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

[newguy]

Once apprpved, I personally don't think it will be all that long before doctors offer it as an option, and for a price, even if there are some unknowns.

[ComeBacKid]

Isn't the point that by the time the FDA approves it the xiaflex studies will be complete and out there for examination?  I mean how long are they going to do the studies and not publish anything?  At some point people will start critiquing the product and the motives if there are no studies....

Comebackid

[George999]

Remember, the FDA approves medications for specific uses.  In order to gain approval for other use(s) requires additional studie(s).  But, of course, these additional studies don't have to start from scratch.  They simply get grafted in to the previous approval process at the appropriate level.  But more studies are still required for approval for new uses.  Otherwise, you are left with the whole off-label thing like you have with Pentox.  I would hope that Xiaflex would be approved for Peyronie's before it goes off patent so we can avoid that, because once it goes off patent, you can forget any more FDA approved uses.  - George

[newguy]

Do you think treatments such as Perfinidone, Collagenase, and Alagebrium will see the light of day as useful drugs in the treatment of peyronie's?

The alagebrium website appears to be state that studies are still ongoing: http://www.alteon.com/therapeutics/alagebrium though the wikipedia page appears to be more downbeat about the prospects (though, anyone can edit that I guess). Are there any movements or further studies relating to Collagenase and Perfinidone?

[George999]

All three of those are currently somewhere in the trials process.  Whether and where they will emerge is anybodies guess.  Of course collogenase in the form of Xiaflex looks promising for Peyronie's.  Perfinidone looks promising for Peyronie's BUT there are going to be questions regarding its long term safety for years to come which will likely rule it out for Peyronie's use, this, not to mention its prohibitive cost.  Alagebrium, also promising. faces questions in terms of its owner's financial viability and capability to get it on the market for some use in order to produce income.  - George

[newguy]

George - Xiaflex is certainly of interest at this point and feels like it's almost within our grasp... well compared to the other possible future treatments. In retrospect I wish there had been a seperate thread for it, because it's quite difficult at times to get a rounded view of how the treatment is going for people and a flow of conversation (tho I appreciate that there is a search button, and know that there is no easy way of dealing with this matter due to the forum structure - it's only a small point anyway . Xiaflex appears to have received mixed reviews from those here, so it'll be good to see results filtering through.

Alagebrium is perhaps the most intriguiging one of the three drugs I mentioned, and it's very unfortunate that there are funding issues. The wikipedia page is quite interesting and informative concerning the history of Alagebrium: http://en.wikipedia.org/wiki/Alagebrium

[ocelot556]

George - when the patients sued the makers of Pirfenidone, they forced the company to make it available to them for life and death cases. Couldn't that precedent be set for Algaebrium? It's supposed to cleave crosslinks formed in diabetics - isn't this a sound diabetic treatment? I know it's very cheap to make and easy to copy, hence not a large profit motive in it, but is it possible that legal intervention can take place to make them provide it to the public? It's not surprising, but still horrible, that something that seems so beneficial to so many with diseases far worse than ours can't be helped by a drug...because it's TOO easy to make and mass produce!

[George999]

George - when the patients sued the makers of Pirfenidone, they forced the company to make it available to them for life and death cases.

Yup, because they already had study data in their hands illustrating its effectiveness.

Couldn't that precedent be set for Algaebrium? It's supposed to cleave crosslinks formed in diabetics - isn't this a sound diabetic treatment?

If there were conclusive study data to demonstrate that.  I'm not sure there is at this point.  THAT is the problem.

I know it's very cheap to make and easy to copy, hence not a large profit motive in it, but is it possible that legal intervention can take place to make them provide it to the public?

Legal action against WHO?  The FDA?  They are the roadblock at this point.  I'm sure Synvista would be happy to be able to market it.  They would have to pressure the FDA enough to get them to allow it.

It's not surprising, but still horrible, that something that seems so beneficial to so many with diseases far worse than ours can't be helped by a drug...because it's TOO easy to make and mass produce!

