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

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Joshua

Discussions regarding Experimental drugs and treatments such as AA4500 and Pirfenidone to treat Peyronie's Disease.  By expeirmental we mean still in some level of the FDA approval process.  This is also the area to discuss other new techniques such as surgiacal or organ regenerating.


Old Forum

Posted: Wed Jul 06, 2005 3:43 pm      

Hawkman

The information on these trials seems very confusing. Bio specifics indicate they began a Peyronies Disease trial in 2004. I can only assume it was not phase 3 trials since they are supposedly recruiting for those now. One would think at the phase 3 trial level, fairly large numbers of patients and a variety of Urology Centers would be involved.

Since this is an direct injectable anti-collagen drug I suspect that I am out of luck. If I was not a candidate for VI because of plaque location then I would suppose I would not be a candidate for AA4500 injections.

Usually when there are phase 3 trials, it is not to difficult to find information about recruitment on the web. Has anyone found evidence of actual recruitment, not just a report that there will be phase 3 trials?



Old Forum

Posted: Thu Aug 04, 2005 11:13 pm      

j


See the link I posted in the "news" topic. Auxilium announced an agreement with another company that will supposedly manufacture enough AA4500 for Phase III trials.

Don't anyone hold their breath. These things grind on for years, announcements are cheap, and are often made simply to attract new investment or placate shareholders.



Old Forum

j      Posted: Sun Jul 03, 2005          4:33 pm    

Auxilium is the company that licensed Collagenase from BSTC after BSTC essentially admitted they'd never complete the FDA trials due to lack of money. Auxilium calls it AA4500 and claims to be seeking FDA approval for use against Peyronie's. And Auxilium just brought in $40 million in new investment. Some if it may well go towareds completing the trials for AA4500.

http://phx.corporate-ir.net/phoenix.zhtml?c=142125&p=irol-newsArticle&ID=724870&highlight=


I believe that as of today, AA4500 is our best hope.

Old Forum

dcaptain       Posted: Fri Jul 22, 2005      12:52 am    

I did a new lit search today on the Pub Med site, and found this, which was published in the June 2005 issue of the Journal of Hypothermia (any subscribers?? Just kidding.) Here's the abstract:

Role of hyperthermia in the treatment of Peyronie's disease: A preliminary study.

Perugia G, Liberti M, Vicini P, Colistro F, Gentile V.

Department of Urology, University of Rome 'La Sapienza', Rome, Italy.

Objective: Previous experience in the treatment of plaque with hyperthermia in orthopaedics led the authors to investigate the effectiveness of this approach in patients with Peyronie's disease.Patients and methods: The study population comprised 60 patients (aged 36-76 years) with advanced Peyronie's disease. Patients were divided into two groups (A and B), with 30 in each. Group A patients underwent local hyperthermia treatment, with 30-min treatment sessions twice a week for 5 weeks. Patients received a total of 10 applications, which reached a local temperature of 39-40 degrees C. A second cycle was repeated after a 1-month interval for a total of 20 treatment sessions. Group B patients were treated with intra-plaque infiltrations using 10?mg verapamil; they received one infiltration once a week for 3 months. Differences between the two groups, as well as between variables (before and after treatment), were analysed using Student t-test and Fisher test.Results: Hyperthermia significantly reduced plaque size and penile curvature and led to an increase in mean scores of erectile function (EF) domain, while verapamil had no such effects. Haemodynamic parameters were not significantly modified in either group. Hyperthermia caused significantly fewer side effects than verapamil infiltrations and was significantly more effective in preventing disease progression. There were no significant differences between the two groups in terms of pain reduction during erection.Conclusions: Results of this study stress the efficacy of hyperthermia in the treatment of advanced Peyronie's disease.

Old Forum

Hawk, AdministratorPosted: Fri Jul 22, 2005 9:17 am    
    
Very interesting Dcaptain. That converts to 102-104 degrees F. I wonder when they say "advanced peyronies disease " if the mean chronic / stable? I suspect not, since they discus pain, progression, etc.

Also was there a date on the study?

I think "Haemodynamic parameters" refer to peripheral blood flow but I am kind of vague on exactly what this means in light of increased erections.

Maybe you could throw the link on your post.

Some of these sites furninsh a more indepth report for a fee.

