restoration of elastin fibers in the fibrotic plaque of Peyronies Disease rats, which was accompanied by the correction of penile curvature. CONCLUSION: Antagonizing TGF-beta signaling through the use of ALK5 inhibitors may represent an exciting new therapeutic strategy for the future treatment of Peyronies Disease.
- http://www.ncbi.nlm.nih.gov/pubmed/19473283?ordinalpos=1&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DefaultReportPanel.Pubmed_RVDocSum


It's not being used in humans yet, but is surely potentially promising for early stage peyronies. My core concern with all of these injectables in animal studies (which may not respond the same ways in humans anyway), is that during studies it's impossible to take into account any inherent suseptability to developing these conditions. It may be the case that injectables designed to treat these conditions are rather unfortunately least effective in people suffering from peyronies because these are the very same people who may have an exaggerated response to any damage done to the penis. That said if it can be shown that more good is done than harm that's all that matters.

I'm not as hopeful about Xiaflex as I once was because we're heard mixed coments, but maybe if they adjust the injection schedule and add traction is will me more effective. I'm jumping the gun a bit I suppose. When are we due to next hear from the company?

George999

When reading negative reports on Xiaflex and Alagebrium, one has to remember that both of these have been funded on a shoe string and are quite honestly only proof of concept treatments.  In both cases there are far more advanced variants in the pipeline along with new approaches as pointed out by newguy in the previous post.  We are still a long way off from a quick fix, but vastly improved treatments are on the way.  - George

j

George999, I don't completely agree with your assessment of Xiaflex.  

It has now been shown to work quite well for Dupuytren's contracture and is well beyond the proof of concept stage - it should be in wide use for Dupuytren's within a couple of years at most.  

For the last few years, Auxilium seems to have funded it adequately (before that it's another story).

With Peyronie's, results so far are marginal, but  "proof of concept" is a bit harsh I think.  They need to refine their treatment protocol considerably, but the "concept" seems pretty solid.


George999

J,  I fully agree that the concept is solid.  By "proof of concept", I mean just that, that Xiaflex has proven the concept viable.  And following Xiaflex, I believe we will see more and better treatments that follow the same approach.  I am not negative at all about Xiaflex.  But I try to be realistic in its capabilities.  I believe they will be shown to be limited and we will still need multiple treatment modalities to control Peyronie's, and note I use the term control as opposed to cure which I believe we will not see in the near future although we will likely come close.  - George

RichB

A question that puzzles me often is that most, if not all, of these treatments are for people in the early stages. If this is true, then why even bother looking at any of these treatments if you've had the condition for longer than a year or two? Not trying to be negative, it's just a thought.

newguy

RichB - I see there as being various stages for positive intervention by treatment:

1) Immediately following injury to the penis  (if the person is aware that an injury has taken place)  (Oral meds - esp Vit D, Pentox, NSAIDS - possibly surgery if a fracture occured during intercourse)
2) In the weeks/months/(years) that pain and plague is present/developing/resolving  (oral and mechanical aids - traction, ved - maybe verapamil injections)
3) If/When the condition has stabilised (oral treatments, but possibly emphasis on mechanical aids)

3 continued) Following a bout of peyronies (assuming that it does stabalise somewhat), a maintenance stage of oral (various) and mechanical (VED, traction) treatments can be used to attempt to simultaneously aid the current condition, and help ensure that the body is better able to deal with any reoccurences of inflammation and/or fibrosis which may come about due to new injury (as many of us are likely more susceptible to these inflammatory cascades than most of the male population).

In this system, I see the use of xiaflex as being a stage 3 treatment and as such it can potentially be of use to guys long after their peyronies has occured, as long as their condiiton hasn't calcified. Assuming that it does become a recognised treatment for peyronie's its use could possibly be significantly enhanced by those simultaneously taking various oral medications and using techniques which stretch the penis in some way and impede inflammation and fibrosis.

As for why to concentrate on treatments that may or may not be suitable for  any particular person, I think that comes down to the community aspect. We all know how horrible it can be to suffer from this condition, so it an early stage treatment emerges which is useful, it's in a sense our responsibility to hightlight it and let people know that it could be the right treatment for them.


LWillisjr

Quote from: RichB on June 15, 2009, 12:13:22 AM
A question that puzzles me often is that most, if not all, of these treatments are for people in the early stages. If this is true, then why even bother looking at any of these treatments if you've had the condition for longer than a year or two? Not trying to be negative, it's just a thought.

RichB,
Good point. Peyronies can be very different in it's symptoms and the way that it attacks each of us. So we need to be careful about suggesting or recommending the same treatments and time for everyone. For some who have Peyronies and deal primarily with pain, then they could go for years on oral meds for example to help keep the pain under control. For others, there is documented accounts of being able to keep the plaque in check with periodic flare ups. Again prolonged use of oral meds and VED/traction techniques may help and provide a reasonable remedy.

And then there are those like myself who definitely had plaque and in my case was causing an extreme deformity. A sharp curve of 70 degrees. I progressed through the classic textbook phases of initial stages, acute development, and then stabilization. And after 18 months the plaque was beginning to calcify. For people in this situation I agree that I don't see that continued usage of oral meds or therapies would do any good.  I had already tried most of these and nothing helped.

The curve was acute, intercourse almost impossible (at least painful for my wife), and traditional approaches didn't help. I think men in this situation have got to face the fact that they must evaluate the risks of surgery at this point.  I don't see any other cure coming in the near term. Some are waiting for the results of Xiaflex but I don't think it will be any better than Verapamil. It may work for some but won't be the silver bullet that helps everyone.