Its sort of the same problem as what we face with Pentox except that Pentox IS approved for other uses.  Just about everybody who has ever used Alagebrium is reporting benefits, but that is not enough to win FDA approval.  They want studies which cost $$$$$$$$$$$$$$$.  Where is all that money going to come from?  - George

[newguy]

Would it be possible, or easier, for them to get approval in a different territory without requiring such large amounts of funding?  Also, did their trials start up again, since they terminated from at the end of January? http://www.reuters.com/article/pressRelease/idUS240508+28-Jan-2009+PRN20090128  It's quite frustrating, as Alagebrium itself seems to be cheap to produce. Still, I guess we should be heartened that such discocveries have even been made and may eventually benefit millions.

[George999]

Its worse than that.  There are a lot of therapies known to hold great promise that are likely to never see the light of day due to the fact that nobody can make any money off of them.  Things happen not because they can benefit mankind, but the prime mover is only that they can make someone money.  This is a reflection of a broken system, since it should be the role of government to identify things which can greatly benefit society and fund those things with public money in the public interest.  But that whole approach is not in vogue these days.  If it can be privately developed its toast.  - George

[newguy]

George999 - You'd think that in these circumstances, another country would take the lead by offering the streamlined approval process, so that at least it was available in many other countries, and effectively could be distributed worldwide. I suppose money is still a factor though, as if something is cheap to produce, there will likely not be much of a profit margin in it for then, and other companies elsewhere (india etc) will produce generic versions which would cut into their profits yet further.

[slowandsteady]

Alagebrium is perhaps the most intriguiging one of the three drugs I mentioned, and it's very unfortunate that there are funding issues.

There is a nice summary of alt-711 research at this site. In a study of diabetic rats (PMID 16490017):

RESULTS: Erectile responses to CNS and penile nNOS protein content were significantly reduced, while AGE levels were elevated in the penises and serum of untreated diabetic animals. Treatment with ALT-711, but not with aminoguanidine, reversed ED and nNOS depletion and reduced serum and penile tissue AGE levels.

I've been taking generic alagebrium since January of this year. While I don't have ED, I saw a benefit in terms of a better erection after just 2-3 days taking about 80 mg/day. I perhaps haven't been taking it as regularly as I should have, as I take it on average one out of two days a week.

While the anti-ED effects really stand out, I have unfortunately not seen much in the way of a big anti-Peyronies Disease benefit. I may up my dose to 70 mg twice daily for a while to see how that goes.

s&s

[ocelot556]

You can acquire generic versions of the drug? If that's the case, I'm surprised it hasn't been mentioned here before.

[newguy]

An interesting post about Alagebrium, or rather AGE Breakers Beyond Alagebrium : http://agebreaker.72pines.com/2007/05/14/age-breakers-beyond-alagebrium/

From this it appears that Alagebrium breaks down one particular type of AGE (diketone crosslinks), when in fact there are several. As such the effectiveness of Alagebrium likely depends on the type of injury/complaint, because different crosslinks are likely involved depending on issue at hand. It seems that glucosepane may be the most common AGE compound in humans, and Alagebrium doesn't break this down. A number of companies are working on discovering a glucosepane AGE break though.

Don't take this to mean that alt-711 is ineffective, but rather that it doesn't alter certain types of crosslinks and in future there will likely be a more rounded and effective approach to dealing with them.

EDIT: Also, I had no idea that aspirin may also inhibit the formation of pathological A.G.E. crosslinks. Of course, that doesn't help where existing crosslinks are present, but it's useful too know. On a cautionary note, I wouldn't advise people to take an excessive number of bloodthinners (vitamine e, aspirin etc), especially if they use, or intend to use the VED.

[newguy]

Australian scientists say they have developed a drug with the potential to save millions of lives from kidney disease.
The scientists from the University of Melbourne, St Vincent's Hospital and Bio21 Institute say the drug may prevent a condition responsible for up to 45% of all deaths in the western world, mark an end to dialysis for patients with kidney disease and reduce the need for organ transplants.

The team say the breakthrough drug FT-11 works by preventing the spread of fibrosis, the irreversible scarring of vital organs, which is the underlying killer in illnesses such as kidney disease, diabetes, heart failure and lung and liver problems.

Currently there is no available treatment which prevents or halts the spread of the condition and the race is on to produce an antifibrotic drug.

In preliminary trials on rats FT-11 had a 100% success rate with no side effects and human trials on 30 patients are expected to begin soon.