Old Forum

Joshua, Global Moderator     Posted: Fri Jul 22, 2005     10:38 am  


DCaptain:
I sent you a personal message about this article. I want to thank you for posting it. I find it fascinating. I would like to try and read the entire research report. I plan on looking for it. I would be happy to pay for the report if there is a fee. I will share it with the forum ; )
I find it interesting that this occurs at only 104 degrees. This may be simple minded but can we now conclude that heat applications could at least be beneficial?
I recall recent posts on BTC where a guy swore hot saunas baths were helping him. I have always believed hot baths helped me. I know this does not compare to the heat they are talking. However, it may show that heat applications are somewhat beneficial. I can't now see where heating pads, hot baths, warm thera patches etc... might not be a nice addition to our home based therapies.

Old Forum

j       Posted: Fri Jul 22, 2005      1:44 pm    

Very interesting; as always, I'd like to see the actual numbers.

This could save me some serious money. The A/C just went out in my car. Maybe I'll just not fix it, and drive around with the windows rolled up  

Old Forum

Hawk, AdministratorPosted: Fri Jul 22, 2005 2:57 pm    

A couple of things j. I think subjecting your entire body to heat would be a systemic solution to a localized problem. It could backfire and throw your entire body into a curve.  ;)

My final thought is that regardless of the science or method behind this study one thing is clear. We can be sure that on this one, they aren't being motivated by profit, that is, unless they sell donut shaped heat packs.

I have expiermented with both heat and cold. I kind of concluded "hmmmm, inflamation should respond to cold". I was so lacking in evidence I gave up.

Now I wonder, do you think the neighbors will complain if I sun my penis in the open window and call it medical therapy?
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Old Forum

j     Posted: Fri Jul 22, 2005      5:25 pm    

Depending on local ordinances, you might need to apply for a permit first. And be sure to use SPF 30 sunblock.


But seriously, wouldn't it be great if something like this worked? Obviously I have my doubts. But it's cheap, easy, noninvasive. Physical Therapists could start doing it tomorrow, it wouln't require any new FDA approval.

Old Forum

hawk, Administrator    Posted: Fri Jul 22, 2005    5:35 pm    
Quotej:
But seriously, wouldn't it be great if something like this worked? Obviously I have my doubts. But it's cheap, easy, noninvasive. Physical Therapists could start doing it tomorrow, it wouldn't require any new FDA approval.

It would be great and this information is enough to at least make me feel i would not be aggravating the situation. I have a handheld shower unit that I will end every show by directing over the area for several minutes. A few small hot packs should finish the job. I rate it right up there with Acetyl L-Carnitine. It has some evidence that it helps, little or no down side, and It is a hell of a lot more than my well known Urologist is offering me.

Old Forum

dcaptain       Posted: Fri Jul 22, 2005      9:12 pm    

Now I see the button for "popcorn" and "bacon," but where's "penis" on this microwave?

Sorry for the delay guys, sometimes posting at work isn't so easy. Here are the links to both the PubMed abstract:

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=16019862&query_hl=1

and the journal itself:

http://taylorandfrancis.metapress.com/app/home/contribution.asp?wasp=cb6064e00794422d861a386753223f16&referrer=parent&backto=searcharticlesresults,3,869;

That PubMed site is great if you haven't seen it. You can pull down a lot of great abstracts.

I agree - I think a little heat can't hurt, right? Hell, I'm swallowing supplements and I have no idea what they might do to me. What's a little heating pad gonna do?

dcaptain  

Old Forum

zenvault GUEST      Posted: Fri Jul 22, 2005     9:15 pm  

International Journal of Hyperthermia can be found at www.ingenta.com/content
The abstract shows 1 other affiliation to the study. It is the hyperthermia unit of Regina Elena Hospital, Rome,Italy.
In addition to the article "Role of hyperthermia in the treatment of peyronie's disease:A preliminary study" there is another in the same June 2005 issue called "use of local hyperthermia as prophylaxis of fibrosis and modification in penile length following radical retropublic prostatectomy" The second study evaluation was made on the effectiveness of local hyperthermia in reducing possible penile shortening following prostatectomy.