So we get to the point of "do we live with what we have been dealt with?", or do we evaluate the risks of surgery. Each must make their own decisions.
Developed peyronies 2007 - 70 degree dorsal curve
Traction/MEDs/Injections/Surgery 2008 16 years Peyronies free now
My History

j

I think Xiaflex will eventually be much more effective than Verapamil.  In fact I don't think verapamil works at all, despite claims to the contrary.   My guess is that Xiaflex injections will be combined with agressive "remodeling" - i.e. stretching - and that this treatment will make a big difference for a lot of guys. If you have an acute, localized bend that might actually be a good indication for Xiaflex therapy because it presents a well-defined target.  

ocelot556

Lwillisjr:

I don't think that calcification makes surgery a necessity. In this day and age, pentox has a good chance of staving off that process and there are always other medications coming down the pike. A quick search even uncovered drug trials being conducted today that are effective in reversing muscle calcification!

http://www.ingentaconnect.com/content/bsc/apl/2006/00000009/00000003/art00021

"Abstract:

A 25-year-old female patient with documented diagnosis of polymyositis developed extensive muscle calcification in the left thigh muscles with overlying skin induration one year after her disease onset, despite well controlled myositis. Plain X-ray of the left femur and hip revealed extensive calcification involving the periarticular soft tissue shadows around the left hip and left upper thigh. The patient received diltiazem 90 mg/day in divided doses and follow-up plain X-ray study after 6 months of treatment revealed almost complete resolution of the muscle calcifications."

MUSICMAN

As we wait for a medical drug cure time is passing us by. Xiaflex for Dupuytrens Contracture was in phase II in 2002 and they are hoping for FDA approval close to the end of this year. Xiaflex for Peyronie's  will not start a trial in phase III until mid 2010. How long to get FDA approval for Peyronie's is up to your guess. If approved for Dupuytrens a person might find a doctor to use it off label, but I  think it would be very pricey .
If you are a young man time is on your side. If your curve is slight you can still function. If your condition arrived at the average of 50 to 60 years of age and your bend is extreme then as I said time is running out.
I have been told "so what if you can not have sex, there is more to life than that! Easy to say to a man that can not walk as you run by him.

RichB

It seems to me like drugs that improve blood flow are crucial to preventing any kind of fibrosis. Has that drug been used to treat peyronie's patients before?

Here, I did a quick google search and came up with this. I have never seen this posted before: http://www.freepatentsonline.com/y2001/0047037.html

In section C:

"[0113] Whatever the mechanism, the present medicament shows an astonishing efficacy, particularly considering the miserable failure of such closely related prior attempts at Peyronie's disease treatment. One patient involved in experimental evaluation of the present medicament exhibited a penile curvature in excess of 75 degrees—a condition which was both painful and which effectively rendered the individual completely sexually dysfunctional. After using the medicament of the present invention, in the prescribed manner, this patient's Peyronie's disease symptoms were completely reversed in two week's time. Other experimental patients, albeit with less severe symptoms, have shown equally remarkable and complete recoveries, including one patient who suffered from Peyronie's disease for over sixty years, never having previously experienced success with any prior treatment regimen undertaken by numerous physicians."

What? This is, as I can see, just topical verapamil. It is dated from 1999.  

newguy

RichB - That's the problem with so many studies. They don't appear to pertain to reality.

LWillisjr

Quote from: ocelot556 on June 16, 2009, 02:37:33 PM
Lwillisjr:

I don't think that calcification makes surgery a necessity. In this day and age, pentox has a good chance of staving off that process and there are always other medications coming down the pike. A quick search even uncovered drug trials being conducted today that are effective in reversing muscle calcification!

Ocelot,
You are making the assumption that muscle calcification and plaque calcification are the same. And maybe they are. I'm not trying to be negative. But there are guys that have been waiting for years for "The Cure". And if you have calcified Peyronies plaque and don't have a severe bend, then maybe hoping for a near term cure is OK. My only point is that for those who have severe bends resulting in nearly imposible sex, and calcified plaque, you had better give surgery a hard consideration.

I can state for a fact a direct quote from Dr. Levine. He is the one that told me directly that once calcification sets in, that surgery is the last option available today.
Developed peyronies 2007 - 70 degree dorsal curve
Traction/MEDs/Injections/Surgery 2008 16 years Peyronies free now
My History

j

RichB, Jerry Easterling's "topical" verapamil treatement has, in my opinion, been thorougly descredited several times over.  

newguy

Talked about in the past I know, but a few new studies here:

29th April 2009
Quote1. Pirfenidone (PFD; 5-methyl-1-phenyl-2(1H)-pyridone) is an effective and novel agent with anti-fibrotic and anti-inflammatory properties. We investigated the anti-fibrotic effects of PFD on experimental liver fibrosis models in rodents, and its possible molecular mechanisms. 2. Liver fibrosis was induced by carbon tetrachloride (CCl(4)) in Balb/c mice. PFD (250 mg/kg) and silymarin (50 mg/kg) were given to different groups by gastric gavage for 4 weeks. PFD significantly attenuated fibrosis severity by 49.8% and 44.9%, respectively, measured through histopathological scores and hydroxyproline levels in liver tissue. Its anti-fibrotic effects were significantly higher than in silymarin-treated groups. 3. Liver fibrosis was induced by albumin antigen-antibody complex in Wistar rats, and the same dose of PFD and silymarin were given for 8 weeks. PFD significantly reduced fibrosis degree by 45.0% and 51.0%. Its anti-fibrotic effects were comparable with silymarin-treated group. 4. Effects of PFD on expression of extracellular matrix (ECM)-associated genes in human hepatic stellate cells (LX-2 cell line) were measured by real-time quantitative PCR. It significantly inhibited expression of smooth muscle alpha-actin (alpha-SMA) and type-I collagen in activated LX-2 cells in a dose-dependent manner. 5. PFD was effective in ameliorating fibrogenesis induced by CCl(4) in mice and by albumin-complex in rats. This was mainly mediated through its anti-activation and anti-fibrogenesis effects on hepatic stellate cells.
- http://www.ncbi.nlm.nih.gov/pubmed/19413596?ordinalpos=1&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DefaultReportPanel.Pubmed_RVDocSum