Professor Darren Kelly who has led the two-year research project, says it could save the lives of millions of patients around the world and bring an end to kidney dialysis and also offer an improved lifestyle.

Dr. Kelly says FT-11 has the potential to be a block buster drug with enormous financial rewards; Melbourne University shares patent rights for the drug through Fibrotech Therapeutics.

The plans are for the drug to be initially developed to treat kidney disease caused by diabetes and could mean the difference between taking one tablet a day as against needing eight hours of dialysis every few days; the drug could also be used to prevent diabetes.

Kidney Health Australia, says fibrosis causes the majority of chronic kidney diseases and any drug that could stop the onset of scarring to the kidney would be a major advance. There are currently 10,000 Australians on dialysis.

According to Professor Kelly if clinical trials are successful the drug could be available within eight to 10 years.

- www.news-medical.net/?id=40755

Another possibly useful drug some way down the line. Who is to know whether it will be effective in trials, but it's another example of the progress taking place in this area.

[Jackieo]

newguy:  Thanks for sharing this report.  It is very hopeful...once again, it shows how so many things are connected and that we are not in this alone.
JackieO

[newguy]

newguy:  Thanks for sharing this report.  It is very hopeful...once again, it shows how so many things are connected and that we are not in this alone.
JackieO

Yes, that's right Jackieo. I know that guarenteed solutions are not available for us at this time, but there is a great deal of research taking place because there are massive implications (and money to be made) for effective treatments in these areas. Also, it's easy to sometimes think "what are people doing for us" when really, so many people are suffering conditions that are actually life threatening. They are living day to day praying that these drugs will emerge, and however intensely horrible our own situations are or may become, at least most of us do not have concerns on that scale. It can be difficult to count blessings when we are involved in such a struggle, but sometimes I do manage to do so, and I think it's a healthy mindset to achieve.

[Tim468]

Sigh...

Still seems like it would be easier to stop eating refined carbohydrates in excess, to stop the ravages of diabetes.

Tim

http://www.nytimes.com/2002/07/07/magazine/what-if-it-s-all-been-a-big-fat-lie.html

[George999]

In addition to all of this, we currently have a political leadership in this country that is VERY serious about channeling more $$$$ to research.  This is the first time in a long time that this has been the case.  That is a VERY good sign.  Previous administrations have given lip service to research, but have created public policy that has hindered it.  The last president to vigorously support research was JFK and that effort got us to the moon and beyond and brought a number of key medical advances in the process.  Over that period and in its wake a number of 'untreatable' medical conditions became literally curable.  I am thinking especially of cardiac issues.  - George

[newguy]

Are there many people out there taking part in the xiaflex trials who have experienced reduced curvature? A few have got back to us, but it'd be nice to get some updates from those taking part, or from those lurking on the site..

Should xiaflex ultimately not prove to be very useful for peyronie's, what do we propose would be the reason for this? I'm not trying to be unduly negative, simply thinking of all of the eventualities.

[Hawk]

In addition to all of this, we currently have a political leadership in this country that is VERY serious about channeling more $$$$ to research.  This is the first time in a long time that this has been the case.  

That sounds like a statement from someone that has bought into political rhetoric and not looked at the actual ledger.  This is not the time or the topic for a protracted debate but it is my opinion that you could not be more wrong if you think medical research will be better funded in the next 4 years.

[Hawk]

Sigh...

Still seems like it would be easier to stop eating refined carbohydrates in excess, to stop the ravages of diabetes.

Tim

http://www.nytimes.com/2002/07/07/magazine/what-if-it-s-all-been-a-big-fat-lie.html

Tim,

I share your sigh.  People that like to attack carbs make no distinction between refined and complex carbs.  My son has lost 100 lbs in the past year eating complex carbs & protein with very low fat intake. He is "ripped" with very low body fat and clear muscle definition.  He obviously exercises.

[Hitman]

my personal experience has been that the carb quantity matters more than the type of carb. thats been the case with my diabetic sister at least. I also have had great success with a low carb high fat moderate protein diet. Of course the word low would vary from one person to another. I also think saturated fat gets a very bad name.

