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CUV9900 (Read 3014 times)
newnameolduser
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CUV9900
09/24/10 at 13:02:55
 
Not been keeping up to date with news from Clinuvel due to the disappointing stagnation of the share price but when i last looked at their website I noticed this:
 
"CUV9900 is an alpha-Melanocyte Stimulating Hormone (alpha-MSH) analogue which the company intends will complement Clinuvel's lead product SCENESSE® (afamelanotide [melanotan-1]). It belongs to the same family of molecules, known as melanocortins, as afamelanotide [melanotan-1].
 
Recent research has shown that CUV9900 is a potent skin protectant. Clinuvel intends to launch CUV9900 in various new formulations. Formulation work has commenced and Clinuvel expects the first formulations to be available for clinical testing in Q1 2011."
 
Anybody got anymore info on this?
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Big_Jake
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Re: CUV9900
Reply #1 - 09/25/10 at 14:18:04
 
no and i have been looking like crazy for the chemical make up of this. in a report a few years back, an analyst listed the schedule of compounds that clinuvel owns the rights to. havent had the time to check myself, but that would be a good starting point.  one thing i noticed in the recent patent grant from the USPO was the reference to NDP-MSH used in conjunction with another melanocortin.
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Re: CUV9900
Reply #2 - 09/25/10 at 18:08:16
 
Thanks for your response Big Jake. I'm curious, do you have any kind of chemistry background?
 
Also, are you a shareholder? If so, how are you feeling about the potential for your stock in the long term? There just seems to be no movement with regards to news. I'd love for Clinuvel to be getting more attention for being closer to releasing the implant to market for one of their listed conditions so that HOPEFULLY it gets closer to off-label provision (which HOPEFULLY will boost the company's value). Am I right in thinking this?
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« Last Edit: 09/26/10 at 13:51:35 by newnameolduser »  
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Big_Jake
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Re: CUV9900
Reply #3 - 10/03/10 at 21:40:08
 
yes i am a share holder, and have been in and out of this stock for years. a person can make decent money in sufficient volumes and patience. as far as long term, i have some IRA clvly shares if that is any indication.  I was taugh a long time ago to invest in what interests you and in things that ones self would purchase.  
 
I know a lot of people are frusterated at the sp and the lack of movement. Many believe this should skyrocket based on the progress and news, but most clinuvel investors ignore the simple facts too. fact is, this is in a brand new class of drugs that have not been seen by regulators. fact is this is an ADR traded on the pink sheets in tiny volumes, this is a fledgeling company with one drug, this is not an approved drug at this point, several self imposed deadlines have been missed, institutional investors are dropping like flies, there is not any major dealings with big pharma at this time... in short nothing is tangible with this stock. most investors are too close to this stock to face the reality this is a very high risk investment.  there are indicators mounting that this could happen, but still grossly outweighed by the cons.  
 
EPP approval will gain public interest, but the real money will only happen in the case of PMLE or vitiligo. once these large indications are trialed and approved, product price will drop and off label use will begin. sky is the limit from there. i will not speculate on future share price, but how many investments really see gains of hundreds of percents??  $ 1.00 ($10 in ADR) would be a 500% gain for me.. the rest is gravy.
 
and no im am not a chemist, but have some training. literally hundreds of hours of research on this drug have led to my long term commitment.  
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Re: CUV9900
Reply #4 - 10/09/10 at 18:52:14
 
http://www.prlog.org/10984906-sadif-analytics-rates-clinuvel-pharmaceuticals-limited-as-low-quali
ty-company.html
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Re: CUV9900
Reply #5 - 10/23/10 at 14:31:01
 
Big_ Jake
 
You say the big money is in PMLE and Vitiligo once these large indications  
have been trialed and approved. My question is what have Clinuvel/ Epitan been trialing over the last 10 plus years.
 
In 2003 Epitan reported outstanding results with their phase 11b clinical trials and  
the results represented a massive step towards commercial development but now the emphasis is on EPP and possible vitiligo. What indications were they testing 7 years ago?
 
My belief was this drug was intended  for fair skinned individuals to help reduced sunburn and most importantly skin cancer which accounts for millions of people worldwide.  
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Re: CUV9900
Reply #6 - 10/23/10 at 16:11:26
 
the previous managments have bungled the trials from day one, representing this as a tanning drug. yes tanning does have a protective effect to it, but is largley seen as cosmetic agent. Skin cancer trials are long winded.. the current AK trials from clinuvel has been going on since 2007 as a phase II. they have to have years of data to show long term effectiveness as a preventative.  they have had to prove this drug will have little possibility to be used as a cosmetic.. thats why its an implant and outrageously priced. and since this is a first in class drug they have to provide ALL the data for approval.. they cannot reference previous trials and cite studies etc because there is none! they are doing all the heavey lifting. and then of course.. how do you run a truly blind study when you either tan or you dont when receiveing the drug or placebo? how do you rate a medicinal benefit when the only factor is pain tolerance?? nailing down an acceptable rating format and trial protocol based off of quality of life to appease the regulators seems to be have been a big issue.  to top it all off, there is little known about how the melanocortin system actually works and how it effects other processes.. the road for a first in class drug is a tough one and they have spent the past 10 years refining a path to approval..
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Re: CUV9900
Reply #7 - 10/31/10 at 19:36:25
 
Anyone know what is the earliest date and also the more probably date of CUV9900 being approved for use?  
(e.g., 3Q2011 best case scenario, 1Q2012 more probable ?)
 
I read that CUV9900 is currently in Phase III trials and that'll end in 1Q2011 and "Clinuvel will file its first regulatory submission to the European Medicines Agency (EMA) in second quarter 2011 on the basis of the results from three EPP studies: CUV017, CUV029 and CUV030." -  quoted from realpennies website.
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Ferrara
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Re: CUV9900
Reply #8 - 10/31/10 at 19:46:30
 
Anyone know if Clinuvel's "Nanoparticles from English ivy" (which they found protects against UV) would need FDA approval?
ref. http://clinuvel.com/cuv9900/1050
Also, anyone know approximately when one or more skin care makers might start using Clinuvel's Nanoparticles and if Clinuvel would earn revenue from this (such as licensing their technology)?
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Re: CUV9900
Reply #9 - 10/31/10 at 22:50:41
 
Quote from Ferrara on 10/31/10 at 19:46:30:
Anyone know if Clinuvel's "Nanoparticles from English ivy" (which they found protects against UV) would need FDA approval?
ref. http://clinuvel.com/cuv9900/1050
Also, anyone know approximately when one or more skin care makers might start using Clinuvel's Nanoparticles and if Clinuvel would earn revenue from this (such as licensing their technology)?

 
 
Hello, Clinuvel has had nothing to do with ivy nanoparticles. All they've done is added a link to the following story:
 
http://www.cosmeticsdesign-europe.com/Formulation-Science/Nanoparticles-from-Eng lish-ivy-protect-against-UV
 
-Scott
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