March 5 2009
QuotePurpose: To investigate the role of pirfenidone, a novel antifibrotic agent, on proliferation, migration, and collagen contraction of human Tenon's fibroblasts (HTFs). Methods: After treatment of HTFs with pirfenidone, cell proliferation was measured by MTT assay. Cell migration was investigated by Scratch assay. Contractility was evaluated in fibroblast-populated collagen gels. Cell viability was determined by trypan blue exclusion assay. The expressions of TGF-beta1, -beta2, and -beta3 were estimated with RT-PCR, Western blot, and immunofluorescence analyses. Results: Pirfenidone induced significant inhibitions of HTFs proliferation, migration, and collagen contraction in a dose-dependent manner. After treatment with different concentrations of pirfenidone (0.15, 0.3, and 1mg/ml) for 24 and 72 hours, cell viability showed no difference between treatment and control groups. After 24 hours of treatment with pirfenidone, HTFs showed decreased mRNA and protein levels of TGF-beta1, -beta2, and -beta3 with a dose-dependent manner. Conclusions: These findings indicate that pirfenidone inhibits proliferation, migration and collagen contraction of HTFs at nontoxic concentrations. Decrease in autocrine TGF-betas signaling may have roles in the effects of pirfenidone.
- http://www.ncbi.nlm.nih.gov/pubmed/19264889?ordinalpos=3&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DefaultReportPanel.Pubmed_RVDocSum

newguy

QuoteScienceDaily (May 17, 2009) — A large, well-controlled, multi-national clinical trial program has demonstrated the effectiveness and safety of what may become the first FDA-approved medicine for idiopathic pulmonary fibrosis, or IPF.

In a Phase III clinical study program called "CAPACITY," investigators discovered that the oral anti-fibrotic and anti-inflammatory agent, pirfenidone, could slow the deterioration of lung capacity in patients suffering from IPF.

The researchers presented their findings on Sunday, May 17, at the American Thoracic Society's 105th International Conference in San Diego.

The CAPACITY trial consisted of two multi-national, randomized, double-blind, placebo-controlled Phase III trials (CAPACITY 1 and CAPACITY 2) designed to evaluate the safety and efficacy of pirfenidone in IPF patients with mild to moderate impairment in lung function. The primary endpoint of change in percent predicted forced vital capacity (FVC) at week 72 was met with statistical significance in CAPACITY 2 (p=0.001), along with the secondary endpoints of categorical change in FVC and progression-free survival (PFS), defined as time to either death, a 10-percent decrease in FVC or a 15-percent decrease in DLCO (diffusing capacity of the lung for carbon monoxide). The primary endpoint was not met in CAPACITY 1 (p=0.501), but evidence of a pirfenidone treatment effect on the primary endpoint was observed at several periods in that trial. Importantly, greater than 80 percent of patients in the trials completed treatment and greater than 90 percent completed the study.

An exploratory analysis of pooled data from both trials revealed that treatment with pirfenidone resulted in a 30-percent relative reduction in the percentage of patients who experienced an absolute decline in percent predicted FVC of at least 10 percent. This magnitude of decline is considered clinically meaningful, as a 10-percent decline in percent predicted FVC has been shown in multiple studies to be an independent predictor of mortality in patients with IPF. Exploratory analyses of pooled data from the two CAPACITY studies also demonstrated a statistically significant treatment effect on the primary endpoint of change in percent-predicted FVC at week 72, progression-free survival time and change in six-minute walk test distance.

"While it was disappointing that the primary endpoint was not met in CAPACITY 1, important consistencies between the two CAPACITY studies were observed in the overall treatment effect of pirfenidone," said Paul Noble, M.D., co-chair of the CAPACITY program and professor of medicine and chief of Pulmonary, Allergy and Critical Care Medicine at Duke University Medical Center. "The treatment effect observed in the CAPACITY studies was generally consistent with that observed in the Phase III study in IPF patients conducted by Shionogi in Japan. Collectively, these three studies give us a very good sense of the impact that pirfenidone has on the progression of IPF over at least one year."

According to the National Heart, Lung, and Blood Institute, about 200,000 Americans have idiopathic pulmonary fibrosis, a condition that scars tissue deep in the lungs. Most patients are diagnosed with the disease in their 50s and 60s, and many people live only three to five years after being diagnosed. There are no approved medications in the United States or Europe to treat the disease. Pirfenidone is approved in Japan for the treatment of IPF.

A total of 779 patients were enrolled in the CAPACITY trials at 110 sites in 11 countries. The mean age of participants was 66. To be eligible for the study, patients had to have a definitive diagnosis made by high-resolution CT scan or by biopsy, and a FVC ≥ 50 percent of predicted values and a DLCO ≥ 35 percent of predicted value.

Dr. Roland du Bois, M.D., professor of medicine at National Jewish Health, in Denver, Colo., and CAPACITY co-chair, concurred that these studies were very encouraging for IPF sufferers and added that "the safety and tolerability of pirfenidone was reassuring. The principal side effects experienced by patients in the studies were gastrointestinal discomfort and photo-sensitivity, both of which were manageable in the majority of patients."

The CAPACITY trials follow a Phase III clinical study conducted in Japan that was reported at the American Thoracic Society's 2008 International Conference in Toronto. That trial, which demonstrated the ability of pirfenidone to reduce the decline of lung capacity and improve progression-free survival, served as the basis for the Japanese regulatory authorities' approval of the medicine for the treatment of IPF in Japan.
- http://www.sciencedaily.com/releases/2009/05/090517143231.htm

I suspect that if/when its approved by the FDA, it will be more readily available, and only a matter of time before somebody uses it for peyronies.

j

The  claimed result is "a 30-percent relative reduction in the percentage of patients who experienced an absolute decline in percent predicted FVC of at least 10 percent."  Sounds pretty weak.



 

newguy

j - Yes, that did occur to me when I made the last post. It could well be enough case on "works wonderfully in rats, but not well in humans". Still, some improvement is better than none, and used alongside other oral treatments this could potentially amplify its effectiveness. Maybe in those with long term peyronie's (most of us here) it may be of limited effectiveness, but for those new to the condition, maybe it could tip the balance.


ocelot556

lwillis --

Levine is very cutting edge as far as doctors go, but like most doctors related to Peyronies Disease they're not as clued-in to drug studies as we are. Levine for a long time held doubts that the VED would be of use, but after patients sent him photos and reports of progress with the VED, he began a study and became one of the prominent proponents of it's use.

I don't know if muscle and plaque calcification are similar, but Pentox's use was initially for claudication - it just so happens that making the red blood cells more squamous happens to force them into hard-to-reach places like fibrotic plaques better. My uro has me on a topical ointment that counts EDTA as an ingredient. EDTA is a chelating agent, used to remove heavy metals/calcium buildup. Xiaflex aside, medicines aren't being targetted to our condition - so we have to grasp at straws with drugs like Pirfenidone, Trazodone and others, formulated to treat more serious diseases but with the capacity to help ours.