[Tim468]

Gary Taubes, who wrote the seminal book (though many folks don't know it yet!) called "Good Calories, Bad Calories" eviscerates the AMA, ADA, AHA and supporting governmental bodies for their low fat dietary recommendations that emerged from the McGovern report on nutrition in 1977. There was overwheling data to support the "alternative hypothesis" that carbs were the proximate cause of obesity and most health problems related to "Westernization", but the cardiologists recommending dietary change didn't know that literature (or believe it if they knew it).

Since then two things have happened.  First, primarily through the emergence of high fructose corn syrup, Americans have added 30 pounds of simple sugars to their annual diet in the forms of glucose, sucrose (which is a 50/50mix of fructose and glucose), and "high fructose" (~55/45 split) corn syrup - overwhelmingly the latter.

But in addition to the addition of 30 pounds of sugar (taking us to an average of 150 pounds per capita per year!!!), the annual intake of grains has increased by 60 pounds per person per year.

The effect of the low fat dietary recommendations has been to shift our intake over to to less fat, and by definition, higher carbs. "Low fat yogurt", Cheerios... you name it - all in the name of a "heart healthy diet". But sugar or high fructose corn syrup remain high on the lists of ingredients for all these items.

And with a change in the makeup of the diet, came an increase in the amount of calories taken in (approx 400 calories more per day). So, yes, more in means more stored, but the laws of thermodynamics are not simple and did not apply as is often stated (that "a calorie is a calorie is a calorie").

Instead, insulin secreted when we eat carbs causes the avid uptake of triglycerides into fat (not just the shunting of glucose into muscle cells). We are left in a chronic state of hunger, as much dietary fat is removed from circulation and stored, and we have higher cravings of hunger.

So rather than sloth, gluttony or other moral judgements about obesity, we could see it as a disorder in fat metabolism. We could see less activity as the result of the altered metabolism, and not the cause of the increased weight gain. We could see the increase in appetite and not due to bad character, or flaws exploited by evil empires of corporate bad guys conspiring us to eat their food (though they do exist!) - rather, we could see the weight gains as due to a large change in our national eating patterns that were unparalleled in history - ever. And the primary driver of that is carbohydrate intake - simple and more "complex".

When we eat whole grains, we get more micro-nutrients - it is not the same as having them added back in the form of "enriched" flour. But the process of milling and refining flour, although it allows us the food to survive longer as it is more resistant to rotting, promotes faster absorption of calories and the release of insulin. Again, insulin is the primary driver of fat storage and carbs in any form are the primary driver for insulin release.

So, complex carbs that are slowly absorbed simply cause less insulin surges, and the micronutrients are better for you. The absolute amount of carbs is also far lower. What used to be called the low carb density foods (some are better for you than others) include Kale (5%) versus potatoes (40%+).

So "complex carbs" that include fresh fruit and leafy green vegetables are different than carbs that include grains, grain products and sugars. I think the "iffy" zone is in the whole grains. These are better for you than refined white flour due to better nutrient value, but may still give you the hit in insulin that one needs to avoid. Even when looking at fruit, it helps to compare the density of carbs to weight of the food.

Hell, even putting anything sweet in your mouth causes an immediate release of insulin, which may account for the fact that folks drinking diet pop still tend to gain weight over time.

Tim

Here is the link again:
http://www.nytimes.com/2002/07/07/magazine/what-if-it-s-all-been-a-big-fat-lie.html?sec=health&pagewanted=print

[George999]

Tim,  I certainly agree with that assessment.  Many people succeed with diets that cut fat to the bone or cut carbs mercilessly or other radical diets BUT that success seldom lasts.  In the end, hunger asserts itself and things can go downhill fast.  Instead we need to understand that ALL these nutrients are necessary INCLUDING a reasonable amount of GOOD fats.  On the other hand, all these nutrients exist in toxic forms which we need to avoid.  A lack of understanding about the foods we are eating is devastating our health.  A lot of people also are taking to "juicing" for health and weight loss.  This article indicates how that trend is ruining people's teeth among other potentially negative impacts.  The reality is that a lot of foods sold under the cover of being healthy are actually among the worst offenders.  - George

[Hitman]

I firmly believe thats if its pure fat loss and retention of muscle mass you're looking for, a full keto diet works best. Of course you have to be principled enough to follow such a diet and there are many variations of the diet that make it doable and manageable. The problem with a Low fat, low calorie high carb diet is that while you do lose a significant amount of weight you also drop a lot of muscle mass.

