Update - vitiligo study with SCENESSE (afamelanotide) - Forum

Hi everyone,

I have some news that I'm delighted to share with VF: we've just announced that the FDA will allow the company to conduct our trial in the USA and the trial will commence shortly.

You can read the company's announcement here:

http://www.clinuvel.com/resources/cmsfiles/pdf/20110303FDAINSPIRE.pdf

The number one question we've been asked since announcing the study is 'how do I participate?'

We've compiled this document to help you understand the answer to that question:

http://www.clinuvel.com/resources/cmsfiles/pdf/20110303VitiligoCUV101Participation.pdf

I appreciate many of you will still have questions about our program as it progresses. Feel free to post them here, or you can email me at mail@clinuvel.com (be sure to include 'vitiligo' in your subject line). It might take me a couple of days to respond, but I'll do my best to get to everyone.

On behalf of the whole team, thanks again to everyone who has written to us with questions and comments of support, we really appreciate it.

Lachlan

Replies

Lachlan Hay September 18, 2014 at 3:12am

Hi everyone,

A brief update on the clinical trial program being run by Clinuvel in vitiligo.

Yesterday a paper was published in the academic journal JAMA Dermatology on results from our first study of the drug SCENESSE (afamelanotide 16mg) in adult patients with vitiligo. You can access the abstract at http://archderm.jamanetwork.com/article.aspx?articleid=1904928.

If you have any questions on the program or this study, please feel free to ask it here or via mail@clinuvel.com.

Many thanks,

Lachlan Hay

Head of Global Network and Communications

Clinuvel Pharmaceuticals Ltd
Lachlan Hay September 3, 2013 at 3:58am

Hi everyone,

Following our treatment results from 2012, the company has just announced follow on results from our US Phase IIa study. You can read full details on our website at http://www.clinuvel.com/en/investors/news-publications/announcement....

As always, I'm happy to try and answer any questions you may have. We'll also have a Q&A document online shortly.

Lachlan
- Lachlan Hay > Lachlan Hay September 3, 2013 at 9:43pm
  
  Our Q&A document is now online at http://www.clinuvel.com/en/blog/news/clinuvels-vitiligo-program-qa-...
Kenneth J Kramer December 27, 2012 at 2:42pm

Hi my name is Kenny I tried fame 2 help but it is not the cure:)
- anitha > Kenneth J Kramer December 27, 2012 at 8:08pm
  
  wat is that
Lachlan Hay December 18, 2012 at 12:37pm

Hi everyone,

I’m delighted to be able to share with you the first set of treatment results from Clinuvel’s clinical trials of our drug SCENESSE® (afamelanotide 16mg implant) in vitiligo. A copy of the company’s formal announcement is available for download here: http://www.clinuvel.com/en/investors/news-publications/announcement....

We’ve also released a new Q&A document focused on our results, an abbreviated copy of which can be found on the company’s blog: http://www.clinuvel.com/en/blog/news/qa-scenesse-successful-in-phas...

As we progress the program globally, I will aim to keep everyone up to date, but don’t hesitate to contact me with any questions.

Lachlan
- Bamsegutt > Lachlan Hay December 19, 2012 at 12:04pm
  
  Thanks for uppdate,when is it avelable on market?
  - anitha > Bamsegutt December 25, 2012 at 11:06pm
    
    ur question is been answered actually in their Q& A ie 2-to 3 years,,,,,,,
- HAL > Lachlan Hay December 18, 2012 at 3:06pm
  
  Thanks for the update. Sounds promising!
XvitiX October 16, 2012 at 5:59am

This approach, focusing on symptoms, does not really target the dynamics of vitiligo, the very early reasons why vitiligo emerged. Therefore, I do not think that it will be a solution for viti. Forcing pigmentation will not make pigmentation permenant.

Sorry saying this, but this is what I think, and I am very confident about it.

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