You're absolutely right, however, on the last point. I'm speaking from my own position (many plaques but very slight bend, with ED). If one has a bend that makes sex impossible, I'd concur with yourself and Dr. Levine. But surgery, especially penile prosthesis, is a permanent solution to what in 10-20 years might be a temporary problem. They'll have a cure for Peyronies Disease before they have the ability to successfully attach a new biological penis, or restore what's been done in the Nesbit.

jackp

Quote from: ocelot556 on June 17, 2009, 04:32:06 PM
You're absolutely right, however, on the last point. I'm speaking from my own position (many plaques but very slight bend, with ED). If one has a bend that makes sex impossible, I'd concur with yourself and Dr. Levine. But surgery, especially penile prosthesis, is a permanent solution to what in 10-20 years might be a temporary problem. They'll have a cure for Peyronies Disease before they have the ability to successfully attach a new biological penis, or restore what's been done in the Nesbit.

You probably have not lived with peyronies and all the other side effects like many of us.

There is such a thing as quality of life. I have been living with this for almost 15 years. For the last 4 the quality of my sex life was not acceptable. I tried every thing legal, and some not, to improve. At 66 I did not have the option of waiting 10-20 years.

The only way I could get the quality of my sex life back to near normal was a penile prosthesis. Now at 8 months post op I have a better sex life than a lot of 20 year olds.

Surgery is an option of last resort. But when done by doctors like Dr. Milam, Dr. Levine and Dr. Lue that option will make you "normal again"

Jackp

Edited to fix Quote -
Hawk

ocelot556

Sorry if I offended you, jackp, but I don't come to this forum and engage in discussion because I enjoy the company. I have been suffering from peyronies and the side effects for three years now. It's not as long as most here, but I know full well how it affects one's quality of life.

The purpose of my post wasn't to deride anyone who has it worse than I do. I'm happy that some of us have found happiness and functionality with surgery. I was simply suggesting that with the rapid advancement in biotechnology and pharmaceuticals, younger sufferers might do better to live with that reduced quality of life and try to exhaust every non-invasive treatment first, as you did. Obviously age and severity of the disease is a consideration, but we're in total agreement about it being a last resort. When I see drugs in studies that suggest they might help even calcified plaques and all the other things that would otherwise necessitate surgery, that last resort doesn't seem so final.

If I had a necrotic limb, and I cut it off tomorrow, and two days from now they cured gangrene - they still wouldn't have the technology to grow my arm back.

George999

I really believe that surgery is the last option and has to be weighed very carefully by the patient since it is irreversible.  HOWEVER, this is an agonizing decision that must be made by the patient with the counsel of his doctor.  While we should encourage caution in this regard, we also should understand that each person's situation is different and what is right for one is not necessarily right for another.  We should also all be thankful that if surgery is needed, there are docs out there who can do a darn good job at it.  So I as much as I am expecting near term breakthroughs with systemic treatments, I am also delighted when guys come back here and report that they got fed up with waiting and opted for a surgical fix and are thrilled with the results.  These guys may not have a new penis, but at least now they have a fully functional one and are no longer consigned to the "waiting room" not knowing whether or not the doctor will ever be "in" for them.  We need to support both approaches here and provide the best information we can as guys struggle to make these difficult choices.  - George

jackp

Quote from: ocelot556 on June 17, 2009, 07:56:50 PM
If I had a necrotic limb, and I cut it off tomorrow, and two days from now they cured gangrene - they still wouldn't have the technology to grow my arm back.

You do not have a clue on what a penile prosthesis is. I look normal, feel normal and have normal sex. If you saw me in a locker room you could not tell I have a prosthesis.

All a penile prosthesis does is replace the spongy tissue in the corpora's with chambers that inflate and deflate. Nothing else in the penis is disturbed. If ever the technology you suggest is developed it is easily removed.

Georeg999

I read your post with great interest. If anyone ever finds the "magic bullet" I believe you will be the one. Thanks for the post I agree whole heartily.

Jackp

Edited to fix Quote
Hawk


Hawk

Interesting discussion.  As I read it some advocate waiting for a "cure" even if all current non-evasive treatments have failed.  The thought is that the silver bullet is bound to come sooner or LATER and surgery cannot be undone.

All of this is speculation based on:
The hope that the cure will come in this generation
The speculation that surgery will not be able to be undone in this generation.
The concept that someone with successful surgery even wants it to be undone
Disregard for the years of active sex life made available in the meantime with surgery.

I question the legitimacy of any of these arguments much less all of them in one single sweep.  If you are wrong an any one of them then surgery is an attractive option after current non-evasive methods fail.

Flipside:  What if you wait (unable to have intercourse) for 30 years for the cure that does or does not come, only to realize that with a prosthesis you could have had 30 years of normal intercourse and that tissue regeneration can replace penile tissue if you ever decide you don't prefer the surgical results.  All this is very possible since they can CURRENTLY strip all the cavernosal tissue from the penis of a rabbit and regenerate a fully functional organ.  Tissue regeneration is not science fiction.  The advances are astounding and my guess is it is as likely to be available for human use as quickly as a silver bullet in the form of an oral med. used to cure Peyronies Disease.  Clearly I have no way of knowing that but no one has any way of knowing the opposite.
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

LWillisjr

Guys,
I find this discussion fascinating. Is everyone assuming that surgery results in a prosthesis? I we all know that jackp is thrilled with his. And I would have gotten one if necessary. But you need to understand all the surgical options.

I don't want mine undone regardless of what discoveries are made in the next [fill in the blank]. My plaque was removed and simply a graft put in its place. My penis looks normal, feels normal, I get straight erections, and I achieve orgasm through various forms of stimulation and sexual positions.

Did I take a risk to get this? yes, as I felt the odds were in my favor.