I also believe that the biggest problem is AGE. As far as whole grains are concerned, I think the concern is with phytic acid.

[newguy]

I agree with most of the recent statements. I have all but cut refined carbs out of my diet. I used to eat sweets (candy to my american friends quite often, but I can't remember the last time I did in recent times. I avoid anything excessively sweet really (including sweeteners) and whenever I literally have to eat something sugary (like cake at a birthday party) it tastes insanely sweet to me. I eat lots of fruit and veggies though, but typically the actual fruit rather than drinking juice. I feel that juice it's likely to cause a spike due than eating actual pieces of fruit. Also, it's very easy with fruit smoothies to drink a whole carton, then realise than you've guzzled down a hampers worth of fruit and 100g+ of sugar in about five minutes:  http://www.innocentdrinks.co.uk/things_we_make/smoothies/carton_black_rasp_boysen/  I think you CAN have too much of a good thing .

[j]

I've been following the reports of dietary research since the 70s and I think I finally understand what the experts are telling us.

Fat is bad - no wait, fat is good.  Sugar is bad, it's always been bad, except it used to be bad just because it was empty calories - now we know that glycation  is aging our brains, so no sugar.  Dark chocolate is good, it's full of antioxidants.  But where do I get chocolate without sugar?   Carbohydrates are good - no, today only complex carbohydrates are good.  Um, but wait, they contain sugar so maybe not so good.  Fruit is definitely good. Fruit is a health food!  But fruit also has too much sugar.  So "an apple a day" is out. Except we have to have fiber, and apples have fiber - wait, I think the link between high fiber and reduced colon cancer has just been discredited. So I guess fruit is out?  But it has vitamin C which prevents cancer - or used to, I don't think it does anymore.. Red meat is bad, we all know that from way back. Oops, not anymore - now protein is good. So lean meat is good and fatty meat is bad?  No I think the latest is that the fat is good, too.  The Innuit live on blubber!  Fish is very good. Unless it came from the ocean, or a lake, or a river - then it probably contains too much mercury.   Fish oil is good if you can get it without the mercury.   Cholesterol is very bad, it clogs your arteries.  Well actually today only bad cholesterol is bad, and good cholesterol is good. But don't they come from the same place? I forget...  

Broccoli was good in the 70s and is still good today, although the reasons are different. Broccoli is a survivor, a winner, like if you'd bought a share of Berkshire Hathaway way back when.  But it's not good for breakfast.

Smoking is bad.  I'm quite sure about that.

[Hawk]

Smoking is bad.  I'm quite sure about that.

....but what if we smoke Broccoli

[j]

Exercise is good. Antioxidants are good.  So we exercise and take antioxidants, right?   Ha.

http://www.nytimes.com/2009/05/12/health/research/12exer.html?_r=1&em


It's like the investment advice we get from money gurus via TV and magazines. One thing is certain: whatever we did with our money last year was exactly the wrong thing.  As for what we should do now, well that's a little tougher - we're supposed to carefully examine our personal financial goals and consider a range of investment options...  based on our own tolerance for risk...  

[UK]

Here is some new info on Xiaflex, that you need to interpret how you see fit, but tallies with what some of the posters on this forum have been suggesting

http://industry.bnet.com/pharma/10002040/pfizers-penis-straightening-drug-may-cause-swelling-redness-and-bruising/

Either way we have about 4-6 months to wait for the high level results from the Phase IIb study, if they are reporting in the 4th quarter.

[j]

In my opinion the guy who wrote that article is just a bonehead with no real understanding of what he's writing about.

Swelling and redness are no surprise - this enzyme is literally dissolving tissue, it's an active process, not a magic wand.   If you read the actual quotes from the Auxilium people, they aren't concerned.  The article contains other misinformation too - Dupuytren's disease does not "deform the hands into claws", that's just plain silly.  


I'll bet he's shorted the stock.

[newguy]

j - Not sure what to make of the vitamin + exercise study. Personally, at this time I still think that the benefits of exercise, a healthy diet and supplements is the way to go, and outweight any possible negatives.

