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

[ocelot556]

I might be beating a dead horse here, but does anyone know if there are interferon studies going on now? I've seen a few promising summaries about it's interaction with Peyronies Disease, but apart from the fact that Dr. House is always giving his patients interferon on TV, I don't know a single thing about it! It seems like this is a solution that encourages the production of collagenase in the body, and yet I don't know of anyone who's received it as a treatment. Anyone know anything about this?

[George999]

Synvista is continuing its work on Alagebrium which is apparently in Stage III trials.  This drug is the "only A.G.E. Crosslink Breaker in advanced human testing". I believe this drug holds great promise for Peyronie's patients:

Synvista's clinical program on treating diseases associated with aging and diabetes is focused on alagebrium, a first-in-class A.G.E. Crosslink Breaker. It has been demonstrated that the formation of A.G.E. Crosslinks is a process that results in irreversible tissue damage associated with enhanced inflammation, deposition of collagen, the major structural protein in the body, and a diminished function of many tissues and organs. Alagebrium is the most advanced agent in a new class of compounds thought to chemically "break" A.G.E. crosslinks, thereby restoring more normal function to organs and tissues that have lost flexibility or function as a result of the crosslinks or the consequent tissue alterations induced by inflammation and scarring. By cleaving the pathological bonds that cause tissues, organs and vessels to stiffen and lose function over time, alagebrium has demonstrated the ability to reverse certain age-related and diabetes-related conditions. A.G.E.s also are known to upregulate various inflammatory and matrix producing cytokines. These signaling molecules are known to modulate the body's response to injury and inflammation and are responsible for both healing and scarring of tissues. As a composite, these cytokines induce pathologic alterations in tissues and organs resulting in a loss of flexibility or function. The deposition of excess collagen matrix protein in the heart results in stiffness of the ventricles or pumping chambers of the heart leading to diastolic dysfunction and chronic heart failure. Similar deposition of matrix proteins in the kidney results in scarring of the kidney with leakage of protein into the urine. Similar alterations are known to occur in many organs including the eye, resulting in visual impairment that is provoked by aging or elevated glucose in diabetes.

Alagebrium efficacy data are consistent across species. Studies in animal models in numerous laboratories around the world have demonstrated rapid reversal of impaired cardiac, vascular, renal, and other systemic functions with alagebrium. Alagebrium is being evaluated in various pre-clinical models to assess its safety and potential in a number of other disease states, including atherosclerosis, vascular calcification, peritoneal dialysis, osteoarthritis, arterial remodeling, forensic DNA identification, ischemic induced neovascularization, effects on renal function in response to oxidative stress, glaucoma, acute macular degeneration, erectile dysfunction and Alzheimer's disease, among others.

Synvista R+D Pipeline

More information can be found in their February 2008 overview document:

Synvista February Overview (PDF Document)

Research on this product IS ONGOING globally and is uniformly PROMISING!

Advanced glycation end-products and arterial stiffness in hypertension. Mar 2007

This brief review discusses the formation of AGEs, their role in mediating cardiovascular injury, as well as the results of experimental and clinical studies involving alagebrium.

Cross-link breakers as a new therapeutic approach to cardiovascular disease. Nov 2007

We aimed to evaluate the role of AGEs on duodenal nNOS expression and the effects of aminoguanidine (a drug that prevents AGE formation) and ALT-711 (AGE cross-link breaker) in experimental diabetes.

Inhibitors of advanced glycation end-products prevent loss of enteric neuronal nitric oxide synthase in diabetic rats. Mar 2008

For those interested in further reading on the subject:

Background: Glycation and Crosslinking Proteins

[roadblock]

Wow...sounds too good to be true. One thing I didn't see, though, was much in the way of current, ongoing trials. Is it dead in the water? Surely with the broad spectrum of possible applications for this drug someone would pick up the ball and run with it?? At least we have Alagebrium and Xiaflex on the horizon to give us something to feel hopeful about!

Addendum: I take that back...looking a bit more closely at the info on their website it appears that they are going forth with two Phase 2 trials that should produce data by sometime in 2009. So, probably looking at 2012 or so?

[ocelot556]

http://en.wikipedia.org/wiki/Alagebrium

...It's wikipedia, sure, but it says here that the company that picked Alagebrium up isn't going to be developing the drug for economic/pharmaceutical reasons. I hope this isn't true - since the last line essentially conveys "This molecule is easy to replicate and therefore not cost-effective, therefore it will never be released!" or something. Maybe I'm misreading in a pessimistic way.

[George999]

I think it is helpful to look at their 10K which is a form that they must file with federal regulators and disclose.  Prepare to be blown away!

