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Author Topic: Some additional information on lrhSOD and Peyronies Disease  (Read 5913 times)

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Luciano

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Some additional information on lrhSOD and Peyronies Disease
« on: April 03, 2011, 04:52:04 AM »

I am starting this thread as I did a little research after someone posted a question on IrhSOD and a quite promising study.

the study:
http://www.europeanurology.com/article/S0302-2838%2805%2900256-3/fulltext

Quote
Conclusion:
With the premise that conservative therapies for Peyronie's Disease generally are symptom-directed, i.e. analgesic and preventive against disease progression, and correction of deviation stays a surgical domain, liposomally encapsulated recombinant human SOD shows good efficacy when administered in patients with painful Peyronie's Disease lesions. Compared to placebo a statistical significant reduction of pain symptoms was observed resulting in an overall efficacy of >80% after 8 weeks of therapy. The expected rate of spontaneous disease progression was obviously reduced, as was morbidity and the need for future surgery, resulting in a high rate of patients satisfaction. There are no data on lrhSOD therapy exceeding 2 months, but a longer treatment time could possibly effect a more pronounced response on penile plaques and curvature. Future studies with a larger population may be difficult to perform, due to the relative infrequency and variable presentation of Peyronie's Disease. However, they are necessary to clarify the questions of optimal lrhSOD concentration and treatment duration.

After george's comment :
Quote
The major problem with lrhSOD is that it apparently was formulated specifically for this study and is apparently not in commercial production.  Certainly Levine speaks favorably of this treatment even seeming to wish that it was actually available to prescribe, which it pretty obviously isn't.  He also notes that the technique itself holds promise, in that other compounds might work in similar fashion, some perhaps even more effectively.  So it looks like they did this obviously successful study and there has been no follow up from the pharmaceutical industry to make the product available.  Obviously someone must hold the patent rights to it.  In the mean time five years have gone by.  It could well end up just being another missed opportunity.  Fortunately, though, we DO have the oral treatments.  - George
i dug a little into it..

Here is what I found:
Apparently they are using an ointment (gel) based on  an experimental drug called Lipoxysan

The company that created this drug wants 2 clinical studies, one for treatment of Peyronies Disease, a second one for burns:

Quote
To proof the potency of this lipsomal fomulation, two clinical trials will be performed. First, a clinical study for the treatment of Peyronie Disease (IPP) will be carried out. The efficacy of Lipoxysan against the inflammatory response will be evaluated. In the second approach, studies with Lipoxysan to reduce post-burn edema and improvement in wound healing will be performed. The treatment will be evaluated in first and second degree burns.

Now here is the interesting part. Allthough Lipoxysan is not sold in pharmacies, it is possible to get it if you are a lab.
You and me probably will not have the possibility to use it as is, but I think if you have a compliant pharmacist he could mix you a gel (or another topical mixture based on the product)

Here is what it says in the study:
Quote
A gel containing 2 mg liposomal recombinant human Cu-Zn SOD/g (Lipoxysan®) was manufactured under GMP conditions (Polymun Scientific, Vienna, Austria). The study drug and placebo were aseptically filled into 20 ml syringes which allowed controlled dosing of the gel.

Here is the link to the company in Austria:
http://www.polymun.com/
(its a frame page, so click in the right column on: Superoxide Dismutase)
there you can see the pricing is 300€ (about 420$) for 20mg) (2mg seem to be needed per application)
There is a pdf datasheet also

Of course it cannot be used as is. A pharmacist would have to make a mixture, but it seems that the product as it is, is not very stable and has to be used in a sterile environment.

-------------

additional info:
In October 2010, Polymun has concluded an exclusive agreement with Apeiron Biologics AG for development and marketing of SOD.

http://www.apeiron-biologics.com/

The only reference I found on their homepage:

# APN201 (rhSOD):
# Development stage: Phase II
# Development of a liposomal formulation of recombinant human Superoxide Dismutase (rhSOD) for therapy inflammatory skin conditions.
The human antioxidant enyzme Superoxide Dismutase is essential for protecting our cells from damage by reactive oxygen species. In October 2010, Apeiron has licensed recombinant human SOD from Polymun Scientific. A proprietary liposomal formulation of this enzyme that is well suited for topical application was already tested in several clinical trials and has shown therapeutic effects in a variety of inflammatory skin conditions. It is now intended to clinically develop liposomal SOD against skin damage as consequence of cancer therapies such as radiation therapy.

-------------

I will try in the next weeks to contact them, and see if they have allready a finished product or some topical gel.

Luc




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GS

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Re: Some additional information on lrhSOD and Peyronies Disease
« Reply #1 on: April 04, 2011, 03:24:59 PM »

Luciano,

Very interesting, to say the least.  Please keep us all posted on what you find out by contacting them.

GS
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BSSS

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Re: Some additional information on lrhSOD and Peyronies Disease
« Reply #2 on: April 08, 2011, 12:29:11 PM »


Thanks Luc for the info.

Hopefully lots of good can come from this research and approach.