Old Forum

Hawk, Administrator      Posted: Fri Jul 22, 2005       9:27 pm  
Quotezenvault:
International Journal of Hyperthermia can be found at www.ingenta.com/content
The abstract shows 1 other affiliation to the study. It is the hyperthermia unit of Regina Elena Hospital, Rome,Italy.
In addition to the article "Role of hyperthermia in the treatment of peyronie's disease:A preliminary study" there is another in the same June 2005 issue called "use of local hyperthermia as prophylaxis of fibrosis and modification in penile length following radical retropublic prostatectomy" The second study evaluation was made on the effectiveness of local hyperthermia in reducing possible penile shortening following prostatectomy.

I would call this some very interesting information and I thank you for the valuable post Zenvault. The link seems to lock up on the main site. I am very interested as are others. Could you fix the link. If you need to email you can do so at admin@PeyroniesSociety.org

Thanks

Old Forum


ThisSux

I just can't believe how long this has been dragging on! The market for this drug must be absolutely huge considering the incidence of peyronies.

One would think that there would be a rush to get this out the door.  

dcaptain

Found a new abstract today guys.  I'm not saying "good," "bad," or "indifferent," but am passing it along to add to the discussion.  They list "the best results ever," but I'm not sure if or how this relates to mean results for the group (or maybe it is the mean?)  I'm not sure.  Anyways, just passing along.

Hope all is well with everyone.

dcaptain

**********************
Int J Radiat Oncol Biol Phys. 2005 Sep 15; [Epub ahead of print]

Results of radiotherapy for Peyronie's disease.

Niewald M, Wenzlawowicz KV, Fleckenstein J, Wisser L, Derouet H, Rube C.

Clinic for Radiooncology.

PURPOSE: To retrospectively review the results of radiotherapy for Peyronie's disease. PATIENTS AND METHODS: In the time interval 1983-2000, 154 patients in our clinic were irradiated for Peyronie's disease. Of those, 101 had at least one complete follow-up data set and are the subject of this study. In the majority of patients, penis deviation was between 30 and 50 degrees , there were one or two indurated foci with a diameter between 5 and 15 mm. Pain was recorded in 48/92 patients. Seventy-two of the 101 patients received radiotherapy with a total dose of 30 Gy, and 25 received 36 Gy in daily fractions of 2.0 Gy. The remaining patients received the following dosage: 34 Gy (1 patient), 38-40 Gy (3 patients). Mean duration of follow-up was 5 years. RESULTS: The best results ever at any time during follow-up were an improvement of deviation in 47%, reduction of number of foci in 32%, reduction of size of foci in 49%, and less induration in 52%. Approximately 50% reported pain relief after radiotherapy. There were 28 patients with mild acute dermatitis and only 4 patients with mild urethritis. There were no long-term side effects. CONCLUSION: Our results compare well with those of other studies in the literature. In our patient cohort, radiotherapy was an effective therapy option with only very rare and mild side effects.

dcaptain

Found another new abstract - this time surgical.  Am posting here under "News" but I guess it could go under "Surgery" as well.   Just adding to the body of knowledge - seems these guys may have a modified procedure (?).  

Hope all is well guys.

dcaptain

*****************************
'Straightening-Reinforcing' Technique for Congenital Curvature and Peyronie's Disease.

Mantovani F, Patelli E, Castelnuovo C, Nicola M.

Department of Urology, IRCCS Ospedale Maggiore, Milan, Italy.