Alagebrium chloride or alagebrium (formerly ALT-711), is an Advanced Glycation End-product Crosslink Breaker being developed for diastolic heart failure ("DHF"). To date, alagebrium has demonstrated potential efficacy in two Phase 2 clinical trials in heart failure, as well as in animal models of heart failure, nephropathy, hypertension and erectile dysfunction ("ED"). The compound has been tested in approximately 1,000 patients, which represents a sizeable human safety database. Our goal is to develop alagebrium in DHF and nephropathy. These diseases represent a rapidly growing market of unmet medical needs, and are particularly common among diabetic patients. ... The data from one Phase 2 clinical study, presented at the American Heart Association ("AHA") meeting in November 2005, demonstrated the ability of alagebrium to improve overall cardiac function, including measures of diastolic and endothelial function. In this study, alagebrium also demonstrated the ability to significantly reduce left ventricular mass. In November 2007, a 100-patient, placebo-controlled, two-arm study called BENEFICIAL (Double-blind, placebo-controlled, randomized trial evaluating the efficacy and safety of alagebrium) began patient enrollment to evaluate the efficacy and safety of alagebrium in patients with chronic heart failure. We expect to report initial results from this study in the second quarter of 2009. ... In July 2006, we announced that the Juvenile Diabetes Research Foundation ("JDRF") awarded a research grant to one of our independent researchers, Mark Cooper, M.D., Ph.D., Professor at the Baker Heart Research Institute, Melbourne, Australia. This grant will fund a multinational Phase 2 clinical study of alagebrium on renal function in patients with type 1 diabetes and microalbuminuria. Alagebrium will be tested for its ability to reverse kidney damage caused by diabetes, and to reverse the protein excretion which is characteristic of diabetic nephropathy. Dr. Cooper has demonstrated promising preclinical results with alagebrium in diabetic kidney disease. We expect to enroll patients in this study beginning in the first quarter of 2009 and results may be available approximately 30 months following enrollment of the first patient. ... In addition to these pipeline products, we have identified compounds in multiple chemical classes of Glutathione Peroxidase Mimetics and A.G.E. Crosslink Breakers and A.G.E. Formation Inhibitors that may warrant further evaluation and potential development. ... A.G.E. Crosslink Breakers have the potential to treat a number of medical disorders where loss of flexibility or elasticity leads to a loss in function. Alagebrium has demonstrated the ability to reverse tissue damage and restore function to the cardiovascular system in Phase 2 clinical studies in cardiovascular distensibility and DHF. Additionally, we are evaluating the development of several compounds in the breaker class for other indications where A.G.E. crosslinking leads to abnormal function. ... We have identified several potential chemical classes of A.G.E. Crosslink Breakers, and have an extensive library of compounds. ...  The majority of our patents and patent applications are in the following three areas: there are 146 issued patents and 45 pending applications in the United States and world-wide, related to A.G.E. crosslink breakers.

Note that research IS ONGOING!  Also note that alternative non-profit funding sources are being tapped.  In addition note that they have more potential AGE related products in the wings.  The full 10K is posted here. There is plenty of information included which gives a much better picture than the brief and misleading Wikipedia entry.  This company is very much alive, active, and dedicated to delivering their product.  They currently have $26M on hand having spent $260+M since 1987 or so.  So far they have profited nothing.  But this is the nature of the industry.  They are continuing to raise the money and are continuing to move alagebrium through the necessary regulatory hopes.  They are not there yet but they are moving along, none the less.  These compounds are EXTREMELY promising and one way or another they will find their way into the market place.  So chill out!  - George

[George999]

If it can kill cancer, could the same methodology also knock out plaque?

(The Kanzius Machine)

[Tim468]

When I saw it on TV I thought the same thing. We have to identify a way to get the metallic compounds into the plaque, which is really touch material with low blood flow. It would require getting antibodies to attach to plaque specifically, and "flip" the "nano-bots" of metal into the cells. No easy task.

Tim

[George999]

For the doubters out there, here is even more evidence that SynVista is serious about Alagebrium chloride AGE-Breaker.

Current Trial (note the date!)

[tommarkey]

Hi everyone!

I was reading about the clinical development and trial of AA4500 (collagenase) of Auxilium labor (the last new)... Someone knows how is the progress of the trial? I read that AA4500 will be able in the market in 2008/2009... So, i think that they are having sucess in tratament (Can we have hope? )... And this forecast is to Europe, after this the USA, and someday here...
I don't have find any research about Peyronie... Really exists an interest
of the labors to find a cure?  

George: I didn't understand all about Algebrium.. It's just for ED or improve Peyronies to? (curvature and plaque)

[George999]

Whether it is ED or Peyronies, the root of the problem is tissue fibrosis.  In the case of Peyronies, it is fibrosis of the Tunica Albuginea.  In the case of ED, it is more likely to be Vascular Fibrosis.  Alagebrium treats both problems.  Its first use will likely be for Systolic Hypertension which is caused by Arterial Fibrosis.  Alagebrium Chloride is a drug that acts at the molecular level to treat virtually all forms of tissue fibrosis from Cataracts to Cirrhosis of the Liver and perhaps even Alzheimers.  It works by dissolving the abnormal molecular bonds at a systemic level.  It is a very promising substance that I believe has a great future.  Multiple Phase II trials have already been done and all have been successful.  - George

[MUSICMAN]

Like a man drowning in the ocean we will reach for a piece of straw to help us stay afloat. If this " Alagebrium Chloride" is great stuff I don't suppose a man
can stop at the local chemical supply house and pick some up. It's side effect
is probably worse than Peyronies ( if that is possible ). George how can I place
my order?