BSSS
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Luciano

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Re: Some additional information on lrhSOD and Peyronies Disease
« Reply #3 on: April 09, 2011, 05:19:14 AM »

Well i talked to lots of people concerning this matter.
Primary results.
Yes I think i can get hold of the stuff, (My ex-wife could order it as she runs a hospital pharmacy with lab) and yes she could mix me a gel in her lab.

But its quite expensive.
1.4 mg SOD/day over 8 weeks would be: like 2800$
1.4*7days*8weeks = 78mg (so its the 100mg dose for 2000€ - considering that she wont charge me for mixing the gel thats around $2800,-)

a doctor that knows someone from the study told me:
it seemed to work for pain only. As for curvature
There was a "slight" improvement on 5 guys out of 39 (like 15% better)
this could have come from spontanuous heeling or other factors that are not forcably due to SOD

My problem is... I have no pain at all. just the curvature and indent. now roughly $3000,- is lots of money for stuff that will not really help in my case.
Luc

PS: I havent contacted the other company yet that licensed the stuff.
I will next week.


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dioporcolorisolvo

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james1947

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Re: Do you know this gel?
« Reply #5 on: October 15, 2012, 03:22:47 PM »

The subject was discusses in:
Some additional information on lrhSOD and Peyronies Disease - Peyronies Society Forums
But your link is not there and the trial was made in 2005
I find also a more old from 2001
Pilot study on liposomal recombinant human superoxi... [Eur Urol. 2001] - PubMed - NCBI

I will merge the two topics in a few days.
James
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Age 71, Peyronies from Jan 2009 following penis fracture during sex. Severe Erectile Dysfunction.
Lost 2" length and a lot of girth. Late start, still VED, Cialis & Pentox helped. Prostate surgery 2014.
Got amazing support on the forum

drew67

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Re: Some additional information on lrhSOD and Peyronies Disease
« Reply #6 on: August 15, 2015, 11:11:24 PM »

Looks like the product may be avaialble soon

LipoxysanTM
Polymun has incorporated human recombinant Cu/Zn-Superoxiddismutase (SOD) into liposomes. The concept of transdermally administered SOD as a radical scavenger for the treatment of inflammations has manifold possibilities; quasi as an alternative to cortisone treatment, but free of any adverse effects.
Polymun finished a phase III clinical trial for the transdermal application of LipoxysanTM in human volunteers suffering from IPP (Induratio Penis Plastica) successfully. Polymun is planning trials for other indications, such as atopic lung- and bronchial inflammation as well as heat- and UV-burns. In May 2015, Polymun has signed a license agreement with ScarletRed for development and marketing of SOD.
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james1947

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Re: Some additional information on lrhSOD and Peyronies Disease
« Reply #7 on: August 16, 2015, 01:16:14 PM »

Drew

Can you give us a link to the trial?

James
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Age 71, Peyronies from Jan 2009 following penis fracture during sex. Severe Erectile Dysfunction.
Lost 2" length and a lot of girth. Late start, still VED, Cialis & Pentox helped. Prostate surgery 2014.
Got amazing support on the forum

drew67

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Re: Some additional information on lrhSOD and Peyronies Disease
« Reply #8 on: August 16, 2015, 02:45:15 PM »

This is what is written on their site:  Polymun Scientific Immunbiologische Forschung GmbH

Polymun has evaluated the transdermal application of Lipoxysan™ in patients suffering from Induratio Penis Plastica (IPP, also Peyronie′s disease) in phase II and III clinical trials. The studies were conducted at three centers in Austria under the leadership of Claus Riedl, M.D. ([email protected]) and resulted in significant and rapid decrease of pain and amelioration of the other symptoms of IPP. Lipoxysan™ treatment was efficacious, free of side effects and convenient thus leading to high patient satisfaction. Details to the studies can be found in our publications " Pilot Study on Liposomal Recombinant Human Superoxide Dismutase for the Treatment of Peyronie′s Disease" and "Liposomal Recombinant Human Superoxide Dismutase for the Treatment of Peyronie′s Disease: A Randomized Placebo-Controlled Double-Blind Prospective Clinical Study".
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Freemason

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Re: Some additional information on lrhSOD and Peyronies Disease
« Reply #9 on: August 16, 2015, 09:07:52 PM »

Why haven't we heard more of this? Plaque size was reduced in 47% of patients. Curvature was reduced by 25% from 5-30 degrees. Disease progression was reduced to less than 10% compared with a normal avg of 40%.  Now it's a small study but to my knowledge this is the first topical cream or gel with this kind of results no?  Guess I'm wondering is the product approved and available?
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Jonbinspain

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Re: Some additional information on lrhSOD and Peyronies Disease
« Reply #10 on: August 17, 2015, 01:50:42 AM »

Reading this, it seems that it may be more effective during the active phase. It seems that these tests are some 10 yrs old, though! Which begs the question of what has happened since?


Liposomal recombinant human superoxide dismutase for the treatment of Peyronie's disease: a randomized placebo-controlled double-blind prospective ... - PubMed - NCBI
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