WHY WOULD I WANT THIS UNDONE ?!?!?!
Developed peyronies 2007 - 70 degree dorsal curve
Traction/MEDs/Injections/Surgery 2008 16 years Peyronies free now
My History

George999

I think the point about surgery being irreversible has more to do with failed surgeries.  Some surgeries do fail you know.  And in the case of a failed surgery, the person can be left in a worse state than where they started from.  Are there inherent risks to waiting for a non-surgical cure?  Of course!  But there are also risks when taking the surgical option.  And there are cases when even a second surgery can't fix a surgery gone wrong.  And then were back in the same old boat of waiting for new medical technology that may not come in our lifetime, and worse off to boot.  ALL of these things have to be considered when making that decision.  As with a lot of other aspects of this disease, there is NO slam dunk.  - George

newguy

Quote from: lwillisjr on June 17, 2009, 10:21:29 PM


WHY WOULD I WANT THIS UNDONE ?!?!?!


Good point. Many peyronies disease sufferers would envy your position (since your surgery was successful). I certainly believe that in some cases surgery is a viable option. It all depends on the individual I guess, weighing up the risks, potential for future improvement and so on.  

ocelot556

Wow, I had no idea how much of a nerve I'd hit with some of the posters on this board.

A few things about my argument that are seemingly getting lost in the discussion: I explicitly mentioned younger sufferers. I don't think anyone would tell a 60 year old man to wait for a better treatment, if that treatment wasn't immediately in the pipeline. I also didn't say not to get surgery, I suggested that one take MORE time with non-invasive treatments. We know the study that suggest Pentox works better at month 6 than month 1, better still after years 1 and 2. I'm not saying one should wait 30 years, but is 2 years too long to wait? What's the exact cutoff in years between exhausting the non-surgical options and 'wasting your time hoping for a silver bullet'?

So using the logic that's followed me being told I have no clue, that my ideas are illegitimate AND that I don't have peyronie's or its symptoms -- why don't we ALL stop posting here, stop reading abstracts, lock up our VEDs, stop wasting money on meds and supplements and just go under the knife?

I'll answer for myself. I don't want to lose size with grafting or Nesbit procedures. I'd rather have a Colt .45 that has trouble firing than a Derringer that shoots every time. If it came down to getting a prosthesis, I'm still not sure I'd be able to do it - it might look and feel normal, but it wouldn't seem normal to me. I've read that you can feel it when it's not hard, too, like a weight, and if you get it at a young age you might have to get further surgery to get it replaced in 10-15 years, or to deal with infection.

I'm not trying to scare anyone away from surgery. I don't have a horse in the race. Do with your penis what you will.

Edit note: First post came off a little resentful at people "dissing the poster, not the post", and was too rhetorical.

jackisback

Ocelot,

My understanding of surgery is that it's not really a good option for those with ED, but really mainly only for those without ED, who just have too great a curve for comfortable sex (I'm talking about the less scary non-prosthesis procedure). If I'm wrong, someone please correct.  The second thing is that the smaller the degree of your curvature, the less you lose from Nesbit surgery. I'm in the same situation as you (ED, misfires, very slight curve, young) and personally I'd be thrilled IF there were a relatively safe surgical way I could sacrifice the centimeters necessary to straighten me out AND it completely restored erectile function to the way I used to be. Hell, I'd even sacrifice the same amount in girth if it were possible!

ComeBacKid

See J and I's report on topical verapamil, in my opinion that product doesnt work and was an utter failure!  I can't count the nights I spent letting the gel "sink in" on my penis while it caused extreme itching and irritation on my testicles, inner thighs, and penis as it spread around when I had boxers and clothing on after applying it.  I spent a good sum of cash on the junk and it was a waste!

Comebackid

Hawk

Quote from: ocelot556 on June 18, 2009, 12:21:22 AM
Wow, I had no idea how much of a nerve I'd hit with some of the posters on this board.

Ocelot, I didn't see much to suggest you hit a nerve.  I saw that you made some comments that some disagree with or see differently, thus a discussion ensued.

For instance, in your last post you are still assuming loss of size is a major issue.  There are several types of surgery.  Some reduce size, some do not.  Some are actually reported to increase girth.  Consider that along with the fact the some guy that starts with 8 1/2 inches may not mind an 8" penis.  Someone starting with 4 " may have a different view IF we are discussing only surgeries that shorten the penis.  There simply are no blanket solutions.  You have to individualize some of your statements to YOUR specific personal preference for your specific set of circumstances.
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

LWillisjr

Quote from: ocelot556 on June 18, 2009, 12:21:22 AM
Wow, I had no idea how much of a nerve I'd hit with some of the posters on this board.

Ocelot556,
I think it has generated some good discussion. No offense taken. Your points are valid in that trying alternatives for a few years is reasonable. Surgery shouldn't even be considered unless alternatives have been tried. But to me it is not dependent of age. It was just as hard for me at the age of 52 as it would have been at the age of 22.

The bottom line fact is that surgery is scary. The morning of my surgery I was still second guessing myself. Clearly there are those who have been chasing "The Cure' for many more than just a couple of years. I think those of us who have had surgery feel that it is a more viable option than people think. And doesn't even always end up with loss of length. I know 2 guys who had surgery that did not lose any length. It certainly is an option worth evaluating. There just aren't many facts or data regarding surgery (either good or bad) that helps one feel like they are making an informed decision. I do have a copy of a study completed by Dr. Levine. This was a long term follow up of over 200 of his patients who had surgery (both Nesbit and grafting). I'll try to take some time and figure out how to get it posted here.
Developed peyronies 2007 - 70 degree dorsal curve
Traction/MEDs/Injections/Surgery 2008 16 years Peyronies free now
My History

newguy

Quotelwillisjr -I do have a copy of a study completed by Dr. Levine. This was a long term follow up of over 200 of his patients who had surgery (both Nesbit and grafting). I'll try to take some time and figure out how to get it posted here.


That would be enlightening. The attachment limit is 300kb, if the file is too big maybe zipping it will help. If not, then there are always file upload sites such as megaupload.com and rapidshare.com .  

alcohen

What is this???

http://www.curepeyronies.net/

I found this site about a year ago and signed up for their e-mail update list.  I recieved an e-mail today that the site had been updated.  After reading the information on it...it sounds promising..  Has anyone else heard of this?  