The thought crossed my mine about the drug testing.  If half of the men take
a "placebo" and the drug works, what about the poor B@@@ards that took the
empty bullets??   Do they get the real thing later?

If I sound a little irritated it is sometimes hard to live with a boomerang.

[George999]

Musicman, Its out there, but I certainly wouldn't recommend anyone buy it at this point.  The reason is that I am not sure that one could trust the supplier AND that it would be difficult to work out the right dosage.  I thoroughly understand your frustration, but there are some legit reasons why drugs are tested the way they are.  Anyone participating in a study who receives a placebo instead of a drug that later proves effective can have access to that drug just like anyone else when it is approved.  I have a lot of confidence in the effectiveness of this particular drug from what I have read and hopefully it gets approved for SOMETHING soon.  At that point the trick will be convincing our uros to prescribe it for an off-label use.  On the other hand, some innovative uro like Dr. Lue could pick up on it and make it available on a quasi research basis.  Another important point is that this drug is just the first of a number of new drugs with the same mode of action that will be moving through clinical testing in the days ahead.  Anyone of them could end up being a (the first) really good Peyronies treatment.  Until then, the most effect treatment in my estimation is probably the VED.  It is certainly the only treatment that offers relatively quick results.  - George

[MUSICMAN]

George I follow your way of thinking very well but I am sure a man
that is dying of a disease wants a cure Right Now!  My thinking is that
if a person wastes 2 years on the placebo he is never going to make that
2 years back.  I am not getting any younger and sooner is better.
                                                             Musicman

[George999]

Synvista has announced that its Alagebrium trial is now underway with completion expected within the next 18 months or so:

Synvista Initiates Phase II Heart Failure Study
Synvista Therapeutics Announces Initiation of the BREAK Study of Alagebrium for Diastolic Heart Failure

[ocelot556]

George, you're the dogs bollocks as they say for keeping on top of these things. Thank you for your effort, it's always a glimmer of hope in what is generally a hopeless affair.

I've been doing a little reading into Synvista, as well, after following the links you previously put on this forum - and noticed that in some of the writeups of alagebrium it says that it only breaks one of two kinds of AGE fibrosis. I can't recall what the two types were, but do you think this is a potential cure? They certainly seem to discuss it that way vis a vie arterial plaque, but I can't be sure how much of that is hype versus the actual results.

Similarly, would the AGE breaker compounds really do that much for established plaque in the tunica? Obviously this is fledgling stuff and being employed for more life-threatening diseases, but the results in the ED reports are heartening. Wouldn't alagebrium also reverse a number of other problems in the body, like accumulating but-not-yet-dangerous artertial plaque, poor circulation, wrinkles, et al?

I'm surprised if (as they claim in a lot of the AGE breaker literature) most issues of aging are caused by glycation endproducts, that there isn't millions more in this research. Maybe I'm not grasping it, but it seems like this would be the "golden ticket" for any company, if it can reverse the byproducts of the aging process, specifically superficial ones like skin quality...

[George999]

I've been doing a little reading into Synvista, as well, after following the links you previously put on this forum - and noticed that in some of the writeups of alagebrium it says that it only breaks one of two kinds of AGE fibrosis.

There are two major types of AGEs.  Both (plus lesser types) can be inhibited by currently available products.  As of now, only one type can be broken by Alagebrium and other products in the drug pipeline.  The search is on for substances that can break the other major type at this point.  There is LOTS of work going into this behind the scenes by some major venture capital pharmaceutical organizations.

I can't recall what the two types were, but do you think this is a potential cure? They certainly seem to discuss it that way vis a vie arterial plaque, but I can't be sure how much of that is hype versus the actual results.

If you break half the crosslinks, you get a LOT of elasticity back.  Enough so that you wouldn't be worrying a lot about the other 50%.  So I am not sure I would use the word cure in the sense of ending up as pure as a baby.  But I suspect it will be a functional cure.

Similarly, would the AGE breaker compounds really do that much for established plaque in the tunica? Obviously this is fledgling stuff and being employed for more life-threatening diseases, but the results in the ED reports are heartening. Wouldn't alagebrium also reverse a number of other problems in the body, like accumulating but-not-yet-dangerous artertial plaque, poor circulation, wrinkles, et al?