Objectives: We report an initial randomised study on surgical techniques with subsequent intensive application of our procedure. Materials and Methods: We modified Ebbehoj-Metz technique by a 'straightening-reinforcing' (S-R) double stitch: the first performs the plication, the second tightens it, thus preventing tension during erection. This is different to the simple Ebbehoj-Metz stitch that only provides plication but, as it does not provide reinforcement, does not prevent recurrence. From 1995 to 2000 78 plications were performed: 60 for congenital curvatures (age range 18-32 years) and 18 for Peyronie's disease (Peyronies Disease; age range 36-58 years). During the first 3 years, i.e. between 1995 and 1998, patients were randomised to S-R plication (20 congenital and 5 Peyronies Disease) and Nesbit procedure (20 congenital and 5 Peyronies Disease), for a total number of 50 patients (40 congenital and 10 Peyronies Disease). The last 28 patients, operated between 1998 and 2000, were assigned exclusively to S-R plication. We delayed study publication in favour of an adequate follow-up. Results: No patient reported a decrease in erectile function and all reported easy vaginal penetration within 3 months. In 60% of the patients undergoing the Nesbit technique, restoration of a fully satisfactory coital activity was delayed because of pain during erection; 35% of all patients had some problems with the coronal suture which disappeared 1 month after the operation, and 15% reported decreased sensibility of the glans. Recurrence rate was not significant for all patients of all groups, even if 3 Peyronies Disease patients of the S-R plication group and 1 Peyronies Disease patient of the Nesbit group received no benefit from the operation. Conclusion: S-R plication is not better than the Nesbit procedure. However, for low degrees of penile bending, both congenital and acquired, we do not think it strictly necessary to perform the more invasive Nesbit operation (requiring opening of Buck's fascia, detachment of the neurovascular dorsal bundle or urethra and albuginea excision). Modified plication may be a minimally invasive and effective treatment suitable for most curvatures treated in day clinics and under local anaesthesia.

j

As many of you know, Peyronie's and Dupuytren's Contracture are generally considered to be 2 aspects of the same underlying disease. Now a research group claims they've found the location of the underlying chromosomal abnormality.

I found this on http://centerforgenomicsciences.org/research/, which is a web site describing research projects at the Center for Genomic Sciences, part of the Allegheny-Singer Research Institute, ASRI, the research arm of Allegheny General Hospital:

"Dupuytren contracture is a disease of the fascia in the hand that does not usually onset until the fifth or sixth decade of life and is most prevalent among the Xanthocroix peoples of Northern Europe. This project was begun in 1995 in collaboration with our Swedish colleague, Dr. Ake Nystrom. Dr. Nystrom, currently at the University of Nebraska in Omaha, Dr. Ehrlich and Dr. Hu have completed several specimen collection trips to Sweden to access informative Scandinavian families that Dr. Hu and Dr. Preston successfully used to identify a locus on chromosome 16. "



jess99504

J
Just a short note.
I have heard that Scandiavian are prone to this. Most folks that I know are of Swedish and Norse decent like myself and have it. Seems that sometimes it goes hand in hand with Peyronies Disease. Oh well.... Another bump in the raod.


dcaptain

Is it just me, or does this seem like a fairly big deal?  Maybe not?  

j

I think it's been known for quite a while that Dupuytren's is hereditary, and that Dupuytren's, Peyronie's and Ledderhose are essenitally the same condition.

Like a lot of medical 'breakthroughs' the first result will probably be a test that will tell you, while you're still young, that you're going to get Peyronie's Disease later in life and there's nothing you can do about it. Great.

Eventually, some researcher will find the specific bad gene, and then unravel exactly what that gene does, and - some day - hit on a way to compensate for the defect. We might all be dust by then, but future generations won't have to endure this curse.


Hawk

J,

A fellow Swede thanks your for this very interesting information.
Prostatectomy 2004, radiation 2009, currently 70 yrs old
After pills, injections, VED - Dr Eid, Titan 22cm implant 8/7/18
Hawk - Updated 10/27/18 - Peyronies Society Forums

j

dcaptain, actually this is a big deal, sort of. While there is apparently no significant research being done on Peyronie's, that's not the case with Dupuytren's. That research paper starts out with this statement:

"Dupuytren's contracture (DC) (OMIM 126900) is the most common connective tissue disease of mankind..."

I've seen  other research on Dupuytren's too. Tissue changes, cell biology, the  biochemistry of fibrosis.  Genetics people have been interested in Dupuytren's for years because it's fairly easy to study - there's a nice geographic/ethnic trail to follow. Hand surgeons all over the country deal with it every day. Insurance companies pay big bucks.  

Basically few researchers would want to work on Peyronies Disease because it's so darn difficult. Hard to find patients. Guys don't like to talk about it. Hard to get objective measurements. Hard to take tissue samples. But with Dupuytren's, announce a study and patients will beat a path to your door, happily show you their messed-up hands and let you jab and poke them.

When they figure out Dupuytren's, we'll have the answer to Peyronie's too.

kevin

As I wrote on another thread. the connection with DC may be our only hope for getting collegease drugs (like AA4500) investigated and approved.

