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New study of SCENESSE (afamelanotide 16mg) implant in vitiligo - Singapore

Posted by Lachlan Hay on November 3, 2013 at 12:06pm in Main

Hi everyone,

I've previously posted on Clinuvel's clinical study program, evaluating the safety and efficacy of our drug SCENESSE (afamelanotide 16mg) in generalised vitiligo. The company has just announced that we will start a new study in Singapore, with a protocol just finalised. You can read the full announcement at http://www.clinuvel.com/en/investors/news-publications/announcements/2013/clinuvel-to-start-a-phase-ii-vitiligo-study-in-singapore or in the attached PDF document. If you have any questions, feel free to ask them here, or drop me an email to Lachlan.Hay@clinuvel.com.

Thanks,

Lachlan

20131104CUV103.pdf

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Replies

  • Munir July 2, 2015 at 3:12pm

    wow nice something like this is happening in my country thats awesome!

    • Imran > Munir February 3, 2016 at 6:58am

      Hi Lachlan,

      Thanks for posting on this forum. Does SCENESSE have success on treating areas such as hands, wrist, fingers and feet?

      I've heard that treatment causes some tanning. Is this temporary?

      Sorry last question. Can the condition reoccur once treatment is stopped?

      Kind Regards

      Imran

      • Lachlan Hay > Imran February 4, 2016 at 11:54pm

        Hi Imran,

        It is not possible to answer these questions definitively at this time as studies are ongoing. Once we have more information I'll be sure to post it here.

        Lachlan

        • navin > Lachlan Hay February 25, 2016 at 8:49pm

          Hi Lachlan

          Is there any expected date on when SCENESSE trails will start in USA ?

  • Robot July 2, 2015 at 10:53am

    SCENESSE® (afamelanotide 16mg) available.

    Currently SCENESSE® is only available by a physician's prescription in Italy, under a law called 648/96, and in Switzerland. The 648/96 listing allows Italian physicians to prescribe SCENESSE® to Italian citizens diagnosed with erythropoietic protoporphyria (EPP). For more information on this scheme, see Italian access scheme 648/96. For more information on the Swiss access scheme, please contact us.

    Both the Swiss and Italian schemes are only available to permanent residents of these countries.

  • Andy Schiff July 2, 2015 at 10:05am

    Hi guys! Is there any news about Scenesse?

    • Lachlan Hay > Andy Schiff July 2, 2015 at 6:35pm

      Hi Andy,

      No further updates at present, but when I have news I will share it here.

      Lachlan

  • adnan halim June 24, 2014 at 4:32am

    if it works when will it be available to us ? and what would be its cost?

    wish u lots of luck

    adnan

    • Lachlan Hay > adnan halim June 24, 2014 at 5:16am

      Hi Adnan,

      These are difficult questions to answer right now. Should the Singapore trial prove successful, at least two further studies would be required (although they may be able to be conducted concurrently, depending on the circumstances). A 'best case' scenario would have us complete a clinical program in 2-3 years, then approach authorities for regulatory review, a process which varies according to region, but may be around a year.

      I know this is not the response many would hope for, but the clinical trial process needs to be rigorous to ensure we fully evaluate the safety and efficacy profile of the drug in vitiligo.

      Cost is impossible to answer at present, but would become clearer at the end of the regulatory review phase. There are too many variables to give a realistic answer to this question.

      Sorry I can't be more specific, but hopefully you've got some understanding of why the answers to these questions are vague right now.

      Thanks for your support.

      Lachlan

      • Colleen Sullivan > Lachlan Hay August 15, 2014 at 3:18pm

        Hello! 

        Will Scenesse be an option for vitiligo patients of all skin types? Or only for patients with dark skin complexions? Thank you for keeping us updated!

        Colleen

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