That is the exciting part.  This new emerging class of drugs has the potential to positively impact the whole body.  And that is something that is being noted in the studies.  Participants are realizing that other things are getting fixed besides what this drug is targeted for.  But one thing you have to understand is that it is dependent on things like blood flow in terms of efficacy in clearing out AGEs.  The tunica has notoriously poor blood supply.  This means that once again we are looking at a long term project.  On the other hand, Synvista is targeting the Aorta simply because it has notoriously robust blood supply and can be repaired rather quickly.  So this is the fastest route to get this drug through the FDA.  From there, they should finally have a food chain to feed further research and approved uses.

I'm surprised if (as they claim in a lot of the AGE breaker literature) most issues of aging are caused by glycation endproducts, that there isn't millions more in this research. Maybe I'm not grasping it, but it seems like this would be the "golden ticket" for any company, if it can reverse the byproducts of the aging process, specifically superficial ones like skin quality...

At this point it is mostly venture capital companies.  Thats the way it ALWAYS is with new therapies.  But once it gets approved, watch for Synvista to get snapped up by one of the big guys.  There are two things at play here.  1) The big companies ALREADY have blockbuster products and they don't like to take risks on new approaches.  They prefer to build on and refine what they already have.  2) They view new approaches with some degree of fear and trepidation and are to some degree loathe to fund them.  After all, can you imagine what this would mean to a number of companies current product portfolios that DEPEND on the AGE process to generate customers?  So its really a two edged sword for them.  But once the cat is out of the bag, watch for one of the big guys to snap this up.  The choice is to be innovated out of business or to own the new killer product.  They will all be looking for a way to survive once this is out the door.  There will likely be a feeding frenzy of buyouts of all the little VC outfits that our making headway in this arena.  - George

[George999]

FRIDAY, May 23 (HealthDay News) -- Patients with a progressive fibrosis of the lungs that's fatal within a few years of diagnosis may finally have some reason for hope.

Japanese researchers say daily use of the drug pirfenidone improved the lung function and lengthened the survival of patients with the illness, called idiopathic pulmonary fibrosis (IPF).

Drug for Deadly Lung Disease Shows Promise

- George

[newguy]

I was diagnosed with Dupuytrens about 10 years ago and had a very successful palmar fasciectomy about 7 years ago. Nonetheless, the nodules and bands continued to develop in other parts of both hands. Two years ago, I started treatment in a clinical study of an investigational drug, pirfenidone - an anti-fibrotic which has been successful in treating pulmonary fibrosis. The purpose of my study was to investigate the drug for treatment of radiation-induced fibrosis. (I was treated with radiation and chemotherapy six years ago for throat cancer). The drug helped a lot with my swallowing but I also noted a distinct improvement in the Dupuytrens. It used to be painful for me to tightly grasp certain objects - no more. I saw my hand surgeon last week and he measured my range of motion in all fingers as at or within 2% of normal. On some fingers, the bands have disappeared and on others, they have significantly reduced. So, something is going on and I think it is the pirfenidone.

There were less than 10 people in my study and there are not that many people with pulmonary fibrosis so I might be the only person taking this drug who happened to also have Dupuytrens.

I have emailed the manufacturer of the drug to make sure that they know about my experience. I am not sure what to do next but I would like to get some organization to press the manufacturer to conduct a study of this drug on DC victims. BTW, the only side effect I experienced was some stomach upset which Prilosec counteracted and some fatigue during the first few months of the study.

Source:  http://www.biospecifics.com/DNForum/default.aspx?f=5&m=2104 - Post from way back in 2004 . I have no way of ascertaining it's validity, but it's very interesting and hold potential promise, no?

Edit - Just did a search and found that this had been posted here a couple of years back. Feel free to delete it if you wish.

[Old Man]

newguy:

If you will go to the Child Boards topic you will find a thread that contains quite a number of posts brought to this forum from the Biospecific forum when this one was started. It contains the "best posts" from the Biospecific forum made by bone fide people.

This forum resulted because the man who started it was totally fed up with the way that forum was run. That forum did not require registration, no I.D.s or passwords to join. It was a disaster so for all practical purposes it became useless.


Old Man

[George999]

It just gets better!  Here is yet another company developing anti-Glycation drugs:

Earlier in the company's history, Tobia was in a lab where the company was conducting animal studies related to 3DG and diabetes.

"I picked up one of the mice," she said. "Don't ask my why I did it, but right away I could feel the difference in the skin of the animal being treated. There was a measurable difference in the skin elasticity of the animals being given the drug and those who didn't get any."

Dynamis discovered 3DG causes inflammation, loss of collagen, disabling of collagen and other factors that contribute to skin aging.

Dynamis finds compounds that may slow aging process

- George

[Tim468]

Hi George,

I wrote a long piece on Pirfenidone a while back for those who are trying to understand it's mechanisms.

https://www.peyroniesforum.net/index.php/topic,35.msg6411.html#msg6411

The anecdotal evidence regarding DC is very interesting - and precisely how ideas promulgate. What is awful is how reports like this do NOT lead to clinical trials like they should.