On a different, very speculative note:  Scandinavian countries have long had the reputation for having a high standard of living, including relaxed sexual mores, while at the same time they mysteriously have higher suicide rates than the rest of the world.  I wonder if the larger numbers of cases of Peyronies Disease in that region could account for enough additional suicides (with Peyronies Disease-related depression going underreported, understandably) that the total would therefore exceed  that of other countries.  After all, suicide numbers are not massive in the first place.  If statistics can show that a disproportionate number of Scandinavians who took their own lives for reasons unknown were 45-60 years old, I would really suspect this is the mystery factor.

j

A grim thought, kevin.  

I've seen some numbers for the prevalence of Dupuytren's in Scandinavia and in particular, a study in Iceland showed a high number:
 http://www.emedicine.com/derm/topic774.htm

I haven't seen numbers for Peyronie's in Scandinavia It's clear that there's a strong linkage between the problems - according to Dr. Mulhall's web site, 15% of men with Peyronies Disease are found to have Dupuytren's as well.  Note that  Dupuytren's might appear later in life - after the Peyronie's - so the number could well be higher.  

bentley

I  read this on a Dr. Whitehead's Site:
I am now performing the "Single Relaxing Incision for Correction of Penile Curvature based on Geometrical Principles (Egydio Procedure)" after having been trained by Dr. Paulo H. Egydio in Sao Paulo, Brazil. Does anybody know if this is a different surgical intervention than Cross stitching the backside ( ie does it result in a two inch reduction of length for which massive psychological counseling would presumably be needed together with a pocket full of anti-depressants

kevin

Once in a while you actually find something useful in the middle of all the stupid graffitti ((junk posting) on the old BTC forum:

From a Yahoo business news item:

"In August 2005, Auxilium signed an agreement with Cobra Biologics Ltd.
for the further development of the manufacturing process, scale up and
manufacture of clinical supplies for AA4500 for both Peyronie's and
Dupuytren's Diseases."

and

"Research & development costs for the quarter ended September 30, 2005 were $4.5 million compared with $4.9 million in the comparable year-ago period. The decline reflects lower in-licensing fees, partially offset by an increase in spending on various product candidates, particularly manufacturing scale up for AA4500, ongoing investment in developing the licensed transmucosal film technology and Testim phase IV clinical studies in hypogonadal men with type II diabetes."

Now to find out the where and when about those trials...

Full article at:

http://biz.yahoo.com/prnews/051108/nytu080.html?.v=27

kevin

See this forum's "News" thread for latest developments, excerpted from this November article:

http://biz.yahoo.com/prnews/051108/nytu080.html?.v=27

Larry H

One of the most comprehensive reports on all aspects of Peyronies Disease is an article written by Dr. Eli Lizza at the URL shown below. The article covers in depth almost all of the topics on this forum. There is good information on iontophoresis (EMDA) which is a current topic on the forum.

It may have been posted here before as I have not gone back and checked all the topics, but in any case it's a good report.

Larry

http://www.emedicine.com/med/topic3422.htm

j

Thanks for the link, Larry. It's an interesting summary.

Unfortunately it seems to answer all the questions except 1: do any of those therapies work?  I always end up at the same place with that one. For each treatment there's a small poor-quality study that appears to say "yes, maybe". And a bunch of posters on forums like this saying - I tried it and it did nothing. Years go by and the question is never resolved - the list of therapies continues to grow but nothing is ever really settled. We just get more urologists prescribing more things, more money being spent, and seemingly little if any improvement for patients.

So that's my message of cheer for the new year.




bentley

I would have to agree that neither this nor the preceding couple of years have been cause for party hats and noise makers unless you are a marketeer peddling the old potions, we have at the very lest been able to show that there are a significant number of us who are affected and willing to share our journeys. some interest in  collagenase, refined surgical techniques, more demanding and informed patients. .  . these are all pretty good things.  Happy New Year and many more to follow. Bentley

robm

Something positive to start the new year off right.  


Dr. Anil Kapoor MD FRCS(C) has been treating Peyronies Disease with ESWT since July 2003.

He will be interviewed on the 'Talking Sex with Sue' program on Sunday January 15th, 2006 at 11pm EST (10 CST) with repeats at 2am, and the following Thursday, on the Oxygen channel.