Cut and pasted from the website:

Quote"The most discouraging aspect of producing this website is the lack of any significant progress in the effective treatment of Peyronies Disease (Peyronies Disease).  This may be about to change with findings published by South Korean researchers in the Journal of Sexual Medicine 2009; 6:1284-1296.  In order to adequately discuss this article and its findings,  I have to define the following terms.

Transforming Growth Factor (TGF) - one of several proteins secreted by transformed cells that can timulate the growth of normal cells.  It is known to be up-regulated in Peyronies Disease and is responsible for the fibrotic scarring that leads to penile curvature.  For Peyronies Disease, a decrease in TGF is a positive development because it lead a reversal of the process that results in Peyronies Disease and symptoms such as scarring and penile curvature.

Collagen - is a fibrous protein and its over production results in decreased tissue elasticity.  A decrease of this substance is also a positive development.  

The South Korean Researchers were studying the effects of a novel transforming growth inhibitor known as IN-1130.  Laboratory rats were given repeated injections of TGF in the tunica albuginea section of the penis.  Forty-five days after injections, the untreated rats exhibited, scarring, fibrosis, loss of elasticity in the penile tissue and significant curvature. That is, they developed what is known in humans as Peyronies Disease.  One group of in the treatment group was given injections of IN-1130 at intervals of 30 and 37 days.  

Rats treated with IN-1130 showed a significant, but not complete regression of the fibrotic plaque, which resulted in restoration of elasticity and correction of the penile curvature.  The collagen content in the fibrotic plaque was significantly reduced to amounts comparable to the control rats.

Injections of IN-1130 did not significantly affect serum concentrations of pro inflammatory markers.  That is, there was no significant allergic response.

The researchers noted that in their opinion this was the first report showing that pharmacolgical intervention was potentially useful in the treatment of Peyronies Disease when given at the early, unstable and progressive stage of the disease.

Further studies are needed to address whether this intervention induces regression of fibrotic plaque and correction of penile curvature if administered at the chronic or stable phase of the disease.

What follows are charts based on the findings from the research paper.  Note that I couldn't reproduce some of the data in the charts with the absolute exact values as the researchers, but my values below are very close. For example, I couldn't tell if penile curvature in the control group was 5,6, or 7 degrees.   Also, for simplicity sake, I left out some data that were in the original research and printed in the journal article.  
                     
In this finding, IN-1130 essentially corrects penile curvature of rats who are in the early stages of Peyronies Disease.  Each bar depicts mean values for 6 animals per group. It is interesting to note that those rats with Peyronies who were treated with Saline solution developed an even more severe penile curvature.

IN-1130 reduces transforming growth factor expression. Each bar represents the mean values of 6 animals per group. The values are presented as a percentage of the total number of cells counted.   As noted earlier, over expression  of TGF is thought to result in  Peyronies symptoms and a decrease in the activity ameliorates the symptoms.


Wow! Where does one go to give these guys additional funding.  For a man with Peyronies this research article represents a potential breakthrough treatment. (And I emphasize the word potential because the research is in the early stages and has not been tested on humans).  These laboratory rats had only two treatments with IN-1130 and had a remarkable improvement.  Who knows what would have happened with additional treatment.  

Almost one-half of all human medical deaths are somehow related to scar tissue disorders.  This ubstance, IN-1130, has been tested on other scar tissue disease and has exhibited healing properties.  According to Kidney International, it suppresses renal fibrosis.  TGF plays a central role in the progression of renal fibrosis.  IN-1130 significantly  suppresses this progression.  It also may be a breakthrough treatment for prostate cancer.  According to the Journal of Urology, Volume 180, Issue 6, IN-1130 demonstrated an enhanced immune response to cancer cells and is a potential prostate cancer treatment.

I am trying to get additional information on this substance. Who owns it?  Is it in the public domain for does a private company have a patent on it?  Is there additional Peyronies Disease testing planned? Stay tuned."

The guy who runs the site seems to be someone who genuinely cares.  I corresponded with him via e-mail when I first discovered the site.  Thoughts?

PS: post formatted for quote box, spacing, and line length.
Hawk

Iceman

thought .....it will amount to zip - see xiaflex for example

Tim468

From Nature Biotechnology this week:

Pfizer swallows Wyeth, validates niche buster
Cormac Sheridan, Dublin


Introduction

In late January, Pfizer made the headlines with its purchase of Wyeth, of Madison, New Jersey, for $68 billion. Though the merger made the bigger splash, another Pfizer deal, unveiled in December, could have equally substantial repercussions for biotech. The partnering agreement for Xiaflex with Auxilium Pharmaceuticals may be axiomatic of the type of future deal that New York–based Pfizer, and the rest of the pharma field, hopes to ward off pending revenue loss.

With much of large pharma facing near-term patent expirations on key products, the pressure to quickly replace revenues remains intense. And pharma won't be very selective about the areas involved, one analyst noted. "They'll take anything, as long as it wiggles and it works," says Andrew Weiss, an analyst at Zurich-based Vontobel. That will include 'niche busters'—drugs that successfully target limited markets—in the hopes they will fill in the revenue gaps formed by the multibillion-dollar drugs going off patent. (See Box 1 below).

For Pfizer, the deal with Auxilium, of Malvern, Pennsylvania, seems to fit the niche-buster profile, though Xiaflex (clostridial collagenase for injection), a bacterial collagenase, might grow into something more. The deal with New York–based Pfizer, which includes an upfront payment of $75 million as well as regulatory and commercial milestones totaling $410 million, is noteworthy not only because of the niche indications involved but also because of its limited geographical scope. Auxilium retains North American rights to the product, while Pfizer has rights for the European Union plus 19 other European and Eurasian countries. "It might be unique from that perspective," says Eric Schmidt, senior biotech analyst at Cowen & Co. in New York. "Maybe it's a sign that the biotechnology industry has greater leverage over the US pharma industry than it used to. That can't be a bad thing."