Also, don't forget that Intermune had to be sued by sufferers of Indiopathic Pulmonary Fibrosis (IPF) to get the studies back up and running. I am not sure why the Japanese group ended up publishing first. It was interesting to learn that more people die of IPF than do from breast cancer every year, yet no-one seems to know anything about it.

Tim

[George999]

What is awful is how reports like this do NOT lead to clinical trials like they should.

Hmmm ... I wonder if it has something to do with $$$?

Lipoxysan is another promising treatment that has yet to get off the ground after nearly three years since promising trial results were reported.  I really suspect that the fact that the pharmaceutical execs are aware that these treatments against Glycation and its effects would severely compromise the performance some of their current star products has something to do with the decision to relegate these candidates to the round file as quietly as possible.  Maintenance drugs have a far superior profit profile as compared to curative treatments so it is not surprising that these companies tend to focus their R+D money on maintenance drugs.  - George

[George999]

Well the FDA is finally taking another huge step forward.  They are experimenting with fast tracking medications that target the terminally ill and allowing them to skip the safety testing normally required.  DUH!  Finally common sense is prevailing.  When you've got someone with months to live, you worry about the safety of a promising experimental treatment?   I don't think so.  For those of you who are younger and probably not aware, the medical establishment used to worry about the safety of administering appropriate pain relievers to the terminally ill.  No kidding.  And there were many medical professionals that used to obsess over the possibility that there terminally ill patients might become 'addicted' if they didn't restrict pain relief medication.  Thank God we finally got over that one.  Why is this important to us a Peyronies sufferers?  Simply because this means that finally the medical establishment, including the regulators is starting to pay attention.  AND there are indications that they are finally questioning why promising therapies are languishing because they involve generic commodities (like alagebrium chloride and green tea) and thus provide no financial incentive for trials.  If we could finally get over that hill and direct public funding toward those candidates the impact on public health would be immense and we would all benefit.  Why green tea?  Initial research is showing that green tea MAY PREVENT Alzheimer's and other fibrotic syndromes BUT are frustrated because NO MONEY is available for further research because their is no profit angle.  Hopefully the trend continues and further enlightened changes are made in the way things get done in medicine.  - George

[alfapd]

I am new to this forum, but have suffered from Peyronies Disease for a while.  George999 mention VED as a good treatment.  What does this acronym stand for?
thanks

[Old Man]

alfapd:

VED stands for Vacuum Erection Device. They have been used successfully for a number of Peyronies Disease sufferers. It was designed originally for erectile dysfunction. Later, it was found out that with a special regimen of exercises that it would help with Peyronies Disease symptoms.

There is a special thread on the forum devoted to that title, VED, etc. So check it out. Also, in the Child Boards topic on the Home Page, there is many posts compiled into one place so that new guys can learn as much as possible about VEDs and their use. So check out that thread too.

Let us know if we can help in any way. Welcome to the forum!!!!

Old Man

[couldbeworse]

The trend of the AUXL share price is encouraging for Peyronies Disease sufferers.  It just matched it 52-week high (contrast that with the DJIA).  The only product in AUXL's portfolio with promise is the collagenase, trade name Xiaflex.  Even the analysts believe in this drug, suggesting it will make Auxilium profitable by 2010.

As a secondary benefit, Peyronies disease will gather new attention after Xiaflex comes market.  Men will be coming out of the woodwork for treatment and that may inspire other pharma to invest in Peyronies treatment.

In the end I believe that we'll combine treatments like collagenase injections to clear existing plaque, pentox to stave off oncoming bouts of inflamation, and traction/vacuum devices to prevent and correct deformity.

Peyronies Disease sux, but this is the best time in history to ever suffer from this affliction because we might be within a few short years of effective treatment.  Don't give up!

[newguy]

couldbeworse - I definitely agree that peyronie's will be getting more attention in future. I've spoken with very educated professionals in the medical field who are unaware of peyronie's. It's quite shocking really. The development of drugs with potential to treat peyronie's, along with other scarring based disorders will no doubt shine a light in the condition - and god only knows it won't be befiore time.

[George999]

Indeed, I agree very much with the previous two posts.  There is just so much coming down the R+D pipeline right now that bears promise in treating Peyronies.  And, of course, this is a good thing which promises great benefits especially for those younger guys among us.  My only real concern is that, since Peyronies does not occur in vacuum, but happens due to a metabolic environment that encourages its development, even a successful treatment can end in disappointment when the Peyronies returns as soon as treatment is concluded.  So unless we strive to try to correct the underlying metabolic problem, a long term cure is likely to be elusive even in the presence of effective treatments.  - George

[jackisback]

This may be kind of a stupid question, but does anybody think Xiaflex could possibly be described off-label? Seems like no, because I mean often pills are prescribed off-label, but that is because they have tests showing that it is relatively safe to take the pill. Whereas with Xiaflex, you wouldn't be injecting your hand like the on-labelers, you (or more accurately, your uro) would be injecting your penis. I can't see that ANY urologist would be willing to take that risk and start injecting Xiaflex off-label. I read that Aux doesn't even plan to APPLY for whatever it is to get approved for use in America until early 2009, so I'm guessing it will be at least a couple years before Xiaflex could POTENTIALLY be prescribed for Peyronie's treatment given their current phase II status. And from that point who knows how long it would take for the Xiaflex to actually result in noticeable changes? A few months? A year? 2 years? (rhetorical question)

I think Xiaflex in the pipeline will make doctors much less likely to do surgery, but will prove to be a terribly long wait for those currently suffering from Peyronie's.  