The interview will provide general Peyronies Disease information to listeners and raise awareness of Peyronies Disease within the general public.

If you get the Oxygen channel, we hope you will tune in.  Please forward this notice to physicians, or others who may benefit from the information.

Sincerely
Robert Mitchell
PainFree ESWT
www.painfree-eswt.com
1 866 444 3798
peyronies-info@painfree-eswt.com


Hawk

Thanks to J for the following.  Most of it is his, with a bit of a rework for posting on our website.

Here is, apparently, a recent PowerPoint presentation from Auxilium  makers of AA4500 (collagenase), that answers some questions, sort of.  This drug is going through FDA trials as a means of remolding scar tissue in at least a few different conditions including Peyronies Disease.

http://www.secinfo.com/d14D5a.v27Ry.d.htm

The AA4500 slides are pretty deep down the page.  Note the proposed timeline showing AA4500 being marketed in 2008-9.  As J notes, Often investor presentations are overly optimistic.  Other interesting points: they claim verapamil is "ineffective" ,that surgery is the only "approved" treatment for Dupuytren's (not true) - and, that AA4500 has worked on Peyronie's. Their initial level II trials used 9 injections and they hope to reduce that number in their IIb trials.
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

kevin

Pirfenidone is an investigational anti-fibrotic drug that was in clinical trials not long ago for use against pulmonary fibrosis.  At least one participant in those trials happened to also have Dupuytren's Contracture (a condition with links to Peyronies Disease) and he reported to a newsgroup that it resolved his DC.  Pirfenidone appeared promising and it was discussed on the BTC board last year (by Joshua, among others) but nobody has even mentioned it since then.   I was especially interested in hearing from the person who posted that he was in an upcoming trial of the drug for a fibrotic disorder and is also a Peyronies Disease sufferer, or so he says (we all know how the BTC board is).  The old thread is this one:

http://www.biospecifics.com/forum/readThread.asp?forumID=14&threadID=3434

Some studies are discussed in the following two links:
http://www.clinicaltrials.gov/ct/show/NCT00063583
http://www.keepmedia.com/pubs/PRNewswire/2005/03/29/790464
http://www.intermune.com/wt/itmn/pirfenidone

kevin

(Copied from "New Topics" thread)

couldbeworse wrote:

"It looks like SUNY Stony Brook is doing some work with collagenase: http://www.clinicaltrials.gov/ct/search?term=collagenase&submit=Search
They're teaming with Biospecifics in trials for Duypuytren's and Frozen Shoulder.  Why not Peyronies Disease?  If no one on this forum tells me why not, then I'll ask the PI at Stony Brook, Why not?..."

If the researchers at Stony Brook are testing a treatment fo DC, they are clearly not in the Urology department and may not even know of the connection with Peyronies Disease.  Even if they are made aware of it, I doubt they will even consider injecting collegenase where it needs to be injected for Peyronies Disease purposes.  I guess the best thing to do is make sure they do know (with links to the sources of that info) and ask they they confer with their colleagues in Urology.  In fact, if the study is large enough, there is likely to be at least a couple of test subjects who actually have both DC and Peyronies Disease.  So maybe the researchers can be convinced to include Peyronies Disease among the many other conditions they ask about in their recruiting questionairre.  That way, any incidental effect of the drug on Peyronies Disease could be noted at the end of the trials and, if it's beneficial, flagged for further study.  Enter the Urologists.....  

Hawk

Again, thanks to Mark's support for this link.  My first, 1 second impression was that it would be a bunch of the usual hype, but this is a very interesting article.  I suggest you read the entire articles.  They are short.  This actually worked in rabbit penises even after removing all corpra cavernosa tissue.  Clearly there is a long way to go but they have come a log way.  If I was in my 20"s or 30's and had Peyronies Disease, I would be fairly confident that major help is on the way from this and other research.

"In the study, adult male rabbits with severely damaged penises received a graft of specially engineered penile tissue. The animals then re-grew full penises that functioned normally...

Dr. Anthony Atala, director of the Institute for Regenerative Medicine at Wake Forest University in Winston-Salem, N.C. His team reported its findings Tuesday at the American Urological Association annual meeting, in Atlanta."