Xiaflex, based on a combination of several subtypes of collagenase enzyme derived from the bacterium Clostridium histolyticum, has completed a phase 3 trial in Dupuytren's contracture, and a biologics license application (BLA) filing is expected imminently. It is also undergoing a phase 2b study in Peyronie's disease, with top-line data expected later this year. Each condition arises from a thickening of collagen fibers. Dupuytren's contracture affects the hand, and makes straightening and extending the fingers difficult. Peyronie's disease causes an upward curvature of the erect penis and can result in pain and impaired sexual function. In each condition, surgical rupture of the collagenous tissue has been the only treatment option.

Schmidt says the niches targeted in the alliance simply constitute business as usual. "Biotech has made a living out of taking exotic indications few have heard of in the past and turning them into cash machines," he says. And that's what Auxilium (and now Pfizer) expect to do here: "It looks like about 3% to 6% of the Caucasian population in the US and Europe have some form of Dupuytren's contracture," says Auxilium spokesman Will Sargent. And Auxilium estimates that about 475,000 men visit urologists in the US and Europe every year seeking treatment for Peyronie's disease. "Pfizer did its own market research, and it matched what we had done," he says.

Though Auxilium sees the product as an eventual blockbuster, that is up for debate, of course. Jon LeCroy, analyst at Natixis Bleichroeder in New York, remains unimpressed with the deal, saying that Xiaflex won't move "Pfizer's earnings at all."

But the Wyeth merger would, or at least would add sales. Through the buyout, Pfizer gets Wyeth's stable of approved drugs, though many of those are facing patent expiration, too. It also gets Wyeth's share of the behemoth biologic Enbrel (etanercept), which has no generic competition, as well as vaccines.

Though Pfizer's need to fill a revenue gap is the most acute among its peers—its lucrative Lipitor (atorvastatin) franchise, worth $12.4 billion in 2008, will start to unravel in 2010—plenty of companies are under similar pressure and need to make moves (Box 2). For example, the hypertension treatment drug Diovan (valsartan), marketed by Novartis, of Basel, Switzerland, which achieved $5.7 billion in sales in 2008, loses patent exclusivity in 2011. "They have a pipeline they can work on, but they have to make sure that it works out," says Weiss.

Perhaps there is a different way forward for pharma, beyond the buyouts and traditional licensing. Edward Stuart, cofounder of HS LifeSciences, of Zurich, is managing a new evergreen, early-stage investment fund called QureInvest. HS LifeSciences has developed a distinctive approach to developing companies, in which it actively avoids venture capital investment and seeks early-stage deals for its portfolio firms that will minimize drug development time and maximize patent-protected sales. Some pharmaceutical firms are open to the model, Stuart says, though successful partnering always takes long-term commitment and a sense of realism on both sides of the table. Big pharma companies have to deploy their power intelligently, while biotech needs to relinquish its traditional swagger. The whole industry must take a step back and re-examine.

It could happen. "Everybody is looking at it pragmatically at the moment," Stuart says.

[Box 1]

Niche medicines have had a good track record of late, featuring prominently in the tally of 25 new drugs and biologics that the US Food and Drug Administration approved last year. For example, two thrombopoietin receptor agonists gained approval for treating immune thrombocytopenic purpura: Nplate (romiplostim), developed by Amgen, of Thousand Oaks, California; and Promacta (eltrombopag), developed by GlaxoSmithKline and Ligand Pharmaceuticals, of San Diego, California. Cinryze, a plasma-derived human C1 inhibitor, gained approval for hereditary angioedema, which is also rare.

In some cases, ultra-niche indications (those with less than 1,000 patients) can lead in to mainstream areas with more commercial potential, says Andrew Weiss, pointing to the research of Mark Fishman, president of Novartis Institutes for BioMedical Research in Boston. His work on the genetically inherited autoimmune condition Muckle-Wells syndrome (MWS) yielded ACZ885 (canakinumab), an anti-interleukin-1 (IL-1) beta antibody. The product is undergoing regulatory review for MWS, but it also could have potential in rheumatoid arthritis, psoriasis, type 2 diabetes and other conditions. "From that point of view you may see more activity in ultra-niche indications," says Weiss.

Regeneron Pharmaceuticals, of Tarrytown, New York, is following a similar strategy. It gained approval in MWS and related cryopyrin-associated periodic syndromes last year for a fusion protein called Arcalyst (rilonacept), which blocks IL-1 beta by acting as a soluble decoy receptor. It is now testing the product in patients with gout.

Edward Stuart of HS LifeSciences is critical, however, of the increasing focus on specialty medicines, which he says misses the most significant contribution that biotech can make in medicine: bringing high levels of innovation to bear on major medical problems. The focus on specialty medicines, he says, is driven by the short-term concerns of venture capital funds. "They have systematically tried to beat the innovation out of companies and turn them into specialty pharma companies," he says. "There's nothing wrong with that, but they shouldn't dress it up as biotech."

[Box 2]

The Pfizer-Wyeth merger has some worried that a wave of consolidation may occur among large pharmaceutical firms, leaving cash-strapped biotech companies with fewer potential partners or buyers. The Pfizer-Wyeth merger already scuppered one deal: Wyeth's reported $1.35 billion bid for the vaccine maker Crucell, of Leiden, The Netherlands. But not all pharma firms are planning to take the mega-merger route. London-based GlaxoSmithKline CEO Andrew Witty and Basel, Switzerland–based Novartis CEO Daniel Vasella both recently ruled out such a move, saying they would continue to seek smaller transactions and diversification. AstraZeneca, of London, has said it doesn't need a merger to help itself.

It's not easy telling pharma's future anyway. Edward Stuart of HS LifeSciences points to the recent appointments of new CEOs at many of the top ten pharma companies—including Severin Schwan at Roche, which is attempting to buy Genentech (see p. 212). The fresh blood could affect the culture and the partnering behavior of the companies concerned, and it's hard to know in what direction they will pilot their ships. "These guys are the next generation," he says. "All of these guys are going to put their approaches to work in their [respective] companies." But the basic overall dynamic of big pharma–biotech partnering is unlikely to change dramatically. "I'm guessing it might be difficult to get the attention of the Wyeth business development people in the next couple of weeks. I don't think it's going to take them out of the game in terms of the deals they were looking at," says David King, who sold one of his ventures, the protein engineering firm BioRexis Pharmaceutical, of King of Prussia, Pennsylvania, to Pfizer in 2002.