[George999]

Off Label is a term used to describe the use of an APPROVED drug for something that it was not approved to treat.  Only drugs already approved to treat some existing condition can be prescribed for off label use.  Xiaflex on the other hand is a drug still in development which has not yet been approved for any use by the FDA.  Therefore it can not be prescribed at all without some unusual dispensation from the FDA.  That is the reality.  Its simply not here yet.  Its on the way, but not here yet.  - George

[jackisback]

Yeah, of course. Sorry for the confusion. But I meant because Xiaflex is in Phase III trials for Dupuytren's, and only Phase II for Peyronie's, it will likely be available to Dupuytren's patients much sooner, maybe by 2009. But unfortunately for us, that doesn't mean that it will be available for Peyronie's then through off-label prescription b/c until further research, we won't know if it's as safe to inject into your penis as into your hand. Although, if any uro is willing to take the risk and offer it off-label to patients, I would imagine it could be a lucrative move.

And if I may vent (just a tiny bit), does anybody else find it interesting that Xiaflex (assuming it works) is being developed by a smaller, start-up pharmaceutical company??? Imagine if Pfizer or Bayer would/had put their resources into this! But I guess it's not profitable enough for them, and in fact, it could have a net decrease on profits from selling expensive erection pills. To me it goes to prove what Winston Churchill once said about capitalism (ok, actually he said it about democracy): that it was the worst system except for all of the others.

[Old Man]

jxyz:

Why did you not just post the link to this research instead of writing the whole dissertation? I don't think that many guys will take the time to read it here. I know that I will not be reading it in detail.

Just my 2 cents worth!!!

Old Man

[George999]

jxyz,  I suspect there are a lot of agents out there that do things that *might* be helpful for Peyronies.  The problem is, what are the short and long term side effects of these agents?  These are issues that would take a lot of time and money to sort out.  And if no one is willing to put up the millions of dollars necessary to sort out those issues to the satisfaction of the appropriate regulatory agencies, those agents will not be put into use.  Its that simple.  When you look at the research, there are all kinds of possibilities, but few of them are really viable in terms of attracting the necessary investment to bring them online.  Personally, I am quite daring.  I have been using a lot of supplements that have been helpful to me.  But even if not thoroughly tested, these substances have all been in general use for some time and are pretty much vetted out in terms of major risks.  I would not dare to touch some of the more exotic stuff even if I could get a hold of it.  It would be risking my life.  No thank you.  Not when I can block many of these same pathways with something like Pentoxifylline which has a long history of safe use.  - George

[Tim468]

Fascinating new directions (though I agree very hard to read these online  I only post entire articles if the links do not really go to full text). Lots of new stuff to hope for.

Tim

[jmaxx]

Today I mailed six articles pertaining to Pirfenidone to Dr. Levine and Dr. Fedunok, a uro at University of Chicago.  
We have to make ourseves and our pain heard!!!  You people do great research here yet you sit on your ass with the potential solutions.  
We have to be vocal!!!

In order to make their suffering heard a group like Mothers against Drunk Drivers are very vocal.  They are in your face vocal.  Call your uro, print and mail your peyronie's articles, TGFb-1 articles, any promissing research.  Keeping it to ourseves on this board is not going to help us.  Be vocal!!

I'll bet you that within a month I well be taking Pirfenidone prescribed by Dr. Levine.  I will not take no for a answer!  I will not sit by quietly while I suffer!

I implore you to call and write your ero.  Like I said, Mothers against Drunk Drivers had to harrass lawmakers to get their point heard.  I am saying harass, persistently, unrelentingly!


Font size changed to a normal font in compliance with forum rule #5 - Administrator

[Old Man]

jxyz:

Sorry that you take such an approach to the good work that has been done so far on this forum. I don't think that you have made many points with the members by posting is such bold type and using exclamation marks to end your sentences.

I believe that most of us on this forum are grown up adults and we do not have to resort to such tactics to make ourselves heard or known.

Hope you have good luck with your emailed articles and your visit with the good doctors you mentioned.

Old Man

[jmaxx]

"Sorry that you take such an approach to the good work that has been done so far on this forum."  