Here are two links incase one goes inactive.:

http://www.healthday.com/view.cfm?id=532858

http://news.yahoo.com/s/hsn/20060523/hl_hsn/scientistscreateartificialpenis
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

ComeBacKid

Mark,

Way to catch those articles, very interesting, plants seeds of hope in myself.  Hawk you never know man, in another 5 years they could have that science perfected.  I think its important to keep hope with this disease, just not unrealistic hope.  Perhaps someday it will be as easy as the doctor injecting the tissue into my penis, which can than regenerate into new tissue and grow.

What about the collagenese injections with Auxillium? I think for the average person and myself we hear FDA trials level 1,2, and 3, and that Auxillium is in phase 2, but what does this mean, how long is phase 2, how long is phase 3?  What happens after that, you can try the injections?  Will the FDA publish the results of their studies so all of us sufferes can see the success of collagenese injections?

PDLabs claims their in phase 2 of FDA trials, someone said that when they called them like 4 years ago they claimed they were in FDA trials, do the trials take this long?  What is the average time frame to go through all the phases?  I think a lot of people don't understand these time frames, if anyone could give a detailed response on what each phase is and how long the whole process takes it would be good for everyone to understand, anyone want to give us a minor in FDA trials?

ComeBackid

Tim468

Effect of intralesional interferon-alpha 2b combined with oral vitamin E for treatment of early stage Peyronie's disease: A randomized and prospective study

Tansel Inal, Zafer Tokatli, Murat Akand, , Erol Özdiler and Önder Yaman

Department of Urology, University of Ankara School of Medicine, Ankara, Turkey

Received 26 April 2005;  accepted 2 November 2005.  Available online 11 April 2006.




Abstract
Objectives
To compare the efficacy and safety of intralesional interferon-alpha 2b combined with oral vitamin E or intralesional interferon-alpha 2b alone or oral vitamin E alone for the treatment of Peyronie's disease.

Methods
From January 2000 to March 2002, a total of 30 consecutive men with Peyronie's disease were randomized prospectively into three different treatment groups. All the patients were assessed objectively with penile duplex Doppler ultrasonography for plaque size, location, and presence of calcification before and after treatment. Subjective data were obtained by querying about the improvement in penile pain and by using the "global efficacy question" for the assessment of the quality of sexual intercourse at the end of the study. A total of 5.0 × 106 U of interferon-alpha 2b was given once per week directly into the plaque for a period of 12 weeks. Patients received 400 IU of vitamin E orally twice daily for 6 months.

Results
At the 6-month follow-up visit, we did not find any statistically significant changes in the objective parameters when compared with the initial findings in each group or among the three groups (P >0.05). We did not observe any clinically significant improvement in the subjective parameters among the three groups (P >0.05). However, all patients who were treated with interferon-alpha 2b experienced brief flu-like side effects.

Conclusions
Our findings indicate that 5 million units of intralesional interferon-alpha 2b injection therapy either alone or in combination with vitamin E does not appear to be clinically effective in the management of early stage Peyronie's disease compared with only oral vitamin E.

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

Hawk

[quote ]
interferon-alpha 2b injection therapy either alone or in combination with vitamin E does not appear to be clinically effective in the management of early stage Peyronie's disease compared with only oral vitamin E.
[/quote]

And we all know how well vitamin works.  One of the studies in liams posted link (under "Resource Liabrary") indicated no difference in Peyronies Disease with or without vitamin E.
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

kevin

Someone on the Yahoo group for Peyronie's & Chordee just turned up the patent record for a Peyronies Disease treatemnt using collagenase.  The patent dates from 1982 and was issued to Dr. Gelbard, whom we all recognize is now one of the best-known urological surgeons in the country.  The link given in that post (and included below in mine) is an official and detailed description of the patent.  However the posting went on to claim that the treatment was found ineffective, that the patent has expired, and, curiously, that the material from the experiments is still being sold today!