To decide if the UK's NHS should pay for a drug, NICE assesses the treatment's additional cost over that of the current standard therapy, set against the extra health benefits it confers. The tool for comparing the value or health gain of different drugs is the quality-adjusted life year, or QALY, which, at its crudest, measures the increase in life expectancy and quality of life derived from any treatment.

The main difficulty with QALYs is that this measure does not take account the severity of the underlying condition. A second major problem is the question of who decides what is an acceptable cost per QALY. Any drug with a cost per QALY below £20,000 will automatically get the nod; those between £20,000 and £30,000 will need additional evidence; and it is rare for drugs with a cost per QALY of over £30,000 to be approved.

Given an unacceptable price per QALY, there are two ways forward for companies to get NICE's approval: provide more compelling data for benefits or lower the price. In Australia, negotiating price is an explicit part of the HTA process. Similarly, in France the clinical added value, as determined through an HTA, is the key factor in agreeing on a price.NM

52, Peyronies Disease for 30 years, upward curve and some new lesions.

newguy

alcohen - From the name I assumed that the curepeyronies website was one designed to extract money from desperate people via products which don't actually work. Upon actually visitng the site though, it appears that the guy has good intentions and is simply presenting info and looking towards the future for more useful treatments.

I have already posted about IN-1130 (http://www.ncbi.nlm.nih.gov/pubmed/19473283?ordinalpos=1&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DefaultReportPanel.Pubmed_RVDocSum). That study was promising, but I should point out that just because a study in rats is successful, it doesn't always follow that it will be useful to humans. There is of course a chance that it will though, so it will be interesting to hear more about IN-1130 in the future. The sooner the better.  

George999

It is important to be aware that new potential treatments are moving forward RIGHT NOW in trials around the world.  Here is just one example:

Quote from: Hadassah Blog

A Treatment to Swallow

Hadassah doctors, working with Harvard Medical School, are researching a groundbreaking liquid therapy to target and prevent autoimmune diseases. ... Thirty days later, the patients who follow these directions and swallow the liquid daily will find themselves free of their diabetes, lupus, multiple sclerosis, rheumatoid arthritis, Crohn's disease, ulcerative colitis or whichever of the more than 80 other distinct and crippling auto-immune illnesses dispatched them to their doctor. ... "At this stage, we don't even know whether our compound will be a treatment or a full cure," says Dr. Ilan. "But we're optimistic. We believe the trials will show that it has the capability to repair the basic defect that triggers the autoimmune disease process, and will thus be effective against the whole range of such illnesses. And this is a belief shared by several pharmaceutical multinationals, which show interest in investing in our project."


- George


Iceman


George999

Quote from: Iceman on July 01, 2009, 09:11:17 PM
so when will we be able to use this you think????

This one is "out there" a ways.  How long is anyone's guess.  I suggest you read the full article to get a better picture if you haven't already.  AND remember, this is just ONE of a number of very promising approaches.  The big thing to remember is that now many diseases are being lumped into one target, so that modifying one biological pathway will treat or cure multiple diseases.  This is VERY good for diseases like Peyronie's that otherwise would receive little attention.  And all of this is being accelerated by the power of the Internet to enhance communication, the rapid accumulation of knowledge and the power of computers to sift through it, AND the growing transformation of developing countries into developed countries with maturing medical research programs.  - George

ocelot556

Wow, George, that's an amazing find. Modern medicine is trying to "move up" in the command structure of the body, and it seems like this compound - if it works as advertised - will be doing just that.

Imagine, one teaspoon a day for a month and you can hit 'reset' on most major autoimmune disorders. It's good news for our affliction, but it's great news for people with MS, arthritis, and diabetes. Here's hoping it's all that little-known blog talks it up to be.

Ted Williams

Here is a little hope to share on the Xiaflex front.  My understanding is that it will be reviewed by the FDA on September.  I will definitely seek out a doctor willing to use it off-label a.s.a.p.  

http://video.aol.de/video-detail/frozen-finger-fix/446064678

This is a video of patients with Duprytens but they are reporting a 90% success rate in the trial group receiving Xiaflex.  

My belief is that for a consistent study, the doctors are told to make a direct injection into the plaque.  I have seen Dr. Levine perform the procedure with interlesional verapimil where he more aggressively moves the needle through the plaques to not only break them up, but to evenly distribute the verapimil throughout the plaque.  My belief is that a technique like this applied to Peyronie's with Xiaflex could enhance results for those receiving the treatment.  Add on top of this Pentox for any subsequent injection site issues and traction and our army of other treatments, and I believe success can be enhanced.

Food for thought.

j

Ted, thanks for the video link.  I have 2 bent fingers waiting for Xiaflex. I recently had a thumb straighted (partially) by a hand surgeon using the minimally invasive technique called needle aponeurotomy. Xiaflex injectinos should be quite a bit gentler than what I just went through for the thumb.

As can be seen in the video, this stuff works - on fingers.  Whether it will work on Peyronie's has yet to be seen, but as you point out, the key is probably going to be more sophisticated ways of injecting it.

Xiaflex has risks, though.  Since it literally dissolves collagen, and doesn't necessarily know "good" collagen from "bad", it has to be carefully targeted.

cowboyfood

Quote from: j on July 10, 2009, 09:50:08 PM

Xiaflex has risks, though.  Since it literally dissolves collagen, and doesn't necessarily know "good" collagen from "bad", it has to be carefully targeted.

J,

I saw the video also, and it looks and sounds like good news for your condition!

However, what's your basis for stating that Xiaflex doesn't necesarily know "good" collagen from "bad" collagen?

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

ComeBacKid

Ted,

The video says 80% success rate, not to be a debby downer, just didn't know if you missed that?  Either way thats pretty impressive to me. That lady looked pretty happy.  If that works on my penis my smile will be 10 times that much, don't want to get to fired up yet though.  I don't know if the damaged tissue is the same in the hand as in the penis.  One thing I noticed is they had 1,000 patients, thats a pretty big sample size....  

J,

I would think "bad" collagen is not longer collagen, but fibrotic tissue, thats more a more deeply wound spiderweb, perhaps the medicine can recgonize the difference.  That lady didn't appear to have any damange from it?

Comebackid