Introduction - Clinuvel - Forum

Hi everyone,

I work for Clinuvel, the company which earlier today announced it would commence trials in nonsegmental vitiligo with our drug, called SCENESSE (afamelanotide), with and without the adjunct use of narrowband UVB (NB-UVB) therapy. Steve Hargadon has posted our news here.

After a good discussion with Steve several days ago, I'd like to be able to bring you updates on our program through Vitiligo Friends when I can, and address any questions you may have about our drug or how we plan to use it in vitiligo. We've also set up a webpage at http://www.clinuvel.com/vitiligo as a central point for all study updated.

I expect there will be a number of questions on our study as we progress, and ask for your understanding if I can't answer questions immediately.

On a couple of more serious notes, I am not a physician and cannot provide medical advice. Further, I want to take an open approach to discussion, but am bound by certain confidentiality agreements and may not always be able to answer questions; such is the nature of our work. Finally, I am acutely aware of the rules governing these forums and want to play a positive, open role in discussion. If you have any concerns about anything I post please let me, or one of the moderators, know.

With that said, I'm hoping that I can help with understanding our work and learn much from all of you about vitiligo which I can then use to better our communications – online and offline.

If you ever wish to contact me directly, you can email mail@clinuvel.com.

I look forward to keeping you updated as our program progresses.

- Lachlan

Hi Julie,

We do intend to include sites in the US as part of this initial study. I have to say, straight away, that we don't normally recruit directly for our clinical trial (i.e. you cannot contact the company directly and ask to be on a study). The primary reason for this is one of data integrity - companies who sponsor clinical trials want to ensure there is no risk (real or perceived) to the unbiased nature of the data. Having direct contact with trial participants is one identified potential risk and is thus minimised.

A better way is to get in contact with your treating physician and/or the patient associations in the US and ask them about potential clinical trials. We work with physicians directly and generally have them recruit from their existing patient groups. Sometimes, however, they may also work with a third party (such as a patient association or regional healthcare registry) to identify further patients. I know, for example, that Vitiligo Support International maintains a list of ongoing research, and I'm certain there are others (perhaps even one on VF - does anyone know or think it might be good to start one?).

Our timelines at present remain linked to regulatory approvals, including from the FDA in the US. As soon as I have more information on this, I will share it with you.

Does that help?

Replies

Lachlan Hay January 31, 2011 at 9:28pm

Hi everyone,

A quick update from us which I thought would be of interest. We've published a new blog post on common myths surrounding vitiligo. You can have a read at http://www.clinuvel.com/en/blog/lightandhealth/little-white-lies-vi...

I'd appreciate any thoughts or feedback anyone has on how we could improve this (and future) posts and help everyone better understand vitiligo.

Thanks,

- Lachlan
- Dbas > Lachlan Hay February 2, 2011 at 3:24am
  
  any upate on the success of the trials? or any idea of the time frame we are now looking at lachlan?
  - Lachlan Hay > Dbas February 2, 2011 at 3:29am
    
    Not just yet Dbas. As soon as I can release info, it will be here.
Julie January 16, 2011 at 3:36pm

Thank you very much for the information. Will clinical trials for vitiligo begin in the United States? If so, how would we sign up or register for study? If not, is there a projected time you may have?
- Lachlan Hay > Julie January 16, 2011 at 8:40pm
  
  Hi Julie,
  
  We do intend to include sites in the US as part of this initial study. I have to say, straight away, that we don't normally recruit directly for our clinical trial (i.e. you cannot contact the company directly and ask to be on a study). The primary reason for this is one of data integrity - companies who sponsor clinical trials want to ensure there is no risk (real or perceived) to the unbiased nature of the data. Having direct contact with trial participants is one identified potential risk and is thus minimised.
  
  A better way is to get in contact with your treating physician and/or the patient associations in the US and ask them about potential clinical trials. We work with physicians directly and generally have them recruit from their existing patient groups. Sometimes, however, they may also work with a third party (such as a patient association or regional healthcare registry) to identify further patients. I know, for example, that Vitiligo Support International maintains a list of ongoing research, and I'm certain there are others (perhaps even one on VF - does anyone know or think it might be good to start one?).
  
  Our timelines at present remain linked to regulatory approvals, including from the FDA in the US. As soon as I have more information on this, I will share it with you.
  
  Does that help?
  - Julie > Lachlan Hay January 17, 2011 at 2:05am
    
    Yes. Thank you. I am interested in any information you can provide.
Lachlan Hay January 11, 2011 at 8:54pm

Hi everyone,

I appreciate we've been a little quiet of late on our program and I have a minor update to share with you. Earlier this week we released our first newsletter for the year and more information on the program will be announced in the coming six weeks.

Today we've launched the latest in our webcast videoseries focused on vitiligo, with a particular focus on narrowband ultraviolet B (NB-UVB) phototherapy. You can access this video on our website here and I've tried to embed in the post below.

In the coming months, Clinuvel intends to launch further video projects to help with the global understanding of vitiligo and our broader work. I'd really welcome your feedback and comments on these projects as well as any suggestions you may have on what you'd like to see from the company.

Thanks!

Lachlan
- Bamsegutt > Lachlan Hay January 13, 2011 at 3:07pm
  
  Hi Lachlan
  
  Thank you for updating us and sharing the new video . does it mean that NB UVB works as Protopic?
  
  Bamsegutt
  - Lachlan Hay > Bamsegutt January 13, 2011 at 11:45pm
    
    Hi Bamsegutt,
    
    Again, a disclaimer that I'm not a doctor and this is best discussed with your dermatologist.
    
    Protopic (tacrolimus) is, as I understand it, a topical/ointment, the use of which is off-label for vitiligo (although it seems to be widely used). While the aims of treatment with Protopic and NB-UVB may be similar in vitiligo (i.e. stop the spread of depigmentation and repigment skin), they have different applications. The adjunct use of tacrolimus and NB-UVB is widely reported in medical literature (I suspect there would be a few people on VF who could provide a first-hand account of their experience too).
    - Bamsegutt > Lachlan Hay January 16, 2011 at 11:02am
      
      Hey Lachlan
      
      Thanks for explanation, It is a very interesting video clip…I want to know about the immune systems who damage the melanocytes , are they a type of white blood cell called “lymphocyte” ?
      
      For those who haven`t seen it :- must see vedio
      
      https://www.youtube.com/watch?v=4qwCVHBnxR4
      
      Can you please ask the researchers if there is any deit or life style which can affect the immune systems (antibodies)
      
      We are glad that you join us and share our worries.
      
      Bamsegutt

of 4

This reply was deleted.