UK - I don't think the articles emphasis on "swelling, redness and bruising" is very professional. The conference call as good as states that any injections into the penis can cause this type of reaction, so it seems as it the bnet article is looking for an alarmist angle. It's all about weighing up the options anyway. Maybe in some individuals injecting anything will actually make their condition worse, but if the results of the trials are, on the whole, positive and show that xiaflex does benefit most people, then it makes it a viable option. Of course, right now the jury is out on whether it will prove to be viable, but if it is, then in combination with healthy living, supplements, pentox, and so on, hopefully we're in a better position than most to maximise the pros and limit the cons.

[George999]

I find the anti-oxidant study a bit disturbing.  The whole thing about the body using free radicals as markers is novel, but quite likely real.  If that is indeed the case, then we just might be doing the body a disservice by preempting it with antioxidants and making it somewhat blind to problems.  Certainly as a result of this news, I will be scaling back on anti-oxidant use.  This comes right on the heels of research tying certain B Vitamins, including folic acid, which has been highly promoted, with increased incidence of cancer.  So, in both cases, perhaps we ending up fixing one thing and screwing up something else.  I think the real solution here lies in the development of blood panels to access deficiencies and allow the patient to correct them without having to use a blind shotgun approach where the nutrient that is being supplemented the heaviest is actually the one that the patient has an excess of and the deficient ones end up not repleted at all or not sufficiently.   - George

[newguy]

I find the anti-oxidant study a bit disturbing.  The whole thing about the body using free radicals as markers is novel, but quite likely real.  If that is indeed the case, then we just might be doing the body a disservice by preempting it with antioxidants and making it somewhat blind to problems.  Certainly as a result of this news, I will be scaling back on anti-oxidant use.  This comes right on the heels of research tying certain B Vitamins, including folic acid, which has been highly promoted, with increased incidence of cancer.  So, in both cases, perhaps we ending up fixing one thing and screwing up something else.  I think the real solution here lies in the development of blood panels to access deficiencies and allow the patient to correct them without having to use a blind shotgun approach where the nutrient that is being supplemented the heaviest is actually the one that the patient has an excess of and the deficient ones end up not repleted at all or not sufficiently.   - George

That's the ideal. Even without that, I think the average person would benefit from keeping a close eye on their diet for a period of time, then seeing what is missing and what isn't in terms of nutrients. for instance, in hindsight my Vitamin D intake was pitifully low.  Maybe in time it will be revealed that megadoses of any vitamin really cause more harm than good. Supplements should supplement, rather than provide the basis for healthy living or patch up a bad diet. This study hasn't really worried me iun relation to anything I take, other than possibly vitamin E, which I do take reasonably high doses of. I'll stick with it for the time being, and see if future studies reveal similiar findings.

[Tim468]

I found the original article online and it is a dense and tough read - not sure about their conclusions yet.

Tim

[George999]

Tim.  I think that what we are discovering about folic acid is really instructive.  WITHOUT supplementation we know that we will see increased incidences of birth defects and such.  WITH supplementation, we know that we are seeing increased incidence of certain kinds of cancer.  This would indicate that rather than comparing supplementation with non-supplementation, we need routine annual serum folic acid measurements on a broad group of people.  We THEN need to be comparing birth defects and cancer rates and we need to determine optimum folic acid levels.  We will likely find that only a small subset need to be supplementing, for many others it will be optional, and for some others, any supplementing at all will be risky.  And I think that this strategy will likely apply to other key supplements as well.  Nutritionists have been criticized for doing this sort of stuff for years.  But there application of it has been questionable, since they have not really identified optimal blood levels via long term well controlled studies.  BUT, their concept has been a good one.  As it is now, a few people are suffering because of a deficiency of [ fill in the blank] ... so we tell everybody to start supplementing with it.  Wrong!  (and not very scientific)  - George

[ocelot556]

http://www.reuters.com/article/pressRelease/idUS240508+28-Jan-2009+PRN20090128

Well, it looks like the almighty dollar has set algaebrium back another ten years. So much for progress... I'm losing hope that anything will ever be developed for our condition!

[j]

Xiaflex was on, off, on again for years as the money ran out and new funds had to be raised.  If alagaebrium  has real value, someone else will buy the rights and restart the trials.

[Iceman]

we are all doomed - nothing good about this - very very very DISMAL

[cowboyfood]

we are all doomed - nothing good about this - very very very DISMAL

No, but Synvista may be.  I'm not up to speed with this potential drug, but I did notice a few things about the press realease.