It's not good work if it doesn't get off this form and infront of our eros, senators, congressmen.  How many congressional forums on breast cancer have we seen on CNN, plenty!  Women had to become activists to get better healthcare.  Many of them unashamedly living by the words (History is rarely made by the well behaved woman)   The same women beleaguered, bothered, badgered all those who can make positive changes for better female healthcare.  That is what men need to do and that is how we will draw more attention and funding to our disorder, by becoming activists.[/size]

"I don't think that you have made many points with the members by posting is such bold type and using exclamation marks to end your sentences."

Deal with it!

"I believe that most of us on this forum are grown up adults and we do not have to resort to such tactics to make ourselves heard or known."

What is your tactic old man?  Sit on a (single) forum, remaining unheard and unknown.   Let me quote Newguy;

"I've spoken with very educated professionals in the medical field who are unaware of peyronie's. It's quite shocking really."

I am saying become an activist.  Write the endowments who supply money for research grants...write to at least two eros a day.  Beleaguer them, bother them, badger them.  Don't let them forget we are here.  

To bad you choose to live a quiet life of desperation.  I'm not going to end up like you old man.

Font size changed to a normal font in compliance with forum rule #5 - Administrator

[Old Man]

jxyz:

No, I don't have to deal with it, you do. I have been on this forum as long as any one and have a good reputation of helping others. So, if you think that you can come so strong, why don't you just go to another forum where your kind of remarks would be accepted and appreciated.

We do not have to put up with the likes of your sarcastic remarks at any time. If you would use the forum in the manner that it is set to be, you would be better served. Just keep up what you are doing and see what happens.

Thanks for your ridiculous remarks posted in bold type. Are you so small that you have to use large letters to get your point across?

Old Man

[George999]

To bad you choose to live a quiet life of desperation.  I'm not going to end up like you old man.

With an attitude like that you are not going to get much respect from many of us around here.  If you think we are all doofisses, you are welcome to try to show us all how its done, but don't try to use our forum to ridicule us.  And you are going to find out that there is a lot more standing between you and Perfinidone than Dr. Levine.  You have better be writing letters to the pharmaceutical company that makes it AND to the FDA among others.  As much as I would relish a prescription for Perfinidone (and make no mistake about it, I most certainly would love to have access to it), there are some good reasons why I can't get it at this point.  Turning it loose to all those who might benefit at this point could end up jeopardizing the long term viability of the product.  Testing and marketing these products costs gazzillions and all it takes is one misstep and the whole project is back to the drawing board.  You are so wet behind the ears and so arrogant, you have no right to respond to Old Man the way you did.  He has probably done more to better our lot than you will ever achieve.  Those are my sentiments.  - George

[Tim468]

Dear jxyz:

Most of us can understand and empathize with passion. Most of us feel strongly about various aspects of this problem. But we are not all things for all people. We are not necessarily "advocates", or activists in a cause. We are here because we share a problem and this is a support forum. So while I understand your passionate feelings about the need for advocacy, that does not make it proper or your right to engage in personal, ad hominem attacks on individuals.

I could point out how much help Old Man has been to others, but others already have done so. His help has been primarily through discussing and advocating - here - what has worked for him. What he has recommended has helped innumerable people.

A life of "quiet desperation"? I don't think so. He has had Peyronie's for over 50 years and has found a way (unlike most of us) to control it and to regain his penis' function. He has an active sex life in his seventies. Sounds more like a goal to aspire to, rather than a path to revile. The fact that folks will surely rally to his defense will speak to the value of what he shares.

I do not need to know why you suddenly shifted gears here. You have made over 20 posts, most sharing up-to-date information on research with appended questions regarding the applicability to Peyronie's care. You have expressed gratitude to others for the information that you have received that helped (i.e. your post expressing thanks for the information on supplements). https://www.peyroniesforum.net/index.php/topic,22.msg12909.html#msg12909

More recently, you have expressed frustration, describing the supplements as those you have "wasted" your money on.

We can all relate to frustration, but "shouting" at others through the use of larger fonts, along with personal attacks will not be tolerated. We do not have a ton of rules here, but have thrived through decency and mutual support. Please respect this accepted and commonly agreed upon mode of interaction with others here.

Tim

[ocelot556]

I'm also going to point out the dubious effectiveness of such an "advocacy" -- there are promising treatments on the horizon for MS, arthritis, alzheimers, etc. -- diseases that affect a much, much larger portion of the population. If all it took was advocacy these diseases would be a thing of the past - there are charities and infrastructure devoted to these potentially fatal and more debilitating diseases than there ever will be for a disease that affects a small percentage of a gender that makes up less than half of the population. I hate hate hate the FDA and the red tape it needlessly winds around progress (and the fact that enough $ can get something like Vioxx through) but it's in place to help ensure that the incredibly complex drugs that are being manufactured won't do more harm than good.