This is all very confusing because we know collagenase is again being studied today as a possibly very effective treatment for Peyronies Disease.  Auxilium Corpoation is the current holder of a (different?) patent for an investigational collegenase drug they call AA4500.  If they are not one and the same, then the two patents must be different is some substantial way, but how? (The 1982 patent seems to cover every variation of the substance and every imaginable way of administering it for Peyronie's.)  In any event, if we can verify that collagenase indeed was found ineffective decades ago, it would mean that our hopes for AA4500 are dashed - or am I missing something?

http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.htm&r=1&f=G&l=50&s1=4,338,300.PN.&OS=PN/4,338,300&RS=PN/4,338,300

ComeBacKid

Kevin,

I to have heard that same rumor and I can't remember where exactly- being that collaganese already did not work when tried.  This to made me wonder am I getting my hopes up for something that will turn out to be ineffective?

However, just recently I was talking to someone who was at the AUA and met the head doctor doing the collaganese injection trials that are under way right now apparently.  From what he tells me things are going well, he seemed to hint to the person I talkedto that they are seeing positive results, however the person I talked to said the doctor told him Auxillium is being very cautious and purposely not overhyping their product.  This gave me some positive hope and I wanted to pass it along after I read your post.

Your questions are very good and common sense makes me ask why Auxillium thinks collaganese would work now?

This is something that we should definately look into, maybe Tim or any other doctors or physicians can inform us on this subject.

ComeBackid

j

Collagenase itself is an enzyme produced naturally by your body. It dissolves collagen, which is a principal component of Peyronie's fibrotic plaque.

Verapamil (and possibly interferon) stimulates the body's own production of collagenase. Unfortunately it seems not to work very well, at least so far.

I know there are several forms of collagen, and there may be different forms of collagenase too. I believe the BSTC patent is for an 'injectable form' of collagenase which is supposed to be more effective than whatever was tried back in the 80s.

Previous studies have already shown conclusively that it can work for Dupuytren's contracture, by dissolving enough of the band to allow it to be snapped.  It's use for Peyronie's might be more problematic, but that's what Auxilium is trying to work out.


kevin

According to Gelbard's early-80's patent, the administration WAS to be  "directly into the plaques which form in the course of the disease" and is described as "interlesional".  We can only assume that any subsequent patent-based experiments must have been conducted accordingly.  Though I haven't read anything that verifies the reported findings that the drug was found ineffective, it does seem likely since we all would have heard about anything at all positive.

Still, I'm hoping that the new experimentation is based on some significant variation in either the substance or delivery, and is therefore not just going down an old forgotten road that leads to a dead end.  If anyone knows for sure what is different between then and now, please let us all know.  In fact, with collagenase trials supposedly underway now (and previous ones completed), why is it that no one on this forum has reported being a participant?  Is our forum (or the study) so small that it's statistically unlikely that we have a participant among our members?  Or perhaps I just overlooked a post from someone about that...

wantitstr8

I don't think the trials are underway.  My Uro is Dr. Levine and I asked about the collagenase treatment last Friday.  He said he is working together with some other Doc's to develop the protocols for the trial.  He thinks it may get underway later this year.  He is encouraged and thinks this may be a viable treatment.  I think if trials were underway, he would know about it...

ComeBacKid

Wantitstr8,

I was told they are underway and that some people in the study are receiving placebo injections.  Those people who receive those, are then told at the end of the study and will be allowed to get the real injections for free for taking the time to participate in the study.  This is what was passed on to me by a reliable source who was at the AUA and said they spoke with the doctor doing the studies.  I'll press for more information and see if I can't find out some more facts about the trials.  The company is located here in Pennsylvania, but I've never heard of the town, I wonder if they are doing the trials here?

ComeBackid

kenm

i dont believe that is true.  I talked to the company myself.  The trials have not started yet.  There is still a lack of study drug and it does not sound like the protocol is even finalized yet.  I think Auxilium is dissappointed about this.  The coordinator for the study does not even work in PA but in a home office in NJ.  The good news is that Auxilium appears very committed to bringing the product to market and something I have been thinking of recently if they get a frozen should indication first then certainly urologists could start using it off label if inital results are promising.

ComeBacKid

Kenm,

You could be quite right, I will check back with my source and question them in more detail on this.  Perhaps they are confused or simply wrong. I guess if we wanted to check we could call the company ourselves and it sounds like you did that, good work!  

ComeBackid

howcanthisbe

so when is this new injection going to be out? Dont the trails take like 4 years? They got to find a cure, they got to.