First, it's dated January 28, 2009, almost six months ago.

Second, that press release contained a dire forecast about it's potential implosion:
"The Company is continuing to explore strategic alternatives in order to monetize its technology assets, which may take the form of sales or licensing transactions with respect to those assets.  In light of the Company's cash position and current negative economic and capital markets conditions, if the Company is unable to enter into such transactions in a timely manner, the Company's ability to continue operations beyond the second quarter of 2009 is in doubt."

You hate to have to put that in a financial disclosure.

Finally, the company decided to delist from the NY Stock Exchange last February and it's currently trading for $00.13 per share on the OTC.

Sorry in advance if my observations are old news, but the press release is old new.

CF

[LWillisjr]

we are all doomed - nothing good about this - very very very DISMAL

Sorry to disagree Iceman. I agree that the whole issue with Alagaebrium is disappointing. But I have seen very few positive comments from the Xiaflex trials. I know many in the trials have purposely not been posting, but you would think that if there was a good percentage of those seeing improvement that we would have heard about it somehow. I think at best this may have been another thing to try that may have worked for some and not for others. There was no indication that this was the all mighty cure. No different than a Verapamil alternative in my opinion.

And to say we are all doomed I assume is more of a figure of speech. Many have seen improvement from the current forms of treatments including traction, VED usage, Verapamil, drugs like Pentoxifylinne, supplements, and yes..... even surgery. I think the worse thing we can do for new forum members is to give any indication that "there is no hope" and "nothing can be done".  Sort of like the message I hear from some uninformed urologists.      

[newguy]

I agree with the below comment. We have a responsibility to think carefully about what we write here. I wouldn't want new members to find this site and feel even worse than before they arrived here!

[George999]

We are NOT doomed, far from it.  The reality is that Alagebrium is available.  At least one person on this forum has been using it.  Trials will not make it work any better or any worse.  IF it proves helpful, more of us will likely gain access to it.  BUT, and this is a big but, viewing Alagebrium (or anything else) as the final cure is part of the problem.  NOTHING on the horizon today is the "final cure", BUT there are a lot of things that can be helpful.  Auto immune syndromes all tend to wax and wane in some pattern.  We get better and feel upbeat, then we suffer a setback and feel depressed.  We have got to break this cycle.  We have got to learn how to use things like Pentox to temper the setbacks.  We have got to find more things like Pentox to temper the setbacks, and most of all, we have got to learn to temper our psychological responses to the setbacks.  Why?  Because the REALITY is that people who are positive and optimistic in the face of adversity do considerably better physically than those who crumble under trial.  So look at the bigger picture.  Be thankful for the good times and be willing to fight like a tiger through the bad times and not throw in the towel.  We WILL be doomed IF we doom ourselves by being defeatist about this.  - George

[cowboyfood]

Thanks George999, Newguy, and lwillisjr...

and, hopefully my particular post was to point out that it sounds like the termination of the trials was based on the overall economic health of the company and not the effectiveness of Alagebrium.

Financially, it looks like the company is dealing with serious cash flow problems and is having to make some difficult choices in the short term to be able to survive.  

A couple of weeks before the announcement back on 1/28/2009 the company released encouraging news about Alagebrium:
http://phx.corporate-ir.net/phoenix.zhtml?c=100218&p=irol-newsArticle&ID=1243189&highlight=

CF

[bones54]

ive complete my series and about to return to my urologist for the measurements...

More angle.  Decreased size.  

Anyone else want to comment?

[newguy]

ive complete my series and about to return to my urologist for the measurements...

More angle.  Decreased size.  

Anyone else want to comment?

Was your size and curvature entirely stable prior to the xiafles injections?

With injections there is always a concern in my mind that there is at least the potential to do more harm than good. Of course, it depends what's being injected, if it's proven etc. It's all about playing the averages and the more information is available the better the choices we are able to make. Unfortunately the jury is still out of Xiaflex at present. From your other posts it does seem that you experienced more bruising and pain than would perhaps be expected.

I really do hope that this is just a temporary setback and that over the coming months you see improvements. If not, it might be worth trying the VED and/or light traction and taking pentox.

[ocelot556]

I can't see how one can put a good spin on the alagebrium report, despite what some optimists might be saying.