I check this forum more than all of the others. Why? Because I'm young and I hate that I have this disease, and this forum is the greatest hope we have. Sometimes I despair too, and think the economy will collapse or some other disaster will occur and stall or stop this research, but you're wrong to take out that fear/anger/aggression on the small population of people out there who are WILLING to help you. Most Uro's don't know much about Peyronies Disease -- most people on this forum do. Please, go and advocate for us - but don't cut off your nose to spite your face.

[Hawk]

To Old Man, Tim, Ocelot, George:

Well said!

[j]

Peyronies is a form of fibrosis, and there's lots of research already going on regarding fibrosis, for other reasons.  Fibrosis is a big problem with radiation treatment for cancer, for example.  New antifibrotic drugs may very well turn out to be effective against Peyronie's as well as other, higher-profile conditions.

Also, let's not forget: the one and only drug which has definitely shown success against Peyronie's - injectable collagenase - is in Phase III trials and apparently still grinding its way toward the market.  These things take so ungodly long  - the road is so twisted - that eventually the "process" just becomes part of the landscape and we stop thinking or talking about it, because it's frustrating.  But in this case, I think it will go to completion, and guys who actually have Peyronie's (and not some conjunction of other problems and anxieties) wil be able to get real improvement.  

If you want to be an advocate, then buy shares of Auxilium, show up at a stockholder meeting, get in front of the microphone and demand to know what's happening with this product.  

[George999]

j, Thanks for a few words of sanity here.  As you note there are products in the pipeline with huge potential and Collagenase is one of them.  AND there are a number of doctors AND researchers that ARE sympathetic to our plight.  We need to encourage them, not anger them by insinuating that they don't care about us.  Thanks again for a great post!  - George

[Steve]

 
I ran into this document titled "Medical Management And Surgical Management Of Peyronie's Disease" today...
http://www.medicalnewstoday.com/articles/117599.php

with the following statement about medical management (vitamin E, potaba, Colchicine, Tamoxifen, Carnitine, Pentoxifylline, and PDE5 inhibitors ):

It is clear that rigorous well-designed controlled studies have in the past not been uniformly done. They are needed, and we are in an era where that deficiency is being addressed.

I'd like to know just where these studies are being addressed?  Anyone know of anything?

[sams]

Check the article. Xiaflex could launch by late 2009. We all could make good money pn the shares based on what we know. However, i will be very happy if there is a cure for this next year.

http://www.marketwatch.com/news/story/swinging-fences/story.aspx?guid=%7B4D97A2D5%2D0A50%2D47A8%2D9A74%2DD04406AB3C93%7D

[George999]

BioSpecifics Technologies Corp. Reports Second Quarter 2008 Financial Results

"In the second quarter, successful pivotal Phase 3 results for XIAFLEX(TM) to treat Dupuytren's Contracture were announced by our partner Auxilium, Inc. We continue to expect a biologics license application (BLA) filing for this product with the U.S. Food and Drug Administration in early 2009. In addition, we expect Auxilium to initiate a Phase 2b trial for XIAFLEX in Peyronie's Disease later this quarter," commented Thomas Wegman, President of BioSpecifics Technologies Corp.

This does indeed sound promising!  I suspect the trick here will be to keep the lid on inflammation with current treatments whilst blowing away the scar tissue with Xiaflex.  Once the scar tissue is gone and the whole thing has healed, there should be no further stimulus for any further inflammation.   - George

[alcohen]

I found this post over on the BTC Discussion forums:

"I have been in the Xiaflex test program for near 3 years.  I would drive to Erie, Pa 70+ miles countless times over that span. First the drug was tainted with moisture and I had to wait a year for another chance.  Then I recieved the placebo and had to wait again.  Then I finally got the real thing and my first joint on my little finger went from 50% bent over to 0%, straight over night.  I need only one more injection for the next joing up and my hand will be completely recovered.  I am enjoying doing small things I took for granted for years like shaking hands, and for all of you whom are waiting for this drug it is purely amazing, do not get surgery, I waited and it is worth it.  NO SCARS, and use of your hand within days."

Granted, this was testing done for Dupuytren's disease but CLEARLY this is promising news!!!!

Thoughts?  

I am starting with my uro, Culley Carson at UNC Hospital on Monday, and maybe this is a trial that I can be put on...  I have heard there is a trial of Xiaflex with Peyronie's taking place in Virginia.  

[jackisback]

I posted this on another thread, but check this out http://www.theindychannel.com/health/16902359/detail.html

Also, this is just an average Jane on youtube http://www.youtube.com/user/samanthahoffman

I think I just watched her last video, and even though it didn't look that great (def not 100%) she said that it made a huge difference, so that's good!

I have much hope that Xiaflex will come to cure this terrible condition. No one should have to suffer such a ridiculous disease.

[sflo]

this looks so promising. wow i am crossing my fingers for such a thing. This would not be a cure but definitley help  a lot of us I bet. What is the deal and where are they currently for using this for peyroines?