Even if the drug is purchased by another company, Two Phases of studies have been washed down the drain. That's approximately two years added on to any chance of seeing this drug on the market while they repeat these studies, and that's if the rights were bought and study goals were submitted today. Not to mention that there's the much longer Phase III trial that alagebrium never got to see. It doesn't matter if this drug cures Peyronie's with the first pill - if it doesn't go through the arduous years of testing, the FDA won't let us have it. It works with the same efficacy as it did when it was discovered in the '80s, but that doesn't do us any good if we can't get it!

Part of me thinks that this company was conducting these tests more as a dog and pony show, since they bought the corporate shell for Alteon to sell a different drug. WHY a company would abandon a drug that has the best possibility of any contemporary drug in the field to help REVERSE AGING, I don't know. Peyronies Disease aside, something that would ameliorate wrinkles and diabetic vascular damage... it has $$$ written all over it, yet it seems like it can't get anywhere...

As this has happened before with Synvista, as per the wiki article, and the fact that the drug itself has been around since the 80's...yeah. I'm not willing to say we're doomed, but for those of us who were hoping AGE breakers were the answer... we've got to find other answers. And I don't frankly buy that a member of this forum is taking the drug - where are they getting it? Why have they not posted results, or HOW exactly they're acquiring this drug which can't legally be sold? I'd be a guinea pig if I knew where to acquire it, by legal means or otherwise.

EDIT: I will add, however, that after some reading apparently the AGEs that alagebrium was supposed to break were apparently much more important in the rat model that the human model. We glycate differently, I guess, so those promising rat studies just weren't backed up in the human model, though there was apparently efficacy vis a vie changes in the heart chambers in humans. So while I agree it never was a "cure", the fact that a potential therapy has dried up in a time where there are virtually NO therapies being tested for our malady... it doesn't lend itself to giving hope to those of us praying for science to swoop in and save the day.

[George999]

It doesn't matter if this drug cures Peyronie's with the first pill - if it doesn't go through the arduous years of testing, the FDA won't let us have it. It works with the same efficacy as it did when it was discovered in the '80s, but that doesn't do us any good if we can't get it!

This is a misunderstanding of the role of the FDA.  There are plenty of "substances" on the market that are not approved by the FDA.  Alagebrium was around for a long time before it was picked up by Synvista's predecessor to potentially market as a drug.  It is a generic substance that has been tested this way and that way over the years.  The FDA ONLY prohibits the sale of generic "substances" when they 1) are being marketed as a drug or 2) have been shown to be a hazard to health.  Otherwise, no huge problem.  The real question is whether or not it will be picked up by a reputable vendor.  If not, you really have no guarantee as to the quality of what you are getting and that can be a problem.

I'm not willing to say we're doomed, but for those of us who were hoping AGE breakers were the answer... we've got to find other answers.

Just don't forget that Alagebrium is only the first and most primitive AGE breaker.  Other companies are doing research in this field and are already doing initial testing on other even better AGE breaker candidates.  Alagebrium was really the proof of concept in this whole chase.  It is already in danger of being made obsolete by newer more promising candidates.

And I don't frankly buy that a member of this forum is taking the drug - where are they getting it? Why have they not posted results, or HOW exactly they're acquiring this drug which can't legally be sold? I'd be a guinea pig if I knew where to acquire it, by legal means or otherwise.

Well, why don't you PM them and ask them where they are getting it?  People on this forum are getting Pentox without prescription.  Its not rocket science.  I myself have seen it marketed, I just didn't trust the vendors, thats all.  Its out there and available, I can pretty much guarantee that.  So here is at least one member that is taking Alagebrium, you can PM them and find out the scoop: Forum Post

So while I agree it never was a "cure", the fact that a potential therapy has dried up in a time where there are virtually NO therapies being tested for our malady... it doesn't lend itself to giving hope to those of us praying for science to swoop in and save the day.

As I stated above, other AGE breaker candidates with more viable futures are already undergoing preliminary research AND, if you really want Alagebrium, you can most likely get it, legally even.  - George

[Iceman]

Ok - i was just a bit hasty - i reckon that ive had improvement with ved and pentox - plus phsycologically i really am on top of it - keep up ved and pentox and youll be